chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Fatigue; This is a spontaneous report received from contactable reporters (Consumer or other non HCP) from a sales representative.  A 17-year-old male patient received BNT162B2 (BNT162B2), administration date 20Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 21Mar2021, outcome "recovered" (22Mar2021), described as "headache"; FATIGUE (non-serious) with onset 21Mar2021, outcome "recovered" (22Mar2021), described as "Fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient arched backward, tensed up, eyes rolled back in head, stopped breathing, face turned red which lasted about 1 minute then she became limp and unarousable. Patient was unable to keep her head up she kept trying to open her eyes and head would nod up and fall. This lasted about 10 minutes. She was very sleepy and after 15 minutes started to act normal again.
Swelling & redness. Cellulitis. Ibuprofen 600mg up to three times daily, heat/compress, ROCEPHIN 1gm IM x 2 & Cephalexin 500mg three times a day x 10 dys.
Administered on 2/19/2023, The BUD for this vial was 2/18/2023
This spontaneous report as received from a nurse refers to a 4 week old patient of an unknown gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the 4 week old patient was vaccinated with ROTATEQ orally (strength, frequency, lot number and expiration date were unknown). There were no concomitant therapies provided. No adverse events were reported. Additional information is not expected because no permission to contact the physician was provided.
rash; This is a spontaneous report from non-contactable consumer (patient).   A female patient of an unspecified age BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and expiration date: Not reported), via an unspecified route of administration, administered in Arm, on an unknown date in Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On Mar2021, after first vaccination (on Saturday) patient experienced a rash on her forearm and wanted to know what to do and how to treat the rash. The clinical outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
High racing heart rate began at 6 pm after shot was peaked at highest at 530 am with 155 bpm at rest went to er d diner elevated ct of chest taken was clear sent home. Continued to have little spikes of high hr for about 7 days. Also site was swollen and rock hard about size of orange  red and itchy . Red and itchy for seven days and warm to touch. Hard knot that took 1 month to completely go away
After administer varicella on left thigh and MMR on right thigh, Each leg became red at injection site. On right leg where MMR was given, welts around injection site, Benadryl was given + the redness and welts disappeared.
Within an hour, I had broken out in hive-like, chicken pox one by one. It started on my right on where I received vaccine and has now spread down both arms, my legs, feet, hands, back of neck, and chin. They are extremely uncomfortable and itchy. It?s been 12 hours since my shot, and rash has only gotten worse. Benadryl and Hydrocortisone Cream isn?t helping much.
Diffuse urticarial reaction; at time of f/u visit for urticaria child did have cough and runny nose.
rashes were itchy; developed rashes all over the body; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rashes were itchy) and RASH (developed rashes all over the body) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced RASH PRURITIC (rashes were itchy) and RASH (developed rashes all over the body). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (rashes were itchy) and RASH (developed rashes all over the body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
This spontaneous report was received from a healthcare professional concerning a patient of unknown age and gender, who was vaccinated on 05-JAN-2014 with VARIVAX (Merck) (dose number, strength, lot number and expiration dates was not reported), 0.5 ml, subcutaneous, that was improperly stored. No adverse effect reported. Medical history and concurrent conditions were not reported. Additional information has been requested.
On 8/2/10 at 1600 had vaccines and at 1800 developed itchy rash and hoarse voice. Relief with medication CLARITIN taken 2300. On 8/3/10 itchy rash returned seen in dept. No tx.
Madison went to bed at 7:00pm, at approximately 10:15pm, her mother heard her whimpering, she picked her up put her head on her shoulder, then Madison went limp and her eyes were rolling back in her head and she was unresponsive and started convulsing, and running a temp of 102.9 We called 911 and she was taken by ambulance to the Er and treatment was given, the Er Dr checked her out and found no other reason for the High Temp and seizures,
Pt received Flu, Pneumonia and Hep A vaccines yesterday. Developed generalized pruritus rash about 1 hour after vaccine. Nausea, flu like symptoms. No throat swelling, no SOB, no stomach pain.
Varivax administered on 02/14/2005, patient returned to office on 02/21/2005, per physician with "varicella like" rash 1 week after varivax.  Recommended to report to VAERS.
I have a symptom of rheumatoid arthritis in my hands.  Every morning for approximately the past month, I have woken up with stiff/painful joints.  The pain gets better throughout the day, but never goes away.
dose #1 on 2/14/2019 and then missed 2nd dose; This case was reported by a other health professional via interactive digital media (Shingrix GSK Chatbot) and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 14th February 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided are as follows: The age at vaccination was not applicable. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked if the patient could receive 2nd dose now. No further information was reported.
Upon injection,  burning at injection site (expected). Burn area the size of open hand spread out, traveled down outside left upper arm into armpit and into elbow and inside forearm to wrist by day 3. Day 3, 4, and 5, pain held at inside forearm and started radiating into base of left thumb. Day 5 - pain in injection site is waning, inside forearm still sore to touch. Tingling in left hand upon waking in the morning. Arm is irritated all day. Pain slightly alleviated with 500 acetaminophen taken on day 3 and 4.  Contacted my Dr through Portal email, no return response yet.
Pt complains that 31/2 wks after receiving 3rd GARDASIL injection - came down with shingles. (Pt just wanted to notify us with information
History of Present Illness  The patient presents with weakness.  The course/duration of symptoms is constant.  The character of symptoms is generalized.  The degree at present is moderate.  Associated symptoms: abdominal pain.  73 y/o M who comes in from home for generalized weakness. PT states that he was feeling well until after he went to bed tonight. around 1 am he attempted to get up and go to the bathroom and his wife had to help him. She was able to get him up and he went to the bathroom but he seemed more shakey than usual. He then tried to get back up around 230 am and he was very shakey, said he was cold, and he could tno stand. She attempted to stand him up and she was not able to get him up and move him at all because he was so generally weak. No fevers that he knows of. He did recieve his first dose of the covid vaccine this afternoon. He was well after that and went to dinner and was well until he went to sleep. He has a h/o HTN, HLD, and tremor. Pt did have covid in early december as well. .    Notes: 73 y/o M who comes in from home for generalized weakness. Pt is alert and awake but slower to respond than his usual per his wife. Labs are overall reassuring. His etemp is elevated but afebrile. CXR with possible atelectasis vs infiltrate but pt has no cough, no fever, and a normal WBC Coutn so I favor atelectasis. His CT head shows possibly artifact vs cortical hypodensities. Will await formal read this morning. Pts UA is clean. He is no longer shaking after a dose of tylenol and ativan. I suspect the pts generalzied weakess is 2/2 his recent covid vaccine yesterday afternoon. Despite this the pt cannot stand and move around on his own and his wife cannot care fo rhim at home given his current situation. Pt discussed with Dr and will be admitted for further care. .    Impression and Plan  Diagnosis  COVID-19 vaccine series started  Rigors  Tremor  Weakness  Weakness or fatigue  Plan  Condition: Improved, Stable.   Disposition: Admit time  3/12/2021 06:27:00
Information has been received from a 52 year old female physician with a drug hypersensitivity to teraconazole and history of a spinal cord injury at L2 in 1981 who on 23-AUG-2007 was vaccinated with a dose of PNEUMOVAX.  Concomitant therapy included DITROPAN and MACRODANTIN.  On 24-AUG-2007 the patient developed redness, erythema, and soreness at the injection site.  The erythema was the size of a nickel during the day and increased to the size of a quarter by the evening.  The erythema progressed over 4 days to the size of 13 cm x 6 cm.  She had a temperature of 101 F and the erythema was 2 cm by 4 cm.  She had pain that she rated as 10 out of 10 and reported that her arm was non functional from the pain.  She went to the emergency room and was treated for cellulitis.  She was put on KEFLEX.  She called the Center for Disease Control for consult and was informed that it was probably and immune reaction.  She discontinued KEFLEX and took MOTRIN around the clock.  Subsequently, she developed 4 new satellites in which the lesions were blotchy and was about the size of a dime.  There were no laboratory or diagnostic tests performed.  At the time of the report the patient had not recovered.  Additional information has been requested.
gave 0.25 mL to an older adults; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (gave 0.25 mL to an older adults) 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. AS7146B) 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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (gave 0.25 mL to an older adults) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (gave 0.25 mL to an older adults) 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 assessment was provided for ACCIDENTAL UNDERDOSE (gave 0.25 mL to an older adults).    No concomitant medications were reported. It was reported that vial fill volume was possibly too high. The vial was punctured five times. The Five doses extracted from the vial. Five patients dosed from the vial. No treatment medications were reported. This Case for Adult patient 4.   This case was linked to US-MODERNATX, INC.-MOD-2022-673533, US-MODERNATX, INC.-MOD-2022-673577 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2022: Live Follow-up received contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-673533: US-MODERNATX, INC.-MOD-2022-673577:
Itchy palms,blotchy,/w a chemical taste in mouth,numbness of the tip of tongue.As of 24May still c/o abdo pain.Presented today /w apost auricular area node on same side as inject. 26Jun90 F/U asymptomatic as of 23May90.Abdo pain due to milk
This spontaneous report was received from a nurse via a company representative refers to a 52 year old male patient. The patient's concurrent condition included asthma, Crohn's disease, anemia, osteopenia, malabsorption syndrome, vitamin d insufficiency, COPD (Chronic obstructive pulmonary disease), GERD (Gastrooesophageal reflux disease), nocturia, emphysema and smoking. On 12-JUN-2014 the patient was vaccinated with PNEUMOVAX 23, lot # J013345, Exp Date 11-JAN-2015, 1 single shot, intramuscular. Concomitant therapies included budesonide, SYMBICORT, SINGULAIR, ACTONEL and PROAIR. On 13-JUN-2014 the patient's left arm became swollen from the shoulder to the elbow after receiving PNEUMOVAX 23. The patient seek medical attention and received BENADRYL as a treatment for the adverse event. There were no laboratory diagnostics performed. The outcome of the event was reported as not recovered/not resolved. This is one of several reports received from the same reporter.
Diarrhea; chills; low grade fever; body aches; fatigue; Dose number = 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Dec2021 11:45 (Lot number: FD7218) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Eczema" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "Known allergies: Sugar" (unspecified if ongoing); "Known allergies: wheat, corn" (unspecified if ongoing); "Known allergies: dairy" (unspecified if ongoing); "Known allergies: soy" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM; SUMATRIPTAN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0158, Location of injection: Arm Left), administration date: 12Apr2021, when the patient was 41 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534, Location of injection: Arm Left), administration date: 22Mar2021, when the patient was 41 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Dec2021 11:45, outcome "unknown", described as "Dose number = 3"; DIARRHOEA (non-serious) with onset 27Dec2021 17:45, outcome "recovering", described as "Diarrhea"; CHILLS (non-serious) with onset 27Dec2021 17:45, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 27Dec2021 17:45, outcome "recovering", described as "low grade fever"; PAIN (non-serious) with onset 27Dec2021 17:45, outcome "recovering", described as "body aches"; FATIGUE (non-serious) with onset 27Dec2021 17:45, outcome "recovering", described as "fatigue". Therapeutic measures were not taken as a result of diarrhoea, chills, pyrexia, pain, fatigue.  Additional Information : Prior to vaccination and since the vaccination the patient had not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received multivitamin within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store.  No follow-up attempts are possible. No further information is expected.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Constant prolonged pain, soreness, burning, throbbing sensation, hoarseness, persistent coughing, shooting pains in arm, hand, shoulder, neck and head, etc. Also, had persistent nausea and vomiting AM and PM, problems with use of arm plus pain in fingers all through the day and night. Problems with lightheadedness, coordination and balance problems, aches, body fever 1 day, attacks of pain attacking all body parts except my buttocks. Problems with weakness, fever again, slight rash on both sides of neck, redness on front of neck, pain in lower back and kidney area, knee's throbbing and on 2 different days, I suffered some weird stinging, sort of heated pain from left arm into my whole left side neck and my left breast. I had pain right above my eyes. Constant pain medication still not helping. Constant blurry vision and burning sensation in both eyes. (Going to make eye clinic appt to have eyes checked). My joints hurt sometimes so bad that I can't walk or move.
didnt feel well after getting flu vaccine; Initial information received on 20-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves Adult female patient (61.8 kg) who didn't feel well after getting flu vaccine while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VACCINIUM SPP. (CRANBERRY [VACCINIUM SPP.]); ASCORBIC ACID (VITAMIN C [ASCORBIC ACID]); COLECALCIFEROL (VITAMIN D3); SALBUTAMOL SULFATE (ALBUTEROL SULFATE HFA); and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT).  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength, dose and lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient didn't feel well after getting flu vaccine (malaise) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (didnt feel well after getting flu vaccine).  At time of reporting, the outcome was Unknown for the event.; Sender's Comments:  SanofiPVPortal20221024000027:
Patient was known to have fainting spells due to seeing blood in the past while in his doctor office. Shortly after immunization took place he fainted. We laid him down on the ground and propped his feet up. After a few moments he came to. He confirmed he was able to leave after another 15 minutes of monitoring.
2° fever first day after shot Significant fever blisters on lips 4 days after shot
Given HEP A #1 and MENACTRA at 10AM, Friday, 9/26.  That evening noted pain/swelling left axilla which continued to worsen next 2 days.  Visible swelling Sunday PM and felt bad overall.  Starting to improve Monday when seen again in office with lymphadenopathy.
ASSESSMENT: apparent vaccine related injury with significant ADL reduction. Appears to have brain inflammation /glial cell activation, candidiasis, viral co-infections, mitochondrial deficiencies . Does have history of PTSD and BiPolar but this does not seem to be driving his issues. and sleep apnea is managed with a bi-pap device. Extreme fatigue, Petechial rash, Lesions in mouth and throat for weeks. Severe Depression, Suicidal, Breakthrouth ADD 5000X, debilitating loss of memory, processing speed, executive function skills. Mild cognitive impairment,Severe verbal narrative learning issues, organization impairment, activation issues, nausea, exhaustion, loss of appetite, off of emotions, Have to read things over and over and over rand over and am lucky to remember something.  Its starting to improve. Feel like I now have the mind of a 1st grader.  Muscle stiffness, spasms. Cardio exercises make me feel bad now, shaky hands (harder to tap a screen accurately or hold things or type or write), ever cold fingers and toes even in summer. reactivated Ebstien Bar virus (still active), Cytomeglovirus (recently active as of early 2022), and HHV-6 (recently active) .  All the has been a dramatic life altering experience. I have been able to find some good in learning to appreciate the simple really simple things in life. I was a technology executive but have been on disability since may of 2021 working hard to jumpstart my brain to take a run back into a career as i learn more about the aides i'll want to bring along the way. I have lost myself in this experience. My wife asks me a lot "where are you"? I tell her I'm right here. It hurts when you don't even know how to fix it, or that she "wants her husband back". She told me the other day that my son had lots of worries about his dad that his only memories are of me being sick with no energy mostly in a chair wondering when I was going back to work.  I've lost out on time with self. Time with Family. Time with friends, memories, Stock grants, percentages of salary, bonus income, MY HEALTH although i'm slowly clawing it back
Patient passed out after receiving first dose of Pfizer COVID19 vaccine. He did not hit the ground as someone else caught him. His BP was taken and read 70/59 originally and then came back up to 144/83 after laying on floor with feet on chair. Patient said that this has happened before when giving blood or dealing with needles.