chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Dec2022) positive, notes: symptoms returned and I tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Inappropriate age at vaccine administration; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 012L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). On 17-Feb-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.    This case was linked to MOD-2021-013640 (Patient Link).
administration of expired Fluarix vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 953Y2, expiry date 30-JUN-2023) for prophylaxis.   On 12-SEP-2023, the patient received Fluarix Quadrivalent 2022-2023 season. On 12-SEP-2023, an unknown time after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced expired vaccine used (Verbatim: administration of expired Fluarix vaccine).  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: GSK Receipt Date: 12-SEP-2023    The pharmacist reported the administration of expired Fluarix vaccine to patient who was administered 2022-2023 Fluarix instead of Fluarix for 2023-2024 which led to expired vaccine used. The reporter consented to follow up. This case was one of 9 cases, reported by same reporter.
Patient states rash and hives occurred later in the evening after receiving an influenza shot.  The rash has continued into the morning.  Patient did take bendaryl and it seemed to help.  The pharmacist instructed the patient to contact their primary care provider.
Red, itchy bump a week after shot. Redness spread towards elbow. No pain. Redness and swelling lasting for 5 days so far
croupy cough, non-productive, aches, inc temp, bruising, swollen hot area arm size of grapefruit;SOB w/walking;also itching;
Swelling, hematoma (Rt) thigh with 1x1.5cm with puckering of skin overlying it.
about 1 hour after the vaccine he complained about his neck hurting then it turned into a stiff neck. by 7pm on the same day he started having chills and stated he was freezing. then we began to monitor him. around 10 pm he had a fever of 101.7. I gave him an Alker Seltzer and asked him if he wanted to go to the emergency room he said no. around midnight he started complaining his entire body ached and his neck was hurting. This all happened within 24 hours of taking the shot. his temperature when down in the morning but still complaints of body and neck pain for at least 5 more days.
I believe patient got the vaccinations sometime in the morning. Even though he never napped, he was very lethargic all afternoon and fell asleep on the couch.  Around 4:00, when my mom and I tried to rouse him, his eyes rolled back into his and he became stiff (arms, legs, and trunk). This only lasted for a few seconds (maybe 5?), but it was scary. He was also not very coherent and not responding well when I talked to him. He did not want any dinner. We put him to bed around 6 pm. After talking to my pediatrician, we woke him up and took him to the pediatric urgent care type office, as per her recommendation. The doctor there examined him.
She had bacterial vaginosis around 7/9/2021 that required two rounds of oral antibiotics. It was pretty severe. It took about a month to clear up. There was no other reason for her to have it. She is not sexually active and has had no STI's. She had a resurgence of it in 10/2021, but we caught it early. It started after she got a cold. That time it was treated with just one round of antibiotics.
severe muscle weakness & pain to upper extremities; no strength in both hands; couldn't lift anything-couldn't dress self-couldn't drive;
Painful arm x 4 days-1st shot Body aches, lethargy x 2 days-2nd shot
Narrative: Headache, Myalgia, Arthralgia, Fever, Fatigue, Chills.
episode of pain in her pelvic area on both the right and left side all of a sudden; This spontaneous case was reported by a consumer and describes the occurrence of PELVIC PAIN (episode of pain in her pelvic area on both the right and left side all of a sudden) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Dehydration (Medical history reported as patient had dehydration in the past.).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced PELVIC PAIN (episode of pain in her pelvic area on both the right and left side all of a sudden). At the time of the report, PELVIC PAIN (episode of pain in her pelvic area on both the right and left side all of a sudden) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment included drinking water.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the event a causal relationship cannot be excluded.
Patient reported nausea and headache within 15 minutes of vaccination.  She then developed itchiness in her mouth and ears and was given Benedryl.  She developed hives on her scalp and was given epi.  Patient was transported to ER by EMS.
Patient presents for 2nd Moderna Covid-19 vaccine.  Epic alert showed patient had completed series.  Chart shows that patient received Janssen Covid-19 vaccine on 4/9/21.  Received Moderna Covid-19 vaccine on 4/27/21.  Patient did not inform us at that time that he had received the Janssen.  He said he got the Janssen at work but then heard that the Moderna was "better" so he scheuled to receive that.  He had covid back in October and still does not have his taste or smell and he had heard that if he got the moderna it would come back sooner.  Discussed with the patient that he was fully vaccinated with the Janssen and that we would not be giving him his 2nd Moderna today.  He understands.
Vaccines administered after being in stored in fridge past 30 days; Vaccines administered after being in stored in fridge past 30 days; Patient received Moderna bivalent vaccine as First dose; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient received Moderna bivalent vaccine as First dose) and NO ADVERSE EVENT (no adverse event) in a 72-year-old 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. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient received Moderna bivalent vaccine as First dose) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient received Moderna bivalent vaccine as First dose) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and WRONG PRODUCT ADMINISTERED (Patient received Moderna bivalent vaccine as First dose).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-730541 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730541:Same Reporter
Patient is nontoxic-appearing 70-year-old female with a history of coronary artery disease and CHF with a LifeVest on and recent heart catheterization at the end of November with patent vessels and a EF of 20 to 25% presents the emergency department ambulatory for shortness of breath.  Patient states that is gotten worse over the last 24 hours.  She denies any productive cough.  She has no leg swelling however states that she normally does not get leg swelling whenever she puts on water weight.  Yesterday she weighed 170 pounds this morning she was 178.  Denies any chest pain.  No fevers. Associated Symptoms: orthopnea, paraoxysmal nocturnal dyspnea, shortness of breath
Severe chills without fever, extreme fatigue, 12 hours sleep, 24 hours joint  head ache, loss of appetite for 24 hours, 48+ hours inflammation and redness at inection site.
Headache, Sedation, Myalgia, Arthralgia & Phlebitis  Narrative:
Patient taken to School Nurse's office 10/30/09: with c/o's of dizziness, and itching to arms.  Dr. was consulted.  Pt offered Benadryl 50mg po, but patient refused;  Taken to ER by parent. 11/02/09 Report by School Nurse)- patient was seen in the ER on 10/30/09, and released.  No further problems.
Case number PHHY2011US44949, is an initial report from a nurse received on 25 May 2011. This report refers to a 14-year-old female patient. The patient was vaccinated with MENVEO (batch number unknown) on 22 Apr 2011. Only Men ACY 135 component administered to the patient. No other information was reported.
pt recvd vax; hives, malaise, redness & swelling at site 4feb93; tx w/ dph; 5feb93 tx w/ prednisone x 4 days;
Booster.  Started having strong muscle aches and feeling feverish - though no temperature registered around lunch time. Symptoms persisted through the day and night, giving some relief with Tylenol/Advil.  Had strong night sweats and trouble sleeping that evening. Still feeling feverish today.
Patient received a flu vaccine, stood up to quick and experienced a vasovagal syncope incident.  Patient fell backwards, was assessed by Nursing personnel and EMS - was alert and responsive
Flu like symptoms: A pt received RabAvert for 4 doses and experienced flu like symptoms, local reactions which became more intense after each dose. After the 4th dose there was redness and swelling that measured about 2" in diameter. Follow up information is pending.
The 1st. shot, slight headache and sore arm.  2nd shot I immediately had headache, sore muscles, chills and slight fever.  Approximately two weeks later I could not breathe.   then I saw the news where Johnson N Johnson had given blood clots to some patients.  I saw the sysmtoms and i realized I had those sysptoms.  i didnt go to the doctors until i got worst July 13,2021 and found out I had a blood clots in my lungs.
Patient states muscular pain when lifting arm after receiving flu shot. States he was unable to lift arm above head for about 1 week following receiving flu shot. About 2 weeks after shot, patient came into the pharmacy and states that arm is still sore. I looked at the area and it was not red or swollen.  He is now able to lift arm above head but states the area is still sore.
received prevnar 20 and it has white flakes and is cloudy; received prevnar 20 and it has white flakes and is cloudy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received pneumococcal 20-valent conjugate vaccine (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT PHYSICAL ISSUE (non-serious) and all described as "received prevnar 20 and it has white flakes and is cloudy".  The reporter considered "received prevnar 20 and it has white flakes and is cloudy" associated to pneumococcal 20-val conj vac (dipht CRM197 protein).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The day after receiving the booster, I had intense chest pain and was hospitalized; no signs of myocarditis or pericarditis, and was discharged that evening. On Friday, Feburary 4th (4 days after receiving the booster) I began experiencing intense left arm pain precisely where the booster shot was administered ( 4 on a scale of 1-10). This was followed by rather visible, pronounced fasciculations in shoulders, legs, and arms (recently, the muscle spasms have started to wane). A week later, I began developing severe muscle cramping, stifness, and arthritic pain in both shoulders and upper back. The cramping, shoulder and muscle pain are ongoing. The latest symptom is joint pain. I also have reduced mobility in my right and left shoulders not related to exercise.   a 6-day course of Methyprendisolone was given with little relief
Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles 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 shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-SEP-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The reporter reported that he/she had Shingles twice once he was 16 years old and when he/she was much older. The reporter stated that he/she did not want to receive shot because he/she knewpeople that received Shingles vaccine and right after they experienced Shingles. Additional supportive information: This case had been linked with US2022AMR132562 and US2022AMR132557 reported by same reporter for different patient. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR132562:Same reporter US-GSK-US2022AMR132557:Same reporter
I was at home in March and I was unable to breath. I was unable to catch my breath. Someone called the ambulance and I was admitted to the hospital for more than a week. I was admitted to Health for more than a week. It was determined I was having heart failure. I was administered medications via iv and was released. I was given Brilinta and eventually released. My surgery was delayed because I ended up catching COVID. The surgeon decided to wait a few months since I was on a ventilator. I was hospitalized again on the 20th of December and had my surgery on the 29th. I am still having shortness of breath and having to take Lasik's for fluid retention. I am also on oxygen. It was initially for night time use but now its as needed which is all the time. I spent at least 30 days in and out of the hospital.
Myalgia, Arthralgia, Fever,  injection site pain, chills Employee reports injection site pain/discomfort, fever, chills, joint pain, and body aches approximately 8 hours after receiving the vaccine. All symptoms have resolved since. Reports took Tylenol four times to help with pain/fever.
pt recvd vax & 23MAY93 following 2nd inject exp fifth disease (erythema infectiosum); pt was seen by MD; did not receive treatment; sx have not subsided;
Starting 2 approximately two weeks after second shot -  Tingling and sharp pain throughout pain. Feels like "nerve pain".  Is not consistent in any one location and varies of the severity. Is not related to shot location.
there are 250 reported cases of similar reaction - Guillain Barre Syndrome - after taking Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (there are 250 reported cases of similar reaction - Guillain Barre Syndrome - after taking Moderna vaccine) 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)) 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)) (unknown route) 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (there are 250 reported cases of similar reaction - Guillain Barre Syndrome - after taking Moderna vaccine) (seriousness criterion medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (there are 250 reported cases of similar reaction - Guillain Barre Syndrome - after taking Moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       Concomitant medication was not reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment medication was not reported.  Company Comment: This is a Spontaneous case reported by a consumer, concerning an adult patient of unknown gender, with no medical history reported, who experienced the unexpected and serious (due to medically significant) AESI of Guillain-Barre syndrome, which occurred on an unknown date related to an unspecified dose of mRNA-1273.222 vaccine. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA- 1273.222 vaccine is not affected by this report.     This case was linked to US-MODERNATX, INC.-MOD-2022-692416 (Linked Report).; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning an adult patient of unknown gender, with no medical history reported, who experienced the unexpected and serious (due to medically significant) AESI of Guillain-Barre syndrome, which occurred on an unknown date related to an unspecified dose of mRNA-1273.222 vaccine. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA- 1273.222 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-692416:master case
Within 90 minutes of injection, was flushed, headache, body aches, nausea.
I had a few things happen after having gotten the shots. I had a softball-sized red spot on my injection site. It itched like crazy and i had muscle aches. After the 2nd shot, I started getting short of breath out of no place. I feel like I can't breathe randomly throughout the day.
Next day pain all over my body headache swelling of lymph node behind my neck and armpit and throat swollen and hard to swallow hard to breathe.. Fourth day pain on my body was gone but headache lymph nodes swelling in the back of my neck armpit constant severe headache doesn't go away with medication Excedrin and aspirin. Can't sleep pain is intense. Feels like my head is swollen started experiencing chest pain that lasted for about a month or two. Trouble concentrating. Tired lethargic.
Resident c/o dyspnea, lethargy, and "not feeling well". Sent out to ER. No other symptoms noted.
Shortness of breath, cough, dyspnea on exertion, tachycardia and verified acidosis found by blood test.  Symptoms started two weeks after shot administered, with mild shortness of breath, cough and progressed to respiratory acidosis.  Patient was treated with Prednisone.  Still some residual shortness of breath with exertion.
patient received the Johnson and Johnson Covid-19 Vaccine instead of getting the second dose of the Moderna Covid-19 Vaccine.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (patient received the Johnson and Johnson Covid-19 Vaccine instead of getting the second dose of the Moderna Covid-19 Vaccine.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Non-Moderna Manufacturer) 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) dosage form. On 28-May-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (patient received the Johnson and Johnson Covid-19 Vaccine instead of getting the second dose of the Moderna Covid-19 Vaccine.). At the time of the report, PRODUCT ADMINISTRATION ERROR (patient received the Johnson and Johnson Covid-19 Vaccine instead of getting the second dose of the Moderna Covid-19 Vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact