chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse practitioner student refers to herself of unknown age. The nurse was received dose of an unspecified RECOMBIVAX HB on the following date: on 27-FEB-2004 (lot # LNG5379A4, exp date 13-MAY-2004), 02-APR-2004 (lot # ENGI507A4, exp date 14-FEB-2005), and 11-OCT-2004 (lot # EWGI589A4, exp date 15-SEP-2005). She was tested "last week" for hepatitis B titers because she was going to be starting her clinical rotation, and she was negative for immunity to hepatitis B. She stated that she has not experienced any other adverse effects. She did not want to provide her physician's information, but she stated that she can be contacted for additional information. The outcome of negative for immunity to hepatitis b was unknown. Additional information has been requested.
I first saw patient 10/29/2018, but retrospectively, the infant developed diarrhea within a few days of ROTATEQ and bloody, mucousy diarrhea and lethargy 5 days after ROTATEQ. Bloody stools resolved the same day as they developed and loose stools resolved within a couple days.
LETHARGIC (FATIGUED,VERY TIRED,UNABLE TO GET OUT OF BED); WINDED  FROM WALKING AND RUNNING; PERIOD DELAYED BY TWO WEEKS; This spontaneous report received from a consumer concerned a 42 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced period delayed by two weeks. On 26-APR-2021, the subject experienced lethargic (fatigued/ very tired/ unable to get out of bed). On 26-APR-2021, the subject experienced winded from walking and running. The action taken with covid-19 vaccine  was not applicable. The patient recovered from period delayed by two weeks on MAY-2021, had not recovered from lethargic (fatigued/ very tired/ unable to get out of bed), and the outcome of winded from walking and running was not reported. This report was non-serious. This case, from the same reporter is linked to 20210537297.
(left) arm 3x3" area progressing to 3 x 12"; Pain injection site (Left) arm; A spontaneous report was received from a consumer concerning a 56 years old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain injection site (left) arm /vaccination site pain, rash (left) arm 3x3 area progressing to 3 x 12 /rash.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Feb 2021,approximately 1 day prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 006M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient experienced the event(s) pain injection site (left) arm. On 18 Feb 2021, the patient experienced the event(s) rash (left) arm 3x3 area progressing to 3 x 12.  Treatment details included antibiotics.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), pain injection site (left) arm was resolved on 13 Feb 2021 . The outcome of event(s), rash (left) arm 3x3 area progressing to 3 x 12 was unknown.
Increase of Atrial Fibrillation (Afib) events and severity. For the 20 years preceding the Covid shot, I had 1-2 Afib events in low severity about every 8 months and only one severe event in 2008. Since getting the Covid shot, I've had 1 event every week with 2 severe events and 2 emergency room visits. Three cardiologists have confirmed my condition and verified my event history and the increase in frequency. My workouts have been relatively the same for 3 years. Now, after any workout that I push to failure, onset of Afib occurs approximately 4-6 hours later with a medium to high severity. Afib Severity: Low; occasional light headed when exerting. Medium; weakness, need to sit. Severe; semi/or unconscious.
Pt described getting stomach flu-like symptoms the next day - vomiting and diarrhea - and that since then she has had an earache and sore throat.
Information has been received from a medical assistant concerning a 6 year old male patient who on 18-AUG-2009 was vaccinated with the second dose of 0.5ml VARIVAX (Merck) (lot # 664502/0687Y). The expiration date on the vaccine was 15-MAY-2011. There was no concomitant medication. The medical assistant reported that "He was a little bit nervous before the shot, but not abnormally anxious. 5 minutes after vaccination the boy complained of chest pains, a sore throat and said it was hard to swallow. The patient's pulse was 98. The doctor listened to his lungs and the doctor felt that there was a small amount of stress in the lungs. The doctor told him to sit for 5-10 minutes. While sitting, he began vomiting. At the time he did not have shortness of breath, hives or a rash. The office called EMS. When EMS came, the patient was well enough for the mother to drive him to a hospital. When the arrived at the hospital, the hospital nurse said he had minor lip swelling and a rash from head to toe. He received prednisone and a dose of BENADRYL. An electrocardiogram (EKG) was done and he was observed in the emergency room. He was not admitted and he did go home at the night of 18-Aug-2009. On 19-Aug-2009 he was examined at the doctor's office by a different doctor. The patient had a complete exam. The rash was completely gone. There was ho wheezing, the airway was clear and the patient was instructed to finish the prednisone." The patient's adverse events improved after stopping therapy. It's unknown if the patient recovered on 18-AUG-2009 or 19-AUG-2009. It's also reported by a physician that there was no AE after the first shot. Additional information has been requested.
pt recv vax 31OCT97 & 5min p/vax pt exp a sz;the pt regained consciousness, was kept in the MD office for 1hr then adm to hosp for observation & EEG eval;
Patient received the COVID vaccine (Janssen, lot #205A21A use by 08/07/2021) at 1101. Pharmacist vaccinated the client at 1101 and as she was talking to him after administering the vaccine, the client began to slouch to the side in the chair. The client's eyes were closed when RN ran to station and EMT both assisted the client to the ground. The client loss consciousness for approximately 20 seconds and had no head trauma. The client's legs were elevated immediately by being place on a chair after he was placed supine on the floor. and his face mask was removed. The client regained consciousness at 1102 and was A & O x 4. The client was pale and denied shortness of breath, difficulty breathing, chest pain, dizziness, or difficulty swallowing. EMT took vitals at 110 BP: 115/75, HR: 46, RR:20, oxygen saturation: 98%, the client's color returned, skin was pink and warm. Client stated," I feel like I just took a nap, I feel good." The client reported nearly fainting in the past with getting his tattoo and fainting with the removal of stitches.  The client was given Gatorade and was offered Pringles, the client denied the Pringles but did have a few sips of Gatorade. The client did not eat breakfast prior to being vaccinated. Denied having any known drug allergies, currently taking any medications, or having any chronic medical conditions. The client was placed in a supine position and then slowly placed in a sitting upright position. Denied any lightheadedness, dizziness, changes in vision, chest pain, or shortness of breath. EMT took vital signs at 1108, HR- 122/82, HR-54, RR-18, oxygen saturation- 99%. The patient then ambulated to the anti-gravity chair with assistance, by EMT and PM. The client placed his face mask back on and was offered a granola bar. The client stated," I'm tracking my macros and I need to check my app." The client then at the granola bar. EMT took vitals at 1113, BP- 122/80, HR-57, RR-18, oxygen saturation-97%. The client denied any oral trauma, head trauma, or incontinence. A final set of vitals were taken at 1121 EMT BP-120/80, HR-54, RR-16, oxygen saturation: 98%, the client stated, " My heart rate is usually in the 40's, I play Rugby." RN advised the client to follow-up with his primary care provider and educated the client about agency and emergency room precautions.  The client was advised by RN to have his friend drive him home, him and his friend verbalized understanding. The client's friend was observed in the observation area after receiving COVID vaccine. The client left the site at 1202 with his friend, and had a steady and even gait.
Father is a physician, mother called school nurse and reported child had a light case of chickenpox.
Patient received vaccination on 10/16 and called the following day on 10/17 to report a red circle located approximately 6 inches below where she received vaccination. She said the circle is slightly painful to touch.
Information has been received from a pharmacist via a employee referring to a male patient of unknown age. Two years ago (in approximately 2013) the patient was vaccinated with a dose of ZOSTAVAX (strength, dose and route not reported). On approximately 19-FEB-2015 (reported as two weeks ago) the patient was diagnosed with shingles by his unspecified provider. The patient sought medical attention by visiting with unspecified provider. The patient was prescribed NORCO for treatment. At the time of reporting, the patient did not recover from this event. Causality between the event and ZOSTAVAX was unknown. Additional information has been requested.
Tachycardia Episode occurred 24hrs following Covid vaccine 9/27/2023.
tinnitus both ears, hearing loss, petechiae all over skin,  lowered platelet counts after vaccination
Injection Site Redness, swelling, pain, and itchiness. Fatigue.
Patient presented for varicella vaccine, I administered MMR. After realizing the error, I administered VARIVAX, patient immediately notified of error.
achy injection site left arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (achy injection site left arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PAIN (achy injection site left arm). At the time of the report, VACCINATION SITE PAIN (achy injection site left arm) outcome was unknown.            No concomitant medications was reported.  On 23-Mar-2021, the patient complains of a sore left arm, achy injection site left arm after the First vaccination and again on 20-Apr-2021 patient complains of a sore left arm, achy injection site left arm after the second vaccination.  No treatment medications was reported.   This case was linked to MOD-2022-670196 (Patient Link).
Miscarriage occurred at home; Ultrasound revealed no heartbeat; Took Flu vaccine and Pfizer covid vaccine on same date of 13Oct2022; Took Flu vaccine and Pfizer covid vaccine on same date of 13Oct2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 3 (booster), single (Lot number: GH9702) at the age of 35 years for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 13Oct2022 as dose number unknown, single (Batch/Lot number: unknown), in arm. The patient's relevant medical history included: "If COVID prior vaccination: Yes" (unspecified if ongoing), notes: If COVID prior vaccination: Yes; "Test: Nasal Swab Result: Positive", start date: 05Feb2022 (unspecified if ongoing). Concomitant medication(s) included: FISH OIL; VITAMIN D3. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EW0181), administration date: 01Jul2022, when the patient was 34-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EW0178), administration date: 10Jun2022, when the patient was 34-year-old, for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 13Oct2022, outcome "unknown" and all described as "Took Flu vaccine and Pfizer covid vaccine on same date of 13Oct2022"; FOETAL HEART RATE ABNORMAL (congenital anomaly) with onset 22Dec2022, outcome "recovering", described as "Ultrasound revealed no heartbeat"; ABORTION SPONTANEOUS (congenital anomaly, medically significant) with onset 26Dec2022, outcome "recovering", described as "Miscarriage occurred at home". The patient underwent the following laboratory tests and procedures: Pregnancy test: (14Nov2022) Positive, notes: Positive pregnancy test recorded at physician 14Nov2022; SARS-CoV-2 test: (05Feb2022) Positive; Ultrasound scan: (22Dec2022) No heartbeat, notes: Ultrasound revealed no heartbeat on 22Dec2022. Therapeutic measures were not taken as a result of abortion spontaneous, foetal heart rate abnormal.  Additional information: Became pregnant approximately 21Oct2022. Positive pregnancy test recorded at physician 14Nov2022. Ultrasound revealed no heartbeat on 22Dec2022. Miscarriage occurred at home on 26Dec2022. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.
In between my shoulder blades and back feels like something is there. I've got worse exp headaches have history of migraines in the past. In August 2020 was exposed to Covid 19 headache was worse than now. In the past have seen neurologist for migraines and not exp migraine felt like this in 5 yrs. On 12/17 body pain, headache, and high grade, diarrhea(loose stool) and  fever 101.7.After checking temp on 12/18 was 98.8.Pt had to miss one day of work on 12/17.
Initially I got a red bump around the injection site shortly after receiving the shot. It went away after 2 days, but 4 days after i got the shot I broke out in hives. They have spread and now cover my whole body. Legs, arms, hands, back, feet are covered in bumps. I have to take Benadryl every 4 hours or else they itch like crazy. Cortisone creams help with the inflammation but it's been 3 days with the hives and they're just getting worse instead of better. I had a virtual appointment and my doctor told me to just keep taking benadryl but I am going through a ridiculous amount of allergy creams/pills/ointments and there is no end in sight. Relief for a mere 4 hours before the itching starts again. If I wasn't mandated by my employer to get the second dose of this stupid vaccine I wouldn't as I'm concerned I will have a worse reaction! I expected initial discomfort but not endless hives!!!
The caller said that she got COVID in early 2020/when the vaccines started to wear off, she got the symptoms back; The caller said that she got COVID in early 2020/when the vaccines started to wear off, she got the symptoms back; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: 2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "The caller said that she got COVID in early 2020/when the vaccines started to wear off, she got the symptoms back". Clinical course: The reporter said that she got COVID in early 2020, and then in Jan, the vaccines were available, and she started picking Pfizer. The reporter said that she had long-haul symptoms, and Pfizer helped her remove almost all of her long-haul symptoms. The caller stated that when the vaccines started to wear off, she got the symptoms back, and Pfizer took them away again. The caller said that she got one booster in the spring. The caller said that it was keeping her healthy. So this year she had not gotten the vaccine, and she was having a hard time finding Pfizer bivalent.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events drug ineffective and Covid-19 are  related to bnt162b2 (BNT162B2)  cannot be excluded.  This case will be reassessed should additional information become available.
I experienced Covid-19 on November 17, 2022, my symptoms were tiredness, body aches, sinus pressure, fever, head pressure. I was prescribed PAXLOVID and also vitamins on that evening.
Information has been received from a health professional concerning a 26 month old female with no medical history or allergies who on 02/12/04, at 10:30AM, was vaccinated in the right thigh with a first dose of varicella virus vaccine live (Lot # 647246/0899N).  Concomitant vaccination the same day included a fourth dose of DTAP 3-component vaccine (+) tetanus toxoid (Infanrix)(Lot # 622A2) given in the right thigh and a fourth dose of Hib conj vaccine (Prohibit, Lot # UE096AA) given in the left thigh. At the time of vaccination, the pt had resolving bilateral otitis media and was on Amoxil. Two days post vaccination on 02/14/04, the child was taken to the ER covered head to toe with a blotchy rash. The pt was treated with an unspecified medicine and was released. On 02/18/04, it was reported that the pt was recovering with sequelae. There was no product quality complaint involved. Follow up information indicated that the pt developed a rash on 02/14/04.  The rash was described as a diffuse macular papular rash from head to toe, warm to touch with slight warmth bilaterally to knees and elbows. It was noted that the rash was erythema multiforme.  The pt was very irritable. She was treated with Benadryl which did not help and Zyrtec twice daily.  Additional information has been requested.
I had mild tinnitus before getting the Pfizer shot. Within one day of the shot, I had much louder ear ringing. It goes down at times, but often comes back loud. The louder tinnitus largely has persisted for nearly a year after the shot. That's why I never got a second shot or booster. New or louder tinnitus was not listed as a side effect. Many people have gotten it after the shot. It should have been listed. If it had, I probably would not have gotten the vaccine.  As a healthy person, the risk of severe Covid was low. I'd rather take that risk than have a permanent disability from the vaccine (loud ear ringing).
11:45 am 1/12/21 received Covid vaccine.  Shellfish allergy and required to stay 30 mins for observation post vaccine.  No symptoms during 30 minute observation post vaccine administration.  Approximately 12:45pm right hand, tongue, mouth started tingling, and felt tongue was swelling.  Reported feeling flush with chills, headache, and generalized weakness in legs.  Went back to vaccine clinic to report symptoms at 2:15pm.
PT was totally fine until about 48 hours after the shot, when on her way to soccer she became dizzy, said she felt like she was in a dream and noises were echoing, arms and legs felt tingly. She was quiet but when she talked it was very slow with her words slow and almost slurred. At home she was very pale, tired. No fever. She ate dinner, but her speech continued to be slow - like her mouth wouldn't work . She was not disorientated, she knew what was going on but said it was hard to move her mouth and face. She fell asleep for a few hours, and developed a hive on her upper left cheek. Upon waking around 8 pm she seemed more with it, speech a bit better. Went to sleep and in the morning was still tired, but better. By mid day 11/16/2021 she was fine.
injection site was rock hard; injection site was red; injection site was hot; extremely sore; A spontaneous report was received from a consumer concerning a 36-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the injection site being "rock hard", red, hot, and extremely sore /vaccination site induration, erythema, warmth, and pain.   The patient's medical history was not provided. Concomitant medications reported included valacyclovir hydrochloride, diclofenac, and nitrofurantoin.   On 15 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) intramuscularly for prophylaxis of COVID-19 infection.    On 15 Jan 2021, the patient received the Moderna Covid-19 vaccine. On 23 Jan 2021 she noticed that the injection site was rock hard, red, hot, and extremely sore. Treatment for the events was not provided.     Action taken with mRNA-1273 in response to the events was not reported.    The outcome events were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pt evaluated at minor care for red spotty rash noted on abdomen. Pt does not exhibit fever, cough or runny nose. Advised possible reaction or virus due to vaccine. advised on Hydrocortisone cream as needed and avoid immunocompromised pt and or pt's unvaccinated.
brushy, itchy arm; hot to touch; Red arm 10 days after receiving the Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (brushy, itchy arm), INJECTION SITE WARMTH (hot to touch) and INJECTION SITE ERYTHEMA (Red arm 10 days after receiving the Moderna COVID-19 vaccine) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 28-Jan-2021, the patient experienced INJECTION SITE PRURITUS (brushy, itchy arm), INJECTION SITE WARMTH (hot to touch) and INJECTION SITE ERYTHEMA (Red arm 10 days after receiving the Moderna COVID-19 vaccine).   At the time of the report, INJECTION SITE PRURITUS (brushy, itchy arm), INJECTION SITE WARMTH (hot to touch) and INJECTION SITE ERYTHEMA (Red arm 10 days after receiving the Moderna COVID-19 vaccine) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
fever, myalgias, nausea with vomiting, loss of appetite, fatigue, shortness of breath, severe cervical and axillary lymphadenopathy, severe headache, light headedness
Left arm pain from shoulder to hand. Hand pain has since gone away, arm pain remains. Movement of arm is minimal.