chrisvoncsefalvay/vaers-outcomes huggingface dataset:
discomfort; swelling about an inch or so below injection site; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (discomfort) and VACCINATION SITE SWELLING (swelling about an inch or so below injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concomitant products included Betablocker, medicine for eye: Lutein, MULTIVITAMINS & MINERALS PLUS LUTEIN, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and Heart med for an unknown indication.  On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 20-Jan-2021, the patient experienced DISCOMFORT (discomfort) and VACCINATION SITE SWELLING (swelling about an inch or so below injection site).   At the time of the report, DISCOMFORT (discomfort) and VACCINATION SITE SWELLING (swelling about an inch or so below injection site) 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.
Patient called today and said she developed a cluster of blood blisters on her left wrist & left breast after receiving the 2nd dose on 2/6/2021
Burning/stinging on elbow of the injection site arm. No visible marks on elbow. Also sore if I lean on it. Not knowing what it was I put Vaseline on it last night. This morning I had red streaks going from my elbow towards my hand. Now, several hours later, the red has disappeared and my elbow no longer seems sore. I just thought I should report in in case there is a cataloguing of different effects.
Sore, red, itchy rash on skin around injection side. Large circle around injection site.  On day after vaccination (11/15/22) experienced chills, muscle pan, extreme fatigue.
swelling on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (swelling on the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Reported.     On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE SWELLING (swelling on the injection site). At the time of the report, INJECTION SITE SWELLING (swelling on the injection site) had not resolved. Not Provided
Sudden, explosive attack of diarrhea the day of the shot (THU 1/21), followed almost immediately by extreme fatigue, muscle soreness, some light headedness and nausea, and the injection site was sore. I had a rapid heartbeat all night and could not sleep. I spent the next day (FRIS 1/22) in bed with the same symptoms.  Then I developed chills and sweats. It is now.Saturday, and I feel slightly better, but still very, very tired. My arm where I got the shot is very sore still.
Administered 3 vaccines. After last injection which was HPV patient stated he was light headed. He immediately became unresponsive for 5-10 seconds. Patient was laid down on exam table during this time. After becoming responsive again the patient was given juice and crackers. These were tolerated. Physician and attending were notified. Patient was monitored in clinic.
Approximately 2 hours after receiving the vaccination patient noted raised red rash which covered upper back with no breaks in the rash.  It was very itchy and covered an area approximately 10 inches across and 7 inches down.
Swollen and erythematous left thigh at site of immunization-involved entire thigh.
received a third dose of Shingrix in error; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 49N3S, expiry date 24th August 2023) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 12-AUG-2022 Reporter's Comments: The patient received a third dose of Shingrix in error. The reporter was not asked about follow-up. Additional Supportive Information: The patient received 3rd dose of Shingrix, which led to extra dose administered.
About 30 minutes after vaccine, strong headache on left forehead,  left arm and hand felt funny (tight, strange sensation), left shoulder and neck was tight/sore/aching, and left cheek/face felt tight - strange sensation, left jaw was tight and joint was popping (happens when I get dental fillings).  I could feel a tight strange sensation on the left side only - could tell it was not crossing my midline, no strange sensation on my right side at all. I still had feeling and movement on the left side but, felt really weird and tight- similar to the feeling after a dental filling anesthesia is wearing off. Weird sensation wore off by evening. Arm was sore for 3 days.  9 days after vaccine outer areas of breast were very sore and at 10 days felt a lump under right armpit.   Developed hives on both forearms 12 days after vaccine. Had headaches on and off for one week. Had fatigue for about 4 days.
got extremely itchy, saw rash in middle of night. Took benedryl liquid. Next 2-3 days had heavy rash and hives.
Information has been received from a physician referring to two 18 month old male twin patients. There was no medical history or drug reaction/allergies reported. On 24-MAR-2016, the two patients were inadvertently administered with GARDASIL (lot # L040459 with expired date 06-APR-2017, intramuscular, dose unknown) into their thighs. No concomitant therapy was reported. No adverse effect was reported. Additional information has been requested.
This was NOT an adverse event.  It was a vaccine administration error.  We thought we were administering the Pfizer bivalent vaccine and discovered in the mid afternoon on 9/8/22 that we were actually administering the Pfizer Grey Cap (monovalent/original) formulation of the vaccine.  Upon discovery corrective action was taken.  Patient was notified of vaccine administration error as was the local Department of Health.
Pain at injection site / went to the ER the same day / is now feeling fine; Body aches / went to the ER the same day / is now feeling fine; Fever / went to the ER the same day / is now feeling fine; This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a patient who received Men B NVS (Bexsero) (batch number ABXB06DA, expiry date unknown) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st February 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 2nd February 2021, 1 days after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site pain, general body pain and fever. On an unknown date, the outcome of the injection site pain, general body pain and fever were recovered/resolved.   It was unknown if the reporter considered the injection site pain, general body pain and fever to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. Patient had adverse events on the second day On 2nd February 2021, patient experienced side affects were body aches, fever and pain at injection site.  Patient went to the emergency room  the same day.  The patient is now feeling fine. The reporter consent to follow up.
no adverse effect; improperly stored vaccine administered; This spontaneous report was received from a medical assistant regarding a patient of unknown gender and age. Information on pertinent medical history and drug reactions/allergies were not reported. On 30-APR-2019, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), lot# R020678 with expiry date of 15-JAN-2020, for prophylaxis (dose, route of administration was not reported) (Product storage error). The patient had received properly stored Merck sterile diluent. No additional adverse effects were reported. Temperature was reported as (32.57 F) 15 degrees Fahrenheit to 45 degrees Fahrenheit. Time frame was 22 hours. There was no previous temperature excursion. The call was due to data logger. There was no product quality issue (PQC).
Information has been received from a health professional concerning an adult pt who was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy included prednisone, 6 mg. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow up information from a health professional indicated that 7 days post vaccination with varicella virus vaccine live the pt experienced one day of not feeling well. The pt did not have a fever or a rash. It was reported that the pt recovered. Additional information has been requested.
Swollen and painful lymph nodes on left side above my collar bone as well as under my left arm pit. Also swollen lymph nodes in my neck.
low white blood cell; low neutrophil count; 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 WHITE BLOOD CELL COUNT DECREASED (low white blood cell) and NEUTROPHIL COUNT DECREASED (low neutrophil count) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced WHITE BLOOD CELL COUNT DECREASED (low white blood cell) and NEUTROPHIL COUNT DECREASED (low neutrophil count). At the time of the report, WHITE BLOOD CELL COUNT DECREASED (low white blood cell) and NEUTROPHIL COUNT DECREASED (low neutrophil count) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Neutrophil count: low (Low) Low. On an unknown date, White blood cell count: low (Low) low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.
Patient did not have adverse reaction.  Rather, she said that her shot was mistakenly administered SQ instead of IM.  She said that her arm "hurt, so [she] knows it went SQ".  The administrator's technique was reassessed and determined to be appropriate for IM .  Patient said she contacted the CDC and they instructed her NOT to repeat the vaccination.
Fatigue; sleeps all the time; headache; muscle aches; arm soreness; warm; pinkish; Little swollen below the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), SOMNOLENCE (sleeps all the time), HEADACHE (headache), MYALGIA (muscle aches) and PAIN IN EXTREMITY (arm soreness) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CENTRUM VITAMINTS for Immune disorder (NOS), TAMSULOSIN for Prostate, GLUCOSAMINE and VITAMIN C [ASCORBIC ACID] for an unknown indication.  On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced FATIGUE (Fatigue), SOMNOLENCE (sleeps all the time), HEADACHE (headache), MYALGIA (muscle aches), PAIN IN EXTREMITY (arm soreness), VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (pinkish) and VACCINATION SITE SWELLING (Little swollen below the injection site). At the time of the report, FATIGUE (Fatigue), SOMNOLENCE (sleeps all the time), HEADACHE (headache), MYALGIA (muscle aches), PAIN IN EXTREMITY (arm soreness), VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (pinkish) and VACCINATION SITE SWELLING (Little swollen below the injection site) outcome was unknown.      Treatment for the events: None.
Patient had a swollen red arm below injection site about 4 inches in diameter still seen after 1 week post vaccine. She complained of pain level 7 out of 10.
I have  a bumpy reddish itchy  rash on both arms & hands. Also a small patch on my right knee. It occurred a few weeks after receiving my vaccine. Please note I do spend a lot of time outdoors & could of come into contact with something. Just saying I have a decent rash going on. I didn?t need medical treatment. I simply apply  hydrocortisone cream
Red, itchy eyes with yellow pus, sore throat, sore muscles, cough. Got antibiotic eyedrops
Patient was given a booster shot of Moderna at 15 yo, before the age in the guidelines.
RED, SWOLLEN LEFT THIGH, TENDER TO TOUCH, STARTING APPROX 15-20 HOURS AFTER INJECTION.
Side effects; This case was reported by a consumer and described the occurrence of adverse event in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced side effects. The patient asked how long would the side effects typically last. This case was identified as duplicate of US2019AMR185012. The case US2019AMR185012 was deleted and all the future correspondence was added in the present case which stands as case of record for this patient.
nausea; vomiting; chills; joint and muscle pain; joint and muscle pain; headache; fatigue; This is a spontaneous report from a contactable consumer (patient).  A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration, at the age of 26-year-old, on an unspecified date, at SINGLE DOSE for COVID-19 immunization.  The patient medical history was not reported.  There were no concomitant medications. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) on an unspecified date, single dose for COVID-19 immunization. On an unspecified date, following administration of second COVID-19 vaccine, the patient experienced nausea and vomiting, chills, joint and muscle pain, headache, and fatigue. Onset of symptoms occurred approximately 5 hours after administration of medication and became progressively worse over the next 20-24 hours following administration of dose. Symptoms began to resolve around 26 hours post administration of medication. Outcome of the events was recovering at the time of the report.  No follow-up attempts are possible. Information about batch number cannot be obtained.
9/24-9/26 Slight fever, 9/29-10/10 slow progressing nasal congestion, 10/12-10/15 severe cough, 10/14 went to ER and confirmed asthma which she never had.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient was vaccinated with a 0.65 ml dose of ZOSTAVAX. The route and lot number were not provided. No other co-suspects were reported. No concomitant medications were reported. On an unknown date a couple of days after vaccination, the patient came back to pharmacy with redness on the arm and some warmth to the touch. The patient did not seek medical attention. No treatment information was reported. The outcome of redness on the arm and some warmth to the touch was reported as recovering/resolving. The relatedness for redness on the arm and some warmth to the touch was unknown for ZOSTAVAX. Additional information has been requested.
Persistent high blood glucws values without change in diet or exercise.  Fasting >120 consistently.  Last AIC 6.8 Feb 2021  Increased short acting insulin from 35 to 60 units per day.  Increase is managing BG
Patient 9 year old female was administered Pfizer today afternoon. The patient developed a panic attack and complained of nausea, stomach tightness, and weakness. The patient forehead turned purple which was clearly visible to staff and pharmacist. Patient requested to  use the rest room and could not hold on any longer. The pharmacist carrying an EpiPen followed the patient accompanied by a female clerk to the rest room at the back of the store. Mother said she cannot come to the restroom as her second child had received the vaccine and is waiting for 15 minutes to pass so that they can go home. The patient used the restroom and said she is felling better. The mother said her daughter has previously suffered panic attacks. The patient color was back to normal and informed the pharmacist that she feels ok now. The pharmacist called the mother at home at 4:45 pm to check on the patient. Mother informed the Rph that she is doing well and thanked for the follow up call. The mother was requested to make online appointment three weeks later for the second shot.
Having symptoms associated with rheumatoid arthritis and fatty liver; Having symptoms associated with rheumatoid arthritis and fatty liver; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 43-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization.  The following information was reported: RHEUMATOID ARTHRITIS (medically significant), HEPATIC STEATOSIS (non-serious), outcome "unknown" and all described as "Having symptoms associated with rheumatoid arthritis and fatty liver". It was unknown if therapeutic measures were taken as a result of rheumatoid arthritis, hepatic steatosis.  Clinical Course: Reporter  told that a 43-year-old woman reported having symptoms associated with rheumatoid arthritis and fatty liver after having received the COVID-19 vaccine. The report is second hand through a friend who is her counselor. I've shared the reporting website with the counselor and have urged her to share it with the woman who has been experiencing the symptoms. Patient was recovered or not: unknown. If patient had  COVID prior vaccination: Unknown. If patient was COVID tested post vaccination: Unknown. If patient had received treatment: unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
therapeutic effect unexpected.; sinuses; joint pain; This is a spontaneous report from a contactable consumer or other non hcp. A 90-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EL9261; Expiration Date: 31May2021)via unspecified route of administration, administered in Arm Left on 22Jan2021, as dose 1, single for covid-19 immunisation. The patient Medical history included ongoing arthritis. The patient's concomitant medications were not reported. The patient said that she had arthritis. The patient said that with the first dose, the patient experienced sinuses and joint pain, that were cleared up faster. The patient stated that her left ear feels clogged up and it cleared up faster which led to therapeutic effect unexpected.The patient clarified that she had arthritis on her right side with her hips and shoulder and stated that the joint pain was still there and it was still quite sore. The clinical outcome for sinuses and joint pain (Arthralgia) was recovered on an unspecified date. The clinical outcome of the other event therapeutic effect unexpected was unknown.  Follow-up attempts completed. No further information expected.
This spontaneous report was received from a healthcare worker, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored M-M-R II Lot # L020188 with expiry date on 03-JUN-2017, (strength, dose, route and anatomical location not reported). No adverse effect was reported and no product quality complaint was reported. Temperature: 9 Celsius degrees. Time frame: 40 hours. Was it administered (AE)? Yes. Previous temperature excursion? No. Was call because of a "data logger"? No. This is one of several reports received from the same reporter. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild
Information has been received from a licensed practical nurse referring to unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On unspecified dates the unspecified patients was vaccinated with doses of improperly stored PNEUMOVAX 23 (lot # K020214, expiration date 25-MAR-2016) (dosage, strength and route were not reported). There was no concomitant medication reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
In July I started with knee pains. Both knees were hurting and had some swelling. Then notice my lymph nodes swollen around my neck. Then my both elbow start hurting and swelling. My finger starts falling asleep then it moved to my arms. I went to the doctor and they took MRI and blood work. They sent me to physical therapy. My blood work was fine and my therapist don't understand why I was like this.
Pt recv vax on 10/29/98; on 11/01/98 pt exp nausea &vomiting, stomach cramps, fever (99-100), headache, sore throat, weak &dizzy
Site: Pain at Injection Site-Mild, Additional Details: he feel dizyy , he was talking to us , ask and was replying I asked and he said he was able to breath normaly. we offer to call 911 he said yes then after 3 minutes he said he feels better donot need 911 but that time 911 team was next to him. they took over
Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 13-Mar-2021, the patient experienced PAIN (Body aches). At the time of the report, PAIN (Body aches) had not resolved.            No concomitant medications were reported. Treatment information was not provided.   This case was linked to MOD21-053588 (Patient Link).