chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shoulder and arm began to experience some pain; shoulder and arm began to experience some pain; Tightness; Red and White Spot; Red and White Spot; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (shoulder and arm began to experience some pain), PAIN IN EXTREMITY (shoulder and arm began to experience some pain), MUSCLE TIGHTNESS (Tightness), VACCINATION SITE ERYTHEMA (Red and White Spot) and VACCINATION SITE DISCOLOURATION (Red and White Spot) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L208) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (shoulder and arm began to experience some pain), PAIN IN EXTREMITY (shoulder and arm began to experience some pain), MUSCLE TIGHTNESS (Tightness), VACCINATION SITE ERYTHEMA (Red and White Spot) and VACCINATION SITE DISCOLOURATION (Red and White Spot). At the time of the report, ARTHRALGIA (shoulder and arm began to experience some pain), PAIN IN EXTREMITY (shoulder and arm began to experience some pain) and MUSCLE TIGHTNESS (Tightness) outcome was unknown and VACCINATION SITE ERYTHEMA (Red and White Spot) and VACCINATION SITE DISCOLOURATION (Red and White Spot) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment : Cold compress
Shivering and chills despite being 11c outdoors and being inside and in pajamas and under a duvet. Strong muscle spasm cramping in calves, made it difficult to walk to get even get water. Very sore arm, could not lift, and strong fatigue GI issues (slight diarrhea clumps but not many)
sudden onset of rinorrhea 5 minutes after receiving vaccine.  then itching near ears, 5 minutes later had diffuse itching a rash, was sent to ED.  There was evaluated for mild shortness of breath and hives on wrists.  Did NOT et epi but did get benedryl and steroids, discharge home
This was my second shot in the series of two.  Adverse symptoms were :  Sore arm, body aches, nausea, dry heaves, diarrhea, bad headache.  Feeling better now and assume I will continue to do so.  Sick for about 18 hours.  Had only a sore arm after the first injection on February 7 from same Pharmacy.
After first shot, I had severe fatigue, exercise intolerance, migraines, dizziness.  Afrer second shot, I had the same fatigue, exercise intolerance, migraine, dizziness, tachycardia, electrolyte imbalances, pins and needles all over my skin, light and sound sensitivity, GERD.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 13Jan2021 at 14:00 as dose 1, single (Lot number: EJ1686), on 04Feb2021 at 14:00 as dose 2, single (Lot number: EN5318), on 12Dec2021 at 12:00 as dose 3 (booster), single (Lot number: FE3594) and on 25May2022 at 10:00 as dose 4 (booster), single (Lot number: FN2908) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Vitiligo" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "known allergies: Morphine", notes: known allergies: Morphine. The following information was reported: VACCINATION FAILURE (medically significant) with onset Jun2022, 6 days 22 hrs after the suspect product(s) administration, outcome "unknown", COVID-19 (medically significant) with onset Jun2022, 6 days 22 hrs after the suspect product(s) administration, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jun2022) positive; (14Jun2022) negative; (15Jun2022) negative; (16Jun2022) negative; (21Jun2022) positive; (22Jun2022) positive; (23Jun2022) positive; (24Jun2022) positive; (26Jun2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. No follow-up attempts are possible. No further information is expected.
Soreness in the arm , sore throat Mild fever, Pain at the injection site. Headache that
No adverse event; Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in an elderly 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 25-May-2023, 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 25-May-2023, the patient experienced UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml) 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 UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported. It was reported that patient had their monovalent and a previous booster dose of bivalent vaccine. Treatment medications were not provided.  This case was reported for elderly patient 3 of 20.   This case was linked to US-MODERNATX, INC.-MOD-2023-726464 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726464:Elderly Patient - 1
Pfizer-BioNTech Covid Vaccine EUA On 1/29/2021, Fasiculations started in both legs (below the knees) at 7pm, 5 hours after the shot. The gnarly, very painful cramps of my feet and ankles started in the right foot at 7:30pm.....last about 10-12 minutes, then the left foot/ankle, again for 10-12 minutes. I have and took Gabapentin 600 and had relief from the cramps by 9:30pm. The fasiculations continued for 24 hours. At this point (25 hours later) my feet and ankles have a dull ache but I do not expect anymore cramps. This is an autoimmune disease for me but I have not had an episode this bad in a year.     PS - It?s worth it to take the vaccine!
Patient experienced light headed feeling, and brief loss of conscious. Patient was cold and clammy to the touch. Issue resolved within about 20 minutes of rest.
Right arm with edema from deltoid to approximately one inch above elbow - pain on palpation - mild bruising at injection site.  Currently on amoxicillin 250mg/5ml 1 teaspoon for urinary tract infection.  Motrin 100mg/5ml 2 teaspoons as needed- ice/heat combination, elevation to right upper extremity.
Post vax, 5" x 5" red rash was noted by the patient's mother. The rash feels warm to the touch. There are no other symptoms mentioned.
Patient did not experience adverse reaction. Pt was given TDAP in error. He should've received DTAP.
Chills. lathargic, Temperature/fever of 101 deg.  i am normally around 97.3 deg.
5 hours after injection I was shivering with fever and  body aches and head ache.  Next day  same symptoms, no taste and slept a lot. Second day after I  still  Ache, brain is not as foggy as first onset, and not as high a fever.  I had covid in September and this was exactly the same minus the vomiting and diarrhea I had with the virus.
became lethargic, limp, difficult to arouse although did awaken for some feeds; no fever or pallor; recovery w/in 24 hrs;
Rash on left arm bicep region where shot was given. Weeks later I had a fever, with fatiguing and wooziness. Week after that there was hives on my buttocks, swelling of the hands, feet, and face (Mouth, lips, and jaw line). All symptoms have gone away except for the hives and swelling of the hands, feet, and mouth.
p/ pt recv vax approx 3yrs later the pt was dx w/chickenpox w/maculopapular vesicles
08/07/08 Client recieved vaccines, client turned pale, c/o nausea, tingling felling in fingers t 98.2, P62, B/p 98/66 called EMT monitored client 30 min. 08/12/08 called follow-up mother states pt. c/o headaches, body aches, not eating well, no fever, refer to ER.
9 days after vaccine experienced redness, swelling, itching, warm to touch at injection site on left arm. Just used topical antihistamine (Benadryl cream) and oral antihistamine (Benadryl 50 mg). Also took anti-inflammatory Ibuprofen 600 mg. Symptoms greatly improved the next day and found no need to been seen by a physician.
spotting vaginally; miscarriage; Following the vaccine on 18Mar; This is a spontaneous report from a contactable consumer (patient). A pregnant 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 18Mar2021 at 17:00 (at the age of 31 years old) (Lot Number: EN6204, unknown expiration) as a single dose for COVID-19 immunisation.  Medical history included anxiety. No known allergies. Concomitant medications included escitalopram oxalate (LEXAPRO) and unspecified prenatal vitamins.  The patient reported that following the vaccine on 18Mar2021 at 23:00 (11:00 pm), she began spotting vaginally which persisted for two weeks and resulted in a miscarriage at 7 weeks pregnant. The patient is pregnant on 04Jan2021. The mother was supposed to deliver on 19Nov2021.  The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not received treatment for the events. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not have other vaccine in four weeks.  The patient is recovering from the events.   No follow-up attempts are possible. No further information is expected.
Pfizer 1st and 2nd doses were taken a little over six months ago in April and May.  Moderna booster resulted in fairly severe pain (soreness, as though exercised heavily) at bicep and upper left arm, joint discomfort (the most disconcerting symptom) in arms and especially wrists/ankles, and general tiredness/muscle weakness/lightheadedness.  Symptoms set in all at once three hours after injection (I believe muscular).  Ongoing symptoms without any reduction for five hours so far; an ibuprofen has done relatively little.
fever 103 x 24hr;body aches & joint pain 48hr;mom suspicious that testicules, torsion which occurred 3 days later;
pt recv vax AUG95 & was exposed to a child w/chickenpox;subsequently pt devel chickenpox blisters;it was reported pt devel chickenpox blisters whenever exposed to a child w/chickenpox;
hives; rash; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 50 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 11Jan2021 (Batch/Lot number: unknown) at the age of 49 years as dose 2, single and administered in arm, administration date 21Dec2020 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "He has a history of allergies" (unspecified if ongoing), notes: He has a history of allergies; "blood pressure" (unspecified if ongoing), notes: he just recently started on blood pressure medication , he is taking metoprolol because his blood pressure was creeping up.; "Cholesterol" (unspecified if ongoing), notes: His Cholesterol was at 200 and he is taking metoprolol because his blood pressure was creeping up. Concomitant medication(s) included: METOPROLOL taken for blood pressure abnormal; LIPITOR taken for blood cholesterol abnormal. The following information was reported: URTICARIA (medically significant), outcome "not recovered", described as "hives"; RASH (non-serious), outcome "not recovered", described as "rash". The patient underwent the following laboratory tests and procedures: blood cholesterol: 200, notes: His Cholesterol was at 200. Therapeutic measures were taken as a result of urticaria, rash.  Clinical course- The patient on steroids, creams, and every type of allergy medication and nothing was getting rid of this. The rash and hives started after he got the injections too. The patient was scarred up from all of the scratching he did, even in his sleep and that they changed detergents and filtered the water they use for bathing. They was using baby laundry detergent. He just recently started on blood pressure medication and Lipitor. He was not on any medication prior to the event. His Cholesterol was at 200 and he was taking metoprolol because his blood pressure was creeping up. It was reported that, causality unknown, but stated that it was possible.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Onset same day of swelling - pain (R) arm. Woke still swollen. Refusing Tx and MD.
Seriousness criteria other medically significant (OMIC). Initial report received from a health care professional on 5/5/2006. A 58 year old male patient with a medical history of hypertension and hyperlipidemia had received injections of IPOL< Menomune ACYW and YF Vax on 4/24/2006. The lot numbers, routes and sites of administration were not reported. Six days post vaccination the patient developed a fever of 103 degrees F, manic episodes, hyperactivity, insomnia, a racing mind and began talking a lot. The fever lasted for three days, and the other symptoms persisted. The patient was scheduled to follow up with an infectious disease specialist. At the time of this report, the patient had a mild to moderate improvement in his signs and symptoms, but had not recovered.
Patient ID: MRN:  Name:  Age: 54 y.o. Birthday:   Admit Date: 8/1/2022  1:29 AM Discharge Date:  8/2/22 Unit:  Admitting Physician:  Discharge Physician:  DO   Discharge Diagnosis: Principal Problem:   Abdominal pain       HPI: Patient is a 54 y.o. female with a history of DM, HTN, HLD, and anxiety presents to the ED from home with complaints of worsening epigastric abdominal pain for 2 days. Pt states she has not been able to tolerate foods for approximately 5 days. Pt reports this pain is similar to the pain that she had in the past when she was diagnosed with gastroparesis but worse. Pt reports she follows with Dr. Pt tested postive for COVID 19 on 7/25 but states "this pain has nothing to do with the virus, I've had this before". Pt denies n/v, chest pain, or shortness of breath.      Hospital Course: Pt. Is a 54 year old female who was admitted to a HCF for severe abdominal pain/Epigastric pain.  She hadn't eaten well in severe days and felt that this was similar to when she had gastroparesis in the past.  Upon arrival, she received a CT abdomen and pelvis that showed only a mild hydronephrosis and signs of previous cystectomy as well as a an ileal loop diversion with the stoma of the ileal loop present within the right lower quadrant.  The patient felt much improved after IV fluid.. she is now hungry and ready to eat.  She states the GI doctor told her that all of her further workup would be done outpatient.  She is now stable at this time for DC with close F/U with PCP.                Physical Exam on the Date of Discharge: Physical Exam Constitutional:      Appearance: Normal appearance.  HENT:     Head: Normocephalic.     Nose: Nose normal.  Eyes:     Extraocular Movements: Extraocular movements intact.     Pupils: Pupils are equal, round, and reactive to light.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Pulses: Normal pulses.     Heart sounds: Normal heart sounds.  Pulmonary:     Effort: Pulmonary effort is normal.     Breath sounds: Normal breath sounds.  Abdominal:     Palpations: Abdomen is soft.  Musculoskeletal:        General: Normal range of motion.  Skin:    General: Skin is warm and dry.  Neurological:     General: No focal deficit present.     Mental Status: She is alert.  Psychiatric:        Mood and Affect: Mood normal.        Behavior: Behavior normal.              Consults:   IP CONSULT TO GASTROENTEROLOGY       Disposition:  home   Discharge Condition:  good
Narrative: COVID infection following COVID vaccine series 02/19, Pfizer, dose #1 03/15, Pfizer, dose #2 08/25 pt cc: chills, cough, fever, rhinorrhea exposure: unknown 08/25 COVID swab, result: detected 08/25 SARS-COV-2 Variant Sequencing result; pending
Facial numbness 782.0: Vs occult abscess 2nd to recent tooth pulling and malodorous breath, doubt that HPV, TDaP, MCV is responsible for numbness of face but will report to VAERS.  Otherwise remainder of exam wnl.
Pt recv vax on 10/20/98; on 10/21/98 pt exp fever (101.8 PO); pt seen by M.D.-tx=Medrol Dose Pack;exp swollen, red, hot Rt arm x 4dy
Heart is fluttering; Feeling that the room is rotating/Cannot move the head; Feeling sick the entire day; Sweating; Cannot drink water; Stomach is like killing her; Felt like the vaccine gave her a flu; Shaking; Cannot drink water; Tingling in the hand and toes; Chills; Vomiting; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Heart is fluttering) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, the patient experienced CARDIAC FLUTTER (Heart is fluttering) (seriousness criterion medically significant), VERTIGO (Feeling that the room is rotating/Cannot move the head), MALAISE (Feeling sick the entire day), HYPERHIDROSIS (Sweating), DYSPHAGIA (Cannot drink water), ABDOMINAL DISCOMFORT (Stomach is like killing her), INFLUENZA LIKE ILLNESS (Felt like the vaccine gave her a flu), TREMOR (Shaking), PARAESTHESIA (Tingling in the hand and toes), CHILLS (Chills), VOMITING (Vomiting), NAUSEA (Nausea) and WATER POLLUTION (Cannot drink water). At the time of the report, CARDIAC FLUTTER (Heart is fluttering), VERTIGO (Feeling that the room is rotating/Cannot move the head), MALAISE (Feeling sick the entire day), HYPERHIDROSIS (Sweating), DYSPHAGIA (Cannot drink water), ABDOMINAL DISCOMFORT (Stomach is like killing her), INFLUENZA LIKE ILLNESS (Felt like the vaccine gave her a flu), TREMOR (Shaking), PARAESTHESIA (Tingling in the hand and toes), CHILLS (Chills), VOMITING (Vomiting), NAUSEA (Nausea) and WATER POLLUTION (Cannot drink water) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use information was not provided by reporter.  Treatment medication use information was not provided by reporter.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
pt recv vax 20OCT95 & 6DEC96 pt exp a mild generalized rash;
Pain with injection, soreness swelling same day after few hours, redness spreading over last 3 days, allergies in arm, BENADRYL in pm, KEFLEX, leaving town today so f/u MD if not improving or worsening.
She got really sick after the second dose; Said cause of death was her heart; She had lost 60 lbs; Winded / difficulty breathing; Unable to walk; By the time she passed away, she was not able to eat much; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 83-year-old female patient received BNT162b2 (BNT162B2), in May2021 as dose 2, single (Lot number: EW0153) at the age of 83 years for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Had issues with her heart five years ago" (unspecified if ongoing); "Did a stent about 5 years ago" (unspecified if ongoing). Patient never got Covid. The patient took concomitant medications, including a lot of mediation for high blood pressure, antidepressants; taking six medicines by the time she died. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EN6203), administration date: Apr2021, when the patient was 83 years old, for Covid-19 immunization. The following information was reported: ILLNESS (death, hospitalization), outcome "fatal", described as "She got really sick after the second dose"; CARDIAC FAILURE (death, medically significant), outcome "fatal", described as "Said cause of death was her heart"; WEIGHT DECREASED (medically significant), outcome "unknown", described as "She had lost 60 lbs"; DYSPNOEA (non-serious), outcome "unknown", described as "Winded / difficulty breathing"; GAIT INABILITY (non-serious), outcome "unknown", described as "Unable to walk"; FEEDING DISORDER (non-serious), outcome "unknown", described as "By the time she passed away, she was not able to eat much". The patient underwent the following laboratory tests and procedures: Weight: had lost 60; over 200; probably around 250, notes: before getting the vaccines. The patient date of death was 01Nov2021. Reported cause of death: "She got really sick after the second dose", "Heart failure". No autopsy was performed.  Clinical course of events: The reporter believes that the patient's death was in regards to the second Covid-19 vaccine. Within two weeks of taking the second dose, patient was winded, unable to walk, and had difficulty breathing. The patient never had trouble walking before, but her legs became completely useless. In another couple of weeks, she had lost 60 lbs. She was a pretty heavy woman and started losing weight rapidly. By the time she passed away, she was not able to eat much. They were just giving her water and putting ice on her lips. After she got sick, she was hospitalized numerous times. She was getting so sick. She was admitted to the hospital and had a stay in a nursing home. Felt bad, so had her bought back home from the nursing home and a week after that she passed away in the house. She was hospitalized like three times. Unsure of the dates. Never took an autopsy. Doctor said cause of death was her heart. Doctor came to that conclusion without an autopsy. Heart failure was put on the death certificate.; Reported Cause(s) of Death: Heart failure; She got really sick after the second dose
This is a spontaneous report from a contactable Pharmacist. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced swelling at the injection site week after the injection on an unspecified date with outcome of unknown.
12 days post immunization, red, non-pruritic rash, patchy 4-5mm irregular papules with confluence at torso, cheeks. Cleared in 48 hours with steroids and Zyrtec.