chrisvoncsefalvay/vaers-outcomes huggingface dataset:
he had some pink spots underneath the band-aid on the injection site; the area got very itchy and real hot (felt like he have a fever on the arm); the area got very itchy and real hot (felt like he have a fever on the arm); weakness; tiredness; headache; some pressure on the administration site up to his ear; having some pink spot like a rash its like a little itchy but I haven't scratched; It was real real hot but its warm now; it was before it was inflamed, it was like real hot and it was pink but it's still pink but it's not as hot as it was before; This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), via an unspecified route of administration on 01Jun2021 (Batch/Lot Number: EW0187) as Unknow, 0.3ml Single for COVID-19 immunization. The patient also received Lisinopril via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 10mg once a day for hypertension. Medical history included Arthritis, Blood Pressure and Overweight. Concomitant medication included Celecoxib twice a day 200mg tablet for arthritis and Chlorthalidone 25 mg for High Blood Pressure. On an unspecified date, the patient received Pfizer Injection morning around 10:00 and now he was having under the injection site in the shoulder, he was having some pink spot like a rash it's like a little itchy but he hadn't scratched it he did put some camphor lotion and then wipe the excess of it all and now its itchy and now it's warm so, he put cold press on it with ice and it comes down a little bit and he took Acetaminophen. The patient did not know if he did something wrong but he did not want to damage the vaccine. The patient was bit of pressure and little bit of tired. He tried to water and anything if it's okay just stay there that's is and if it's okay it's just there. The patient did not feel anything else bad in the body or anything like that. it's a little worm now but it's gone down a little bit. It's not bad like it was before it was inflamed. In the afternoon (about 20-30 mins ago) the area got very itchy and real hot (felt like he has a fever on the arm). The patient did not receive any other vaccine within 4 weeks prior to Covid vaccine. The outcome of the events was unknown.  Follow-up attempts are possible. Further information is expected.
Cellulitis 3x2 cm indurated, increased warmth @ area of varicella vaccination.
Day 8 an itchy arm at injection site.  Day 9 red and itchy at vaccine site,  slightly swollen
Patient had relatively normal adverse reactions but pain with movement in left arm at injection site has persisted until now. Patient feels that it is not normal that the pain is still an issue.
14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date).    No concomitant medicine were reported. No patients have been administered monovalent vaccine after the beyond use date.  Doses were administered from 8-Dec-2022 to 10-Jan-2023. No treatment medicine were reported. This case was for 6th out of 14 patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-703586 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-703586: case - 1st adult
Dizziness; Tenderness at the injection site; This is a spontaneous report from a contactable consumer (patient) via Pfizer Support. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on an unspecified date in Apr2021 (reported as yesterday) as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated, he went to work, everything was good, but towards the end of the night (as per report) he started experiencing tenderness at the injection site. In morning he woke up and was dizzy, in which he was still experiencing dizziness, but it was manageable. Patient pulse was good, and he has not checked his blood pressure. The outcome of the event dizziness was not recovered and for tenderness at the injection site was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patients received expired Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received expired Moderna COVID-19 vaccine) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received expired Moderna COVID-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received expired Moderna COVID-19 vaccine) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. The vials were initially stored in refrigerator on 04-Apr-2022. The vial did not undergo temperature excursion. It was reported that the pharmacist thought that the expiry date of the vaccine was Jun-2022, However the vaccine expired on 01-Apr-2022. No treatment medication was provided.
Monday she had the Covid-19 booster on left upper arm. Started with redness and itchy arm on Tuesday. Yesterday redness was worse and arm is hard and hot to the touch. It is not worse since yesterday but not better.
Joint pain all over body (ankles, hips etc) that started after vaccination. Symptoms have not improved since receiving shot.
Guillain-Barre Syndrome, in intensive care on a ventilator for a month; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was not recovered/not resolved.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 02-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got Guillain-Barre Syndrome shortly after a shingles vaccine. The patient was in intensive care on a ventilator for a month and in rehab for another 2 months and stated was one of the lucky ones. Still suffering effects after 5 years. Additional Supportive Information: Follow-up would not possible as no contact details were available.
I have exercise induced asthma but rarely have asthma attacks.  I started getting frequent asthma attacks about 3 weeks after my second Moderna vaccine.  They did not respond to my albuterol inhaler and started becoming more frequent.  I had to start on steroids in order to get the attacks under control.  I also had asthma attacks following my moderna booster in December.
rash at the injection site; soreness at the injection arm; swollenness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (soreness at the injection arm), INJECTION SITE SWELLING (swollenness at the injection site) and INJECTION SITE RASH (rash at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 6381C20A) for COVID-19 vaccination.     The patient's past medical history included High cholesterol, Kidney absent and Hyperthyroidism. Concomitant products included SERTRALINE for Anxious depression, EVOLOCUMAB (REPATHA) for High cholesterol, AMLODIPINE and RAMIPRIL for Kidney disorder, LEVOTHYROXINE for Thyroid disorder.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 09-Feb-2021, the patient experienced INJECTION SITE PAIN (soreness at the injection arm) and INJECTION SITE SWELLING (swollenness at the injection site). On 12-Feb-2021, the patient experienced INJECTION SITE RASH (rash at the injection site). At the time of the report, INJECTION SITE PAIN (soreness at the injection arm) and INJECTION SITE SWELLING (swollenness at the injection site) had resolved and INJECTION SITE RASH (rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: ADR form
After vaccination it was determined that only 14 days had passed since the first dose. Per Agency website vaccination does not need to be repeated but to complete AGENCY as vaccine administration error. Patient is doing fine and is aware of the recommendation.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. 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, and batch number were not reported, expiry date: unknown) dose was not reported, 1 total administered on 21-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, patient experienced really bad cold. On 04-JAN-2022, the patient tested positive for covid (confirmed clinical vaccination failure, and confirmed covid-19 infection). Laboratory data included: COVID-19 virus test (NR: not provided) Positive.  Patients antibodies were also tested. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) 489. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked. This report was associated with a product quality complaint.; Sender's Comments: V0: 20220228007-COVID-19 VACCINE AD26.COV2.S-confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
elevated temperature, 99.7, 100.4, headache nausea, arm - ok
Facial numbness and prickling for couple of minutes on4/1/21. Woke up with facial numbness on 4/2/21 and later in the day felt the roof of my mouth and portions of my tongue felt numb. Continued till 4/4/21 where in only my forehead and around my mouth felt numb and prickly.  Then it has been on and off till date
red welts on her arm/weird rash with welts that looked like drip marks; broke out in weird rash/weird rash with welts that looked like drip marks; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced red welts on her arm/weird rash with welts that looked like drip marks and broke out in weird rash/weird rash with welts that looked like drip marks on an unspecified date. It was reported that about to get the 2nd dose of the Pfizer covid vaccine. After the first dose she broke out in weird rash, red welts on her arm. She told the pharmacist that and they told her to call Pfizer. broke out into weird rash with welts that looked like drip marks. She had side effects with the first one. She broke out into a weird rash, with bright red giant welts that looked like drip marks. They looked like drip marks and were on the same arm as the vaccine was given. The outcome of the events was unknown.   Follow-up (19Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
No further information provided, no additional adverse effect reported; temperature excursion for VAQTA that was administered to three different patients; This spontaneous report was received from a nurse and refers to a 15-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 30-JUL-2021, the patient was vaccinated with improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) 0.5 mL, lot # T023913, expiration date 31-MAR-2022 (route of administration and anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced excursion of 11.1 degrees Celsius for 1 hour and 17 minutes. There was no previous excursion reported. Digital data logger was involved. There was no additional adverse event reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T023913; expirationdate: 31-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2108USA000554: US-009507513-2108USA000581:
Sudden rash and red welts all over body and worsening on arms, spreading across face and legs.
Pneumovax injection yesterday 30 min after receiving started itching. C/O soreness and warmth. No change since onset. Tx with cool compresses, triamcinolone cream 0.1% tid and Zyrtec 10 mg q day. Initially area red, warm L deltoid 5 1/2" x 6 1/2" not subsided by 3-20-06.
mom called on 21NOV94; pt has weakness, swollen glands, orchitis, dizziness, aching muscles & joints & malaise; advised to see MD today; 21NOV94 mom called back p/seeing MD who felt not due to vax poss strept throat or mono;
I haven't had a menstrual cycle after I received my second dose. Also, I've had severe hot flashes .
The day of the second dose and the subsequent day I had severe chills, extreme fatigue, and headache as main symptoms.  I also had an enlarge lymph node under the left armpit.  Then on 10/02/21 I had a cotton wool spot on my left eye, and now a month in it is improving but not gone.  I saw an optometrist who saw that small bleeding in the eye and then I saw an ophthalmologist, who confirmed this and named it as a cotton wool spot.
Skin redness/rash only on left side of body. Skin swelling, mildly itchy and hypersensitive. Started 4-18-13 pt had appt with Dr. on 4-18-13. Dr. prescribed Valacyclovir 1 gm: 1 every 8 hrs x 7 days.
(L) leg swollen, loss of thigh crease x 2 months. First day she wouldn't walk on it was very swollen, but not red. She had possible there. Mom said she had possible mild fever first day.
Immunization expired 4/1/23 and was administered on  4/3/23
Within 4 hours of receiving imunization at 6 weeks pt's left thigh became red and swollen. He became very irritable this persisted about 24 hrs.
Employee received the first dose of the COVID 19 vaccine on 1/22/2021 in her left deltoid. At the time she received the first dose she only had a sore left arm. Two days after receiving the vaccine she experienced shooting, sharp pain when she tried to lift her left arm forward or to the side. Pain was 8 out of 10. She saw her primary care doctor, on 2/1/21. He advised her to wait to see if the symptoms got better. She continued to have decreased range of motion and shooting, sharp pain when she moved her left arm. She saw an orthopedic doctor on 2/10/2021 who did an x-ray and MRI. The MRI showed calcification of the bursa in her left shoulder. This doctor recommended cortisone injections. Employee received the first dose of the COVID 19 vaccine on 1/22/2021 in her left deltoid. At the time she received the first dose she only had a sore left arm. Two days after receiving the vaccine she experienced shooting, sharp pain when she tried to lift her left arm forward or to the side. Pain was 8 out of 10. She saw her primary care doctor,  on 2/1/21. He advised her to wait to see if the symptoms got better. She continued to have decreased range of motion and shooting, sharp pain when she moved her left arm. She saw an orthopedic doctor on 2/10/2021 who did an x-ray and MRI. The MRI showed calcification of the bursa in her left shoulder. This doctor recommended cortisone injections, but the employee did not want to do that. On 3/10/2021 she saw an orthopedic surgeon who specializes in shoulders. Drtold the employee she had a shoulder injury related to vaccine administration (SIRVA) because the needle from the COVID 19 vaccine went into the bursa sac in her left shoulder. He is recommending physical therapy for treatment. Employee reports currently the shooting, sharp pain is gone and now there is a dull ache in her shoulder. The employee states she received the second COVID vaccine, with a smaller needle, with no adverse effects.
LIGHTHEADEDNESS, NAUSEA AT ONSET, THEN PROGRESSED INTO HEADACHE WITH VOMITING APPROX 6 HOURS LATER. VR 02/11/2014.
red rash  at injection site; injection site itchy; injection site bright red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE ERYTHEMA (injection site bright red) and VACCINATION SITE RASH (red rash  at injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced VACCINATION SITE PRURITUS (injection site itchy) and VACCINATION SITE ERYTHEMA (injection site bright red). On an unknown date, the patient experienced VACCINATION SITE RASH (red rash  at injection site). At the time of the report, VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE ERYTHEMA (injection site bright red) and VACCINATION SITE RASH (red rash  at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Additional  information includes address and event (very red rash) were added. On 26-Jul-2021: Non-significant follow-up appended.
After the vaccine, Dec 6th (within 24 hrs),  there was sever itching on skin surface.  After a few days the itching turned to a rash condition.  Not specific on exact timing for initial rash.    The Rash developed into open sores with deep nerve pain.    Went back to the doctor on Dec 17th and was diagnosed that this was shingles.  The rash in close proximity to left arm, where shot was given.  it extended from middle of back, under arm pit and on left side of chest.
Patient developed chills, no fever at 8pm 10/31/18, felt very cold. The next morning her ear hurts, with major headache, body ache and severe nausea. She called the pharmacy at 10:20 am to report events after vaccine received from previous day. Patient is resting at home.
pt recv vax 4DEC97 & w/in 4hr of vax pt exp gen hives & was brought back to the facility where was vaccinated;
Pt experienced anaphylatic reaction (throat swelling/difficulty breathing).  Reaction started about 45min to 1 hour after vaccination.  Patient also had drop in blood pressure.
101 F fever and he felt worst on 26Mar2021; has presented general malaise/feeling unwell; fatigue; This is a spontaneous report from a contactable consumer reported for self. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 24Mar2021 as single dose for COVID-19 immunization. The patient's medical history included COVID-19, exposed to the virus/COVID-19 from 25Mar2021 and ongoing. Concomitant medications were not reported. The patient received the first dose of the COVID-19 vaccine on 24Mar2021 (Wednesday), he had been feeling unwell for two days, on 25Mar2021 and on 26Mar2021, he presented a 101 F fever and he felt worst on 26Mar2021, he recently became aware that he was exposed to the virus on 25Mar2021, apart from the fever he had presented general malaise and fatigue. During the call he mentioned that he felt similarly to when he was diagnosed with COVID-19, he was not sure if he had contracted the infection once again. Outcome of the events was unknown. The case was reported as non-serious.  Information on the lot/batch number has been requested.
patient had flu shot on 10-14-19 --patient states a day or 2 later her arm became itchy and she started scratching it.  A large area on her arm became black and blue--it extended from the shot down to the elbow.  I advised her to call her doctor to let them know what happened and I advised her she should be seen by physician today.
started screaming & crying about 2PM on 31JAN93; about 4PM noted thighs & leg beefy red & burnt looking; called MD was told to give DPH & come to ER; p/45 mins of taking DPH rash looked better; t100.0;