chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developed Shingles after the initial dose; 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 HERPES ZOSTER (developed Shingles after the initial dose) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (developed Shingles after the initial dose). At the time of the report, HERPES ZOSTER (developed Shingles after the initial dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Treatment information was not provided.
Chest pain found to be myopericarditis, initially treated with NSAIDS, then readmitted for pericarditis and treated with NSAIDS and Colchicine (intolerate to colchicine) and readmitted for pericarditis being treated with high dose ASA and low dose colchicine.
about 24 hours later, I started feeling chill, tire and rash on my stomach, feel itchy on my back but very small area. Rash got spread out little by little as day go by, and the chill and tirdness are the same.  Rash spread my whole from but not the breast area and the part of the back , my inner upper arm and inner thigh but not a big area.  I went to see doctor on the 5 of March and doctor give me Hydroxyzine to take.
Pt came to clinic requesting booster for COVID vaccine. Cards were lost in past. Temp staff gave patients pfizer paperwork for boosters.  Nurse requested that staff look patients up on ImmTrac to make a complete card. After pfizer was given staff staff informed nurse they had received other 2 doses of Covid vaccine had been Moderna. Pts were monitored 20 min no adverse symptoms.
Mild symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Mild symptoms) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Mild symptoms). At the time of the report, VACCINATION COMPLICATION (Mild symptoms) outcome was unknown.            Concomitant medication use was unknown Treatment information was unknown
Received a booster of Pfizer/BioNTech vaccine on December 27. On Day 8 after receiving the booster, I had a flare of rheumatoid arthritis, specifically severe low back pain and pain in my feet and feeling "flu-ish". I have documented rheumatoid arthritis in my spine and in my feet. Pain lasted 3 days and resolved. I had a similar reaction to this year's flu shot, which I received in late September 2021 -- on Day 8 after the flu shot, I also had severe back pain for several days and pain in my feet. I am a medical professional and have read over and over that vaccines do not cause a flare of RA. This is untrue in my experience. About a week after every vaccine I've received (including flu shots and 3 COVID-19 shots) is have a significant RA flare.
FOC called 9/2/09. States child had possible adverse RXN 3 days after vaccination on 8/28/09. Client # 972517, had spike a fever 99 to 101    . Relieved by MOTRIN and an occasion of febrile SZ. FOC states child u/hx of febrile Sx at 19 mos. Plan to follow up u/PMD scheduled for 9/3/09. States went to PMD 9/3 @ Clinic QC states child Ok now 9/8/09 on follow up call.
abdominal pain , treated for a UTI ~2 weeks ago and finished her antibiotic course,
localized swelling, hive appeared after injection was given, along with redness around hive.
Redness 2 inches below the injection site; This case was reported by a nurse via call center representative and described the occurrence of erythema in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 44T97, expiry date 18th September 2023) for prophylaxis.   On 3rd November 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 8th November 2022, 5 days after receiving Shingrix, the patient experienced erythema. On an unknown date, the outcome of the erythema was not recovered/not resolved.   It was unknown if the reporter considered the erythema to be related to Shingrix.     Additional Information: GSK Receipt Date: 09-NOV-2022 Reporter's comments: Nurse reported that the patient received her first Shingrix dose in the right deltoid and experienced redness 2 inches below the injection site.  Nurse stated that the redness area was about 10 centimeter by 7 centimeter in size. Nurse stated she was unsure whether this redness was caused by Shingrix vaccine administration or something else.  The reporter consented to follow up.
p/vax pt broke out in a chickenpox rash w/approx 10 lesions located on chest, legs, & scalp;pt sought unspecified medical attention;
shingles; This spontaneous report as received from a lawyer and the patient (pt) refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant medication were not reported.  On or about 29-AUG-2011, the pt was vaccinated by the physician with a dose of zoster vaccine live(ZOSTAVAX), (Dose, route, lot number and expiration date were not provided) for for the long-term prevention of shingles and zoster-related conditions. Subsequent to vaccination, the pt was treated by a a physician in the medical Office for shingles. As a direct and proximate result ofvaccination with zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Noticed a ringing in my ears 10 minutes after vaccination and tinnitus like symptoms are not improving the day after.
- DIFFICULTY BREATING, ANGIOEDEMA, BURNING/PAIN THROUGHOUT BODY, LOW O2 SAT - PT WAS GIVEN 0.3MG EPI 1:1000 VIA EPI AUTO INJECTOR PEN - PT VITALS IMPROVED
2 days after vaccine developed weakness of legs then arms.  MRI cervical and thoracic spine most consistent with Transverse Myelitis; Transverse Myelitis; This is a spontaneous report from a contactable physician. A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 at single dose for COVID-19 immunisation. The patient was not pregnant at Time of Vaccination. Facility type vaccine was Hospital. Medical history included hyperlipidemia, hypothyroid. The patient's concomitant medications were not reported. No Other vaccine in 4weeks. Days after vaccine on 22Jan20212, the patient developed weakness of legs then arms. MRI cervical and thoracic spine most consistent with Transverse Myelitis. AEs resulted in Hospitalization, Disability or permanent damage. The patient was recovering. IV steroids, physical therapy was received as Treatment. No covid prior vaccination. No covid tested post vaccination.   Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Approximately 12 hours after the shot developed very severe aching. Was that most of the night with aching. Treated with alternate courses of acetaminophen and ibuprofen. Approximately 6:00 a.m. the morning after the shot, or about 20 hours, developed very strong tinnitus, ringing of the ears.
vaccination site began itching; vaccination site began  soreness and hurting; rash; pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), RASH (rash), VACCINATION SITE PRURITUS (vaccination site began itching) and VACCINATION SITE PAIN (vaccination site began  soreness and hurting) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029120A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure, Cholesterol, Arrhythmia (Heart Rhytm) and Clot blood (Blood clots). Concomitant products included FLECAINIDE for Arrhythmia, OLMESARTAN for Blood pressure, ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, APIXABAN (ELIQUIS) for Clot blood, TAMSULOSIN HYDROCHLORIDE (TAMSULOSIN +PHARMA) and METOPROLOL.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 02-Jan-2021, the patient experienced PAIN (pain). On 09-Jan-2021, the patient experienced RASH (rash). On 17-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (vaccination site began itching) and VACCINATION SITE PAIN (vaccination site began  soreness and hurting). On 05-Jan-2021, PAIN (pain) had resolved. On 17-Jan-2021, RASH (rash) had resolved. On 19-Jan-2021, VACCINATION SITE PRURITUS (vaccination site began itching) and VACCINATION SITE PAIN (vaccination site began  soreness and hurting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment given was normal ointment Other medical condition also included prostate; 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.
Patient was administered 0.5 cc Influenza vaccine IM R deltoid at 12 noon, returned to clinic site 1320 c/o rash itching on R hand/wrist and bilateral on lower jaws. Instructed him the call family physician, go home, take Benadryl. Patient had no overt symptoms of respiratory distress.
Student stated he felt "woozy". Laid down x 10 minutes and ate crackers. Stated he felt better and resumed class.
Left deltoid with redness and swelling. Pt denied pain. Instructed to apply ice pack to site, and continue with Motrin. may follow up if injection site becomes worse.
First injection  5/26/2021 - no adverse effects; no soreness - nothing. Second injection 6/16/2021 - no adverse effects; no soreness - nothing.  I've had many injections of the years; (1969-70) and was given many injections;    (2008-15) and had more injections.  The injections were sometime sore but nothing more.
pt recv vax & devel a rash, fever & ear sx; LPN felt that there was a problem w/the particular lot vax;
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Headache-Medium, Systemic: Nausea-Severe
Severe vomiting, lethargy, excessive sleepiness, diarrhea, excessive awakeness, dehydration, loss of appetite.
Marked erythema, induration, around injection site 5.5 x 6 in; scattered papules diaper area.
Local reaction to Tdap vaccine. Injection site swollen and very warm, tender to the touch.
Headache achiness Narrative:  employee states: she began symptoms of: achiness, warmth, headache for about 12 hours with taking advil every 6 hours
dermal fillers in my lips on 02Nov2021 i had extreme pain swelling, and significant bruising.; dermal fillers in my lips on 02Nov2021 i had extreme pain swelling, and significant bruising.; dermal fillers in my lips on 02Nov2021 i had extreme pain swelling, and significant bruising.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27May2021 14:45 (Lot number: Ew0172) at the age of 30 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL taken for attention deficit hyperactivity disorder. Past drug history included: Amoxocillan, reaction(s): "Known allergies: Amoxocilan", notes: Known allergies: Amoxocillin. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0172, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 06May2021, when the patient was 30 years old, for Covid-19 immunization, reaction(s): "Injection site pain", "Fever", "upset stomach"; Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0172, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 06May2021, when the patient was 30 years old, for COVID-19 immunization, reaction(s): "Cough". The following information was reported: CONTUSION (non-serious), LIP PAIN (non-serious), LIP SWELLING (non-serious) all with onset 02Nov2021 23:30, outcome "recovering" and all described as "dermal fillers in my lips on 02Nov2021 i had extreme pain swelling, and significant bruising.". The event "dermal fillers in my lips on 02nov2021 i had extreme pain swelling, and significant bruising.", "dermal fillers in my lips on 02nov2021 i had extreme pain swelling, and significant bruising." and "dermal fillers in my lips on 02nov2021 i had extreme pain swelling, and significant bruising." was evaluated at the physician office visit. Therapeutic measures were taken as a result of contusion, lip pain, lip swelling.  Additional Information: Facility type vaccine: Pharmacy or Drug Store Facility country: No other vaccine in four weeks. After receiving each dose patient was sick for 3 days with a fever, cough, and upset stomach with intense pain in the injection site that traveled up her neck and down her left side. She couldn't move her neck completely but the side effects subsided after day three. 2. Patient received dermal fillers in her lips on 02Nov2021 she had extreme pain, swelling, and significant bruising. Taking an antihistamine helped to reduce the pain and swelling the following day. AE treatment: Advised to take antihistamine. Patient had Covid-19 prior vaccination. Patient was not tested post vaccination.   Follow-up attempts are completed. No further information is expected.
Felt dizzy; Had some diarrhea this morning; Her joints are more sore than usual; Had some nausea; Had a headache; Had a bit of a sore arm; Went to bed early as she felt tired; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Felt dizzy), DIARRHOEA (Had some diarrhea this morning), PAIN IN EXTREMITY (Had a bit of a sore arm), FATIGUE (Went to bed early as she felt tired) and ARTHRALGIA (Her joints are more sore than usual) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7163B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Lasted for about 5 or 6 days, like a minor cold) on 10-Sep-2022. Previously administered products included for Product used for unknown indication: Pfizer (Dose 1, lot number:EJ3002) on 17-Jan-2021, Pfizer (Dose 2, lot number:EJ3002) on 05-Feb-2021, Pfizer (Dose 3 and lot number: FJ1620) on 29-Nov-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Arthritis.    On 22-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 22-Sep-2022, the patient experienced PAIN IN EXTREMITY (Had a bit of a sore arm) and FATIGUE (Went to bed early as she felt tired). On 23-Sep-2022, the patient experienced DIZZINESS (Felt dizzy), DIARRHOEA (Had some diarrhea this morning), ARTHRALGIA (Her joints are more sore than usual), NAUSEA (Had some nausea) and HEADACHE (Had a headache). At the time of the report, DIZZINESS (Felt dizzy), DIARRHOEA (Had some diarrhea this morning), PAIN IN EXTREMITY (Had a bit of a sore arm), FATIGUE (Went to bed early as she felt tired), ARTHRALGIA (Her joints are more sore than usual), NAUSEA (Had some nausea) and HEADACHE (Had a headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2022, SARS-CoV-2 test: (Positive) Tested positive by home test.. In September 2022, SARS-CoV-2 test: just had 1 bar, grayish color, on at home test kit. Was told that is because the virus is leaving the body..         No concomitant medication were reported.  It was reported that the Modera bivalent COVID-19 vaccine are more severe than when caller had the pfizer COVID-19 vaccine.  No treatment medications were taken for her symptoms after she received the Moderna vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 26-Sep-2022: Live follow up received on 26-Sep-2022. Patient demography, relevant history, lab data were updated.
Brain fog, confusion, fever (101), headache, light headedness, fatigue, imbalanace.
coughing a lot while talking; tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing a lot while talking) and COVID-19 (tested positive for COVID-19) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Nov-2021, the patient experienced COUGH (coughing a lot while talking) and COVID-19 (tested positive for COVID-19). At the time of the report, COUGH (coughing a lot while talking) and COVID-19 (tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Nov-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported. Treatment information was unknown.  Company comment: This case concerns a 58-year-old male patient, with no medical history reported who experienced non serious unexpected AESI of COVID-19 after third dose of mRNA-1273. The patient reported having received a primary series scheme with mRNA-1273 vaccine (first dose date not provided) and two days after third dose he test positive for COVID-19. The re-challenge is not applicable due to the nature of the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 58-year-old male patient, with no medical history reported who experienced non serious unexpected AESI of COVID-19 after third dose of mRNA-1273. The patient reported having received a primary series scheme with mRNA-1273 vaccine (first dose date not provided) and two days after third dose he test positive for COVID-19. The re-challenge is not applicable due to the nature of the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated  (Oka/Merck) VARIVAX dose 1, (dose, lot # and expiry date unknown). On 13-JUN-2012, patient received improperly stored (Oka/Merck) VARIVAX dose 2, from lot # 671861-1907AA expiry date: 05-DEC-2013. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received form the same reporter. Additional information has been requested.
After 23 hours of getting the injection I started experiencing pain around and in my heart.This went on for a few days util I went to my cardiologist. It was determined that I was affected by the moderna injection.
Histamine reaction 2 hours after injection and still present at 15 hours from injection: itchy runny nose, post-nasal drip, mild itchiness around body (torso, arms, ears, head), Left ear pain on side of injection . Took 50mg benadryl at bedtime and this morning took 10mg claritin and 10mg syngulair.
Feeling very down, like very tired.; Feeling very down, like very tired.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Nov2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEPRESSED MOOD (non-serious), FATIGUE (non-serious) all with onset 03Nov2023 at 18:00, outcome "unknown" and all described as "Feeling very down, like very tired.".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Information has been received from a physician concerning his 54 year old wife with allergy to sulfa drugs like Bactrim and no pertinent medical history who on 20-AUG-1998 was vaccinated with the first dose of PNEUMOVAX. Concomitant therapy included Premarin and Zyrtec. On 20-AUG-1998, after receiving the vaccine, the patient developed neck and shoulder pain, she found it was difficult to swallow and had chest tightness. Her lower back had pressure pain/discomfort when she attempted to lie down at the office. When she sat up, she had flushing and her face and chest was red. She was given a Solumedrol injection. It took about 30 minutes until the symptoms resolved. No lab tests were done. The reporting physician considered the events to be other important medical events. Additional information has been requested.
Acute chest pain lasting for 2.5 months. Loss of feeling in left arm and leg for 1 full day after vaccine was administered. Brain fog for rough 1 month.
Spoke with mom & she reports the day after vaccines got a red-raised rash on bil thighs. Denies fever. Also had rash after 2nd set of vaccines.
Monday night of vaccine got extreme chills, muscle aches, joint aches. Woke up with a fever of 100.8. Very fatigue. Pounding headache and fatigue all day Tuesday on 1/5/2021. Tuesday night I felt better and was able to get some energy back. Tuesday morning woke up with sore throat. Around 9am got extremely tired and laid down. Started wheezing, throat starting itching and I started coughing. Called on call nurse at health center and they advise me to go to hospital to get checked out. Went to hospital. They gave me Benadryl and prednisone for my symptoms. Kept me for 30 minutes and I fell asleep. Was discharged and prescribed prednisone for the next 5 days if symptoms persist. My diagnosis was adverse drug reaction.