chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt developed small red sore spot on Saturday morning. Got better on Monday night. Currently red, warm indurated 50 x 60mm and arm uncomfortable with movement.
INJECT SITE REDNESS SPREADING MORE THAN NORMAL TOWARD THE ELBOW.
Constipation; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-May-2021 and was forwarded to Moderna on 07-May-2021.    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 CONSTIPATION (Constipation) 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 CONSTIPATION (Constipation). At the time of the report, CONSTIPATION (Constipation) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
Patient was admitted to the hospital with COVID + testing, hypoxia, and required treatment with IV dexamethasone, remdesivir and supplemental oxygen.
About 9-10 days after vaccine exp low grade fever and body aches lasted 3-4 days.
Information has been received from a physician concerning four female patients who were vaccinated with doses of GARDASIL vaccine. Subsequently the patients experienced postural hypotension. Unspecified medical attention was sought. At the time of this report, the outcomes were unknown. Follow up information was received from a physician on 26-MAY-2009. The patient was the nurse's daughter. The physician stated that after further discussions, it was decided that there was no relation to these events and the GARDASIL vaccination. The physician was confident that the patient was fine. This is one of several cases from the same source. No further information is available.
Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Additional Details: Patient fainted twice while at the pharmacy vaccine waiting area. Her mother held her while she was fainting. She experienced twitching/shakiness during the times of fainting. Gave her juice, water, and cookies. She laid down for about 20 mins. Overall time of watching patient was 1 hr. Her mom refused epipen and 911. Left feeling better. Patient does have hx of fainting from vaccines and was disclosed at time of vaccination.
Said after 1st dose his arm was a bit sore after getting vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Said after 1st dose his arm was a bit sore after getting vaccine".  Additional Information: Reporter (patient) said that he received 2nd dose of vaccine today. Doesn't believe vaccine was administered properly. Said didn't feel anything, there was moisture after needle was pulled out, had moisture on sleeve. Had also spoken to person that gave vaccine and said they were confident in giving vaccine. Caller doesn't think so. Said after 1st dose his arm was a bit sore after getting vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pain in arm both times.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 12:00 (Lot number: EN6207) at the age of 32 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Aortic bicuspid heart valve" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "not recovered", described as "Pain in arm both times.". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient had no known allergies. Patient did not receive any other vaccines within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Headache, fatigue, nausea, heavy legs, whooshing in the head, temperature, exhaustion, joint pain, knee pain, sore leg muscles , sore arm joints, sore lower back
Potential medication side effect: Patient states after receiving Janssen vaccine, daily activities are now harder to complete without rest in between bouts. Patient states was previously diagnosed with Hashimoto's disease. Complaints of achy body, upset stomach, congestion, warm to touch, and sore throat. Patient states she has become more sensitive to colder temperatures, with 70 degrees being cool to her. Patient states she is being seen by an endocrinologist that has since diagnosed her with Grave's disease and has been given a medication regimen to follow accordingly. Patient has not received her Covid-19 vaccine booster.
11:05 reported feeling funny, site of shot inc redness;BP 168/92, 108, 26;11:10 adrenalin given BP 174/94, 116, 28;11:13 02 given c/o nausea;11:15 174/94, 104, 24;wheezing;tired;
the patient was administered an improperly stored dose of PNEUMOVAX 23; No adverse effects; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant drugs were not reported.  On 31-MAR-2019, the patient was vaccinated with improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 1 vial, intramuscularly, lot number R022754, expiration date 17-JUL-2020 (site of administration was not reported) for prophylaxis. The administered vaccine was stored in temperature of 66.9 Fahrenheit degrees (F) for 8.5 hours. Digital data logger was involved. No previous temperature excursion was provided. No adverse effects were reported.
Arm felt tingly right away. Within 5 minutes chin felt numb. Within 2 hours left side of face was tingly and numblike.
Initial consumer report received on 17 Dec 2009: This patient received Fluvirin on an unspecified date. On 16 Nov 2009, she experienced an allergic reaction after receiving the vaccine. She experienced a "real bad rash, shortness of breath, dizziness and nausea". The patient did not seek medical attention. The events recovered on the same day (4 hours later).
This spontaneous report was received from a medical assistant concerning a 13-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 09-JAN-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot number: L016429, expiration date: 09-AUG-2017, dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
irritation; itching; swelling/bumps/bumps stay for 30 min and it dissapears/Within a few minutes, it reappears in another place; allergic reaction; hives/line of hives/stripes/hives in her back, stomach, armpit, hips and chest.; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives/line of hives/stripes/hives in her back, stomach, armpit, hips and chest.), SKIN IRRITATION (irritation), PRURITUS (itching), SWELLING (swelling/bumps/bumps stay for 30 min and it dissapears/Within a few minutes, it reappears in another place) and HYPERSENSITIVITY (allergic reaction) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 045A21A and 041A20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (hives/line of hives/stripes/hives in her back, stomach, armpit, hips and chest.). On an unknown date, the patient experienced SKIN IRRITATION (irritation), PRURITUS (itching), SWELLING (swelling/bumps/bumps stay for 30 min and it dissapears/Within a few minutes, it reappears in another place) and HYPERSENSITIVITY (allergic reaction). At the time of the report, URTICARIA (hives/line of hives/stripes/hives in her back, stomach, armpit, hips and chest.) had not resolved and SKIN IRRITATION (irritation), PRURITUS (itching), SWELLING (swelling/bumps/bumps stay for 30 min and it dissapears/Within a few minutes, it reappears in another place) and HYPERSENSITIVITY (allergic reaction) outcome was unknown.            No concomitant medication was reported.  The patient went to the doctor which prescribed antihistamine and made the hives subside. However, if patient goes one day without medicine, the hives reappear.Patient's husband mentioned that he searched the medical condition and it is called dermatographic urticaria.  Treatment medication included antihistamine.   This case was linked to MOD-2022-481849 (Patient Link).
warm, prickly sensation all over body;no rash, itching, welts, SOB;no treatment given lasts 3hr p/vax;
Patient was given expired (4/4/2022) pediatric Pfizer vaccine. Vial was removed from the refrigerator without looking at the expiration date on the box.  The vaccine was diluted per manufacture directions. Dose was drawn up in the syringe and administered to the patient.  The patient experienced no adverse reaction.  Manufacturer was called to instruct our facility what the next steps are.
Higher than normal blood pressure; This is a spontaneous report from a contactable consumer, the patient. This 89 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown),  dose  1 , single dose via an unspecified route of administration in the right arm on 21Jan2021 at 12:00 PM (at the age of 89 years-old) for COVID-19 vaccination. The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history was unknown. Concomitant medications were not reported. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. On 21Jan2021, the patient experienced higher than normal blood pressure. The event, higher than normal blood pressure was reported as non-serious. There was no treatment received for the event. The clinical outcome of higher than normal blood pressure was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
I got the dose at 7PM on February 6. Around 5AM, I felt really tired and went home as I was at work. I took Tylenol and I woke up the next day and I felt very dehydrated. I drank a lot of water and got my uniform from the dryer. I woke up and I had passed out in the laundry room. I have intense pain from my menstruation and would pass out in the past due to it, but it wasn't like that because I had no warning signs. I had to call out and I had to call a friend to stay with me for a little bit. After I ate, I felt dizzy and slept after sleeping for 4 hours. The next day work asked if I could work, I said yes. I went to work and after 4 hours, I asked to go home because I wasn't feeling well and rested the entire day. I went to the ED because they said I had to get checked. I worked in a COVID floor and they said I couldn't have this reaction. I got a CT scan among everything else, and they told me to not get the second dose if you got a severe adverse reaction, so I am not getting the second dose. I felt sick again when I went back to vacation in June. I had to get tested for COVID and they came back negative.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of the patient was 35.84. On 27-Feb-2021, Excursion time was 09 AM, temperature was 32, total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-febr-2021. 14 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.  On 31-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 33, 10 AM: 36, 11 AM: 35, 12 AM: 35, 1PM: 35, 2 PM: 35, 3 PM: 34, 4 PM: 34 and 5 PM: 35.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
After receiving her 2nd dose of the Moderna COVID-19 vaccine, approx. 1 hour later she complained of a tingling and numbing feeling at the back of her tongue on the left side.  She denied any difficulty breathing or eating.  She denied any shortness of breath or acute respiratory distress.
Patient complaint of extreme metal taste in mouth and burning on tongue.   25 mg of Benadryl po given.  Pt. waited 30 minutes after Benadryl and released by Dr. via telephone.
mom reports p/1st dose 27APR93 @ 1030AM pt was OK until 230PM cried & was fussy mos of the time; did not nurse well; no change in cry; mom reports legs very sore-one w/lump & reddness size golf ball; would quiet down but  any movement of l;
Moderna COVID-19 Vaccine EUA: patient hospitalized for chest wall pain and COVID-19 pneumonia with possible bacterial pneumonia. Administered remdesivir, steroids, and antibiotics. Patient improved and discharged to home medically stable.
This spontaneous report was received from a nurse referring to unspecified number of patents of unknown age and gender. No information regarding patients' medical history, concurrent conditions and concomitant medications were provided. On an unknown dates starting on or after 02-JUL-2016, the patients were vaccinated with improperly stored doses of ROTATEQ (dose, route, lot # and expiry date not reported). The vaccine was exposed to temperature of 32.4 degree Fahrenheit for 95 hour. No previous temperature excursion and no adverse effects were reported. The call was not due to data logger. This is one of several reports received from the same reporter. Additional information has been requested.
Narrative: Patient contacted triage line due to 3 days of fever, chills, swollen/itchy arm, headache (different than migraines) and extreme fatigue. Symptoms developed a few hours after receiving 2nd Moderna vacccine. Patient felt tired after the first vaccine, but felt well by 2nd day. Arm described as hot to touch, baseball size area of redness around injection site. No red streaks. No difficulty breathing or swelling of face, lips or tongue. Provider completed telehealth visit. Observed well demarcated erythema inferior to shoulder joint extending over bicep, redness and swelling. Large local inflammatory reaction. Recommended to continue anti-inflammatory therapy.
MODERNA VACCINE #3 GIVEN 11/11/2021, LOT #071F21A. MODERNA VACCINE #4 GIVEN 05/04/2022, LOT #056A22A. 6/5/22 pt transferred to hospital from outside hospital due to elevated troponin; pt also had a positive COVID test without any respiratory sx; no O2 supplement needed; treated with Vitamin Supplements; EKG showed right BBB; dx with NSTEMI; pt did not want any aggressive or invasive tx, would pursue medical management only; dc'd 6/8/22 to the Nursing home where she passed away on 6/28/22
No additional AE; Caller reports the administration of expired VAQTA; Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 20-JAN-2021, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated(VAQTA) (administration route and anatomical location were not reported) lot # S036494, expiration date on 09-JAN-2021, 1 milliliter for prophylaxis. The reporting nurse stated the administration of expired hepatitis a vaccine, inactivated(VAQTA) and inquiring information if administration of vaccine was viable. No additional adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036494; expirationdate: 09-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Itching at the back of head, arms and legs; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching at the back of head, arms and legs) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced PRURITUS (Itching at the back of head, arms and legs). At the time of the report, PRURITUS (Itching at the back of head, arms and legs) outcome was unknown. Not Provided          Reporter did not allow further contact
This spontaneous report was received from a other healthcare worker refers to a 9 month old patient of unknown demography. On an unknown, date the 9 month old patient was vaccinated with VAQTA 50/1.0 U/ML (dose, route and frequency were not reported). No further information was provided. Additional information has been requested.
CNS demyelinating  disease (unclear if this is the first symptom of multiple sclerosis)   He originally presented with progressive weakness over 3 years which reportedly started on 2/4/21  The first symptom was actually vertigo for about 10 days followed by slurred speech and imbalance which occurred after 2/17/22  MRI brain 2/23/22 showed enhancing lesions in the right middle cerebellar peduncle  Brain biopsy was consistent with possible demyelinating disease  He was treated with IV solumedrol x 5 days completed 4/4/22 and he actually had a steroid-induced diabetic symptoms with blood sugars > 1000  MRI brain revealed lesions in the left middle cerebellar peduncle, R pons , both of which were enhancing  MRI spectroscopy revealed choline elevation and decreased creatinine  MRI spine showed no demyelinating disease  He had some improvement of left sided weakness but is having frequent left sided muscle spasm
After Proquad given family noted small redness at injection site. MD called and evaluated, no infection, suspected mild local reaction about dime size. 2 days later called by parent, concerned redness swelling, wanted report made to VAERS. No fever, able to move arm, no other symptoms except maybe a mild cough.
Fainted and fell face first  on my kitchen floor out for about 2 minutes.  Bruised face.
rash on arm where given PPD, itches;no SOB, dyspnea;
pt recv vax 31JAN97 & on 3FEB97 pt exp a gen rash;
Fevers to 102.7, chills, rigor, redness, pain and erythema at site of injection, leukocytosis of 23,000 noted in ER, diagnosed with cellulitis, started on antibiotics, blood cultures negative thus far.
Patient was vaccinated 2/25/21, pt then went through a mass clinic and received his second vaccine on 3/1/8/21, a week earlier then recommended.
Pain in the muscle, upper arm; itchy arm; soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness), PRURITUS (itchy arm) and MYALGIA (Pain in the muscle, upper arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN (soreness). On 17-Feb-2021, the patient experienced PRURITUS (itchy arm). On an unknown date, the patient experienced MYALGIA (Pain in the muscle, upper arm). At the time of the report, PAIN (soreness), PRURITUS (itchy arm) and MYALGIA (Pain in the muscle, upper arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient presented to clinic and requested RSV vaccine be given. Provider educated patient that this vaccine is recommended beginning at age 60. She also clarified that patient does not have a immunocompromised status. Despite this information, patient insisted on vaccine being administered outside of CDC and guidelines.  No known adverse reaction.
Received 1st dose Pfizer COVID vaccine 9/8/2021. Pt reported sore arm for 2 days post injection and then  pain subsided. Awoke on the morning of 9/16/2021 with very swollen right arm at injection site and pain radiating to right neck,.