chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported; "over the age of 15 weeks" received their first dose of ROTATEQ.; This spontaneous report was received from a nurse referring to a 4-month-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 07-DEC-2022 (over the age of 15 weeks), the patient received the first dose of rotavirus vaccine live, pentavalent (ROTATEQ) (2 ml/once; strength, anatomical location, lot#, and expiration date were not reported) orally for prophylaxis (product administered to patient of inappropriate age). No adverse event was reported.
Kidneys not working properly; Elevated Blood pressure 170/? mmHg; Feeling of being Wiped-Out; Creatinine Clearance Levels went up to 2.2 mg/dl; This spontaneous case was reported by a health care professional and describes the occurrence of RENAL IMPAIRMENT (Kidneys not working properly) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypertension and Kidney function abnormal.    In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced RENAL IMPAIRMENT (Kidneys not working properly) (seriousness criterion medically significant), BLOOD PRESSURE INCREASED (Elevated Blood pressure 170/? mmHg) and MALAISE (Feeling of being Wiped-Out). On an unknown date, the patient experienced BLOOD CREATININE INCREASED (Creatinine Clearance Levels went up to 2.2 mg/dl). At the time of the report, RENAL IMPAIRMENT (Kidneys not working properly) and BLOOD CREATININE INCREASED (Creatinine Clearance Levels went up to 2.2 mg/dl) had not resolved and BLOOD PRESSURE INCREASED (Elevated Blood pressure 170/? mmHg) and MALAISE (Feeling of being Wiped-Out) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement (100/70-140/90 mmHg): 170/?? mmHg 170/??. On an unknown date, Creatinine renal clearance increased (0.6-1.1 mg/dl): 2.2 mg/dl 2.2 mg/dl.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications not reported. Treatment was not reported.; 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.
Dizziness, throat closing up. was given Benadryl 25mg IM per EMS and symptoms resolved
Pt came today 10/09/2015 about 6:30PM and said she has big red rash not painful but rash, pt will check with Dr.
Two days after My second Dose of the Pfizer Covid-19 Vaccine I began to show signs of impaired cognitive ability, difficulty standing,  and irregular gait while walking.  Four days after My second dose of the Covid vaccine I lost all ability to stand and had no sense of feeling in my legs or feet I also had very severe cognitive issues. I was told I have guillian Barre Syndrom.
Patient is unable to lift her left arm. The arm hurts and is extremely tender to the touch.
Joint Pain, initially started primarily in pinky knuckle on Day 2 and each day progressed to additional knuckles on right hand until I could not make a fist at 4th day. Progressed to left hand and other joints (knees) by 4th day. Use of acetaminophen helped alleviate  pain and permitted more movement.   By day 6,  pain  reduced to no longer need medication. As of Today,  joints are still not back to normal still slightly tight. Injection site was sore for 5 days.
Patient immediately fainted upon receiving vaccine. Came to, then fainted and "seized up" before coming to again. We called 911 and an EMT came and did a patient assessment and determined patient could return home with father and no hospital visit was required. Vitals had returned to normal.
Within 18 hours, I developed a fever, fatigue, and severe body ache as expected from previous doses. Managed with Tylenol for two days. Inflammation and fatigue still continues three weeks later. Labs drawn a week after (10/17/23)  revealed elevated EBV early antigen D AB (IGG)  and hsCRP  levels, suggesting reactivation of EBV.
Narrative:  66yo female patient with- PMH: Code Description M79.673 Foot pain (SCT 47933007) M54.5 Chronic low back pain (SCT 278860009) G89.29 Chronic pain (SCT 82423001) K21.9 Gastro-esophageal reflux (SCT 235595009) N18.9 Abnormal renal function (SCT 39539005) R32. Urine incontinence (SCT 165232002) E11.9 Type 2 diabetes mellitus without complication (SCT 313436004) 296.32 Major Depressive Disorder, Recurrent, Moderate (ICD-9-CM 296.32) 309.81 PTSD (ICD-9-CM 309.81) 719.45 Hip Pain (ICD-9-CM 719.45) E78.2 Hyperlipidemia (SCT 55822004) J44.9 Chronic obstructive lung disease (SCT 13645005) 793.1 Multiple nodules of lung (ICD-9-CM 793.1) 702.8 Leukoplakia (ICD-9-CM 702.8) 194.9 Adrenal Gland Neoplasms (ICD-9-CM 194.9) 625.6 Urinary Incontinence, Stress (ICD-9-CM 625.6) 305.1 Tobacco user (ICD-9-CM 305.1) 296.20 MAJOR DEPRESSION (ICD-9-CM 296.20) I10. Hypertension (SCT 38341003) V49.73 Amputation Status of the Foot (ICD-9-CM V49.73) 237.70 Neurofibromatosis (ICD-9-CM 237.70) died at hospital of unknown cause. Pt had received covid vaccines on 6/30/21 & 7/31/21 at pharmacy. This death is likely not related to the vaccinations due to patient's comorbidities and length of time from vaccine administration.
102.5 temp for 2 days so far, body convolutions, abdominal pains, headaches, body aches.
This spontaneous report was received from a registered pharmacist concerning to a 61 years old male patient. On 24-OCT-2012, the patient was vaccinated with the first dose of ZOSTAVAX Lot No. reported as H014366 (dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. Pharmacist reported that on 25-OCT-2012, the patient experienced rash post vaccination 2 x 2 inches in the arm. The patient was treated with cortisone cream. On 29-OCT-2012, rash was reported as recovered/resolved. The relatedness for the event was unknown for ZOSTAVAX. Additional information has been requested.
It started with a headache. I just felt really lousy. I was tired and I had low grade fever of 100 degrees. I was a little bit nauseous and generally tired. They really only lasted a day. I was prescribed PAXLOVID and that made me feel worse than the actual COVID-19.
c/o pains in neck on the lt side-went to bed, said it felt better to lie down;
Information has been received from a physician concerning a female who on unspecified date was vaccinated with 0.5 ml GARDASIL (lot # not reported) and fainted. Dose of series was unknown. Unspecified medical attention was sought. On unspecified date the patient recovered from fainting. No further information was provided. Additional information has been requested.
This spontaneous report as received from a healthcare worker (certificated medical assistant) refers to a patient of unknown age. On 10-NOV-2014 the patient was vaccinated with an expired dose of ZOSTAVAX lot # J000433, expired date: 10-APR-2014) 0.65 ml subcutaneously. There was no adverse experience. Additional information has been requested.
Facial swelling, redness, burning/pain started 24 hours after injection and has not resolved itself 9 days later. Other common reactions (nausea, joint pain, chills, fatigue) started at the same time, and have since mostly resolved itself except I'm still experiencing fatigue and tiredness.
Unable to Get Up; Body Aches; Fever; Chills; This spontaneous case was reported by a health care professional and describes the occurrence of MOBILITY DECREASED (Unable to Get Up), PAIN (Body Aches), PYREXIA (Fever) and CHILLS (Chills) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 039K20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced MOBILITY DECREASED (Unable to Get Up), PAIN (Body Aches), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, MOBILITY DECREASED (Unable to Get Up), PAIN (Body Aches), PYREXIA (Fever) and CHILLS (Chills) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  No concomitant medications reported by investigator  No treatment medications provided by the reporter.
COVID-19 infection symptoms started in med February 2023 probably in the afternoon. I had cough, headaches, post nasal drip, and achy. I did 2 home tests which were positive. I did a telehealth with my doctor who prescribed me with 2 different pills. I am not sure of the name exactly. I also take vitamin D along with the medications. As of now I still have the lingering cough from COVID-19 infection and my throat is more sensitive now.
Pt has pain and aching at the location where the vaccine was administered. No erythema or vesicle. This began 3-4 days after vaccination with Zostavax and continues today. Still very sensitive to the touch.
Information has been received from a Nurse Practitioner (N.P.) concerning a 63 year old female with hypertension, acid reflux and osteoporosis as well as penicillin allergy who on 11-MAR-2009 was vaccinated subcutaneously with a dose of ZOSTAVAX (Merck) (lot# 662855/1623X).  Concomitant therapy included alendronate sodium (NSD), atenolol, esomeprazole magnesium (NEXIUM) and "serltrazine".  The patient sought medical attention and was seen in the office on 17-MAR-2009 since she developed an injection site reaction.  There was redness, streaking and warmth starting at the injection site and working its was distally on the arm.  At the time of reporting (17-MAR-2009) the patient was not recovered.  Follow up information was received from the Nurse Practitioner (N.P.) by phone on 07-APR-2009 reporting that the patient was prescribed topical antibiotic ointment for the arm and she was getting better.  No further information is available.
On 8/30/12 redness, swelling, pain, warmth at injection sites (R) VARIVAX - 6" redness & warmth on 8/30; better 8/31 (L) Tdap & MENACTRA 1 1/2" - heart shaped, hot, hard, tired, 3 hr nap 8/30, low grade fever, tx with TYLENOL. 9/4/12 Arms did improve each day, but still were sore.
still was experiencing nausea; chills; fever of 101.5 degrees F; fatigue; nausea; This spontaneous case was reported by a health care professional and describes the occurrence of CHILLS (chills), PYREXIA (fever of 101.5 degrees F), FATIGUE (fatigue), NAUSEA (nausea) and NAUSEA (still was experiencing nausea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Anxiety, Celiac disease, Hypertension, Stress, Lipids increased, Osteopenia and Vitamin D deficiency. Concomitant products included SALBUTAMOL (ALBUTEROL HFA), FLUTICASONE, Wixela Inhaler, HYDROCHLOROTHIAZIDE, LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) and MONTELUKAST SODIUM (SINGULAIR).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 22-Jan-2021, the patient experienced CHILLS (chills), PYREXIA (fever of 101.5 degrees F), FATIGUE (fatigue) and NAUSEA (nausea). On 25-Jan-2021, the patient experienced NAUSEA (still was experiencing nausea). At the time of the report, CHILLS (chills), PYREXIA (fever of 101.5 degrees F), FATIGUE (fatigue) and NAUSEA (nausea) outcome was unknown and NAUSEA (still was experiencing nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Strong metallic taste in mouth; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 16Sep2021 09:15 (Lot number: FC3183) at the age of 28 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "sulfa drugs" (unspecified if ongoing), notes: sulfa drugs. Concomitant medication(s) included: CIPROFLOXACIN; AZO; WELLBUTRIN. The following information was reported: DYSGEUSIA (non-serious) with onset 16Sep2021, outcome "not recovered", described as "Strong metallic taste in mouth". Therapeutic measures were not taken as a result of dysgeusia.  Additional information: Facility type vaccine was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Immediately pain and constriction of heart and leg pain - almost dropped to my knees. Continued muscular impairment. Mottled skin. Pain down arms and legs. Still happening 5/8/13 with less intensity.
15 cm in length x 5 cm width cellulitis in (L) upper extremity.
is_pregnant: Yes; Mild headache; sore arm muscle around injection site; inexplicable pain in muscle on underside of upper arm, near armpit. Cannot extend arm fully, feels as if muscle is shortened or very tense/strained/muscle pain; This is a spontaneous report from a non-contactable consumer. This consumer reported information for both mother and fetus/baby. This is a maternal report. A 37-years-old pregnant female patient received bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 14Jul2021 14:00 as DOSE 1, SINGLE for covid-19 immunisation (Age at vaccination 37 year). Medical history included systemic lupus erythematosus, pregnancy, depression, anxiety. Concomitant medication(s) included hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), prenatal vita, D3. No other vaccine in four weeks. No covid prior vaccination. No Known allergies. No covid tested post vaccination. On 16Jul2021 20:45 patient experienced mild headache, sore arm muscle around injection site, inexplicable pain in muscle on underside of upper arm, near armpit. cannot extend arm fully, feels as if muscle is shortened or very tense/strained/muscle pain and patient was pregnent. The mother reported she became pregnant while taking bnt162b2. The mother was 18 Weeks pregnant at the onset of the event. The mother was due to deliver on 15Dec2021. The mother delivered the pregnancy on 15Dec2021. No treatment required for AE. The outcome for pregnancy was unknown for all other events it was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Feb2021 at 11:00 as dose 1, single (Lot number: el9269), in left arm, on 01Mar2021 at 11:00 as dose 2, single (Lot number: en6203), in left arm and on 05Nov2021 at 11:00 as dose 3 (booster), single (Lot number: fh8020) at the age of 74 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Feb2023) Negative, notes: Completed 5 day Paxlovid. Tested negative next three days; (07Feb2023) Negative, notes: Completed 5 day Paxlovid. Tested negative next three days; (08Feb2023) Negative, notes: Completed 5 day Paxlovid. Tested negative next three days; (09Feb2023) Positive, notes: Tested positive on day 4; (unspecified date) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment with Plaxlovid, from 01Feb2023 to 05Feb2023.
14th - Shot area hurting and red. Hard to move arm. 15th - Upper arm was swollen. 16th - Could move arm better. Swollen and 3/4 of upper back arm is red. 17th - could move arm fine. Less swollen. Can still feel hard area deep down.
Swollen and redness on left shoulder/ upper left chest/ left side of neck.  Currently being treated for cellulitis.  Prescribed Keflex and ibuprofen.
Information has been received from a physician concerning an 18 year old female, who on 21-JAN-2008 was vaccinated with a 0.5mL first dose of Gardasil (lot# 659439/1267U). On 22-JAN-2008 the patient developed an injection site rash. The patient sought unspecified medical attention. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested. Follow-up received 04/16/2008. Initial and follow-up information has been received by a physician concerning an 18 year old female, who on 25-OCT-2007 was vaccinated with a 0.5ml first does of GARISIL (Lot # 659439/1267U). There were no reactions reported after the first dose. On 21-JAN-2008 the patient was vaccinated with a second dose of GARDASIL. On 22-JAN-2008 within 24 hours of the second dose the patient developed an injection site rash, rash on her trunk, and swelling and redness at the injection site. The physician reported that there were no breathing problems or any reactions that would have indicated anaphylaxis. The physician spoke to the patient's mother in regards to the signs and symptoms reported. The patient was unable to come to the office for a visit until 28-JAN-2008. Over the next few days the patient experienced viral like signs and symptoms including a headache, stuffy nose, and intermitten fever. On 28-JAN-2008 the patient was seen at the office for viral like symptoms. It was reported that at the time of the office visit there was no rash. The patient recovered from the rash on an unspecified date. No product quality complaint was involved. Additional information is not expected.
"swimming" feeling in head -30 min after shot body aches  - 30 mins after shot  through day 1 Heart racing/palpitations - apx 7 hours after shot extreme exhaustion - 4 hours through day 1 chills - 30 mins through the end of day 0 (day of shot) gum pain - 30 mins through the end of day 0 (day of shot)
CLOSE TO DEATH AND WOULD UNDERGO 4 HEAVY OPERATIONS; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced close to death and would undergo 4 heavy operations. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of close to death and would undergo 4 heavy operations was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed as non-serious.
suspected vaccination failure; shingles / not as bad; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient.  The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication.  The patient received vaccine and still experienced shingles but not as bad. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles and time to event onset were unknown.
Headache, Myalgia, Arthralgia, exquistely sore injection site pain which lead to neck tension/ upper trap tension, chills, swetas, sore throat Narrative:
Fever, vertigo, headache, chills, increased heart rate, pain , redness and large lump at site of injection (upper arm).
Patient experience some dizziness, sleepiness, nausea, and feeling hot (called EMS and she was alert and oriented throughout the whole process). AMA and refused to go to the hospital.
When pushing the vaccine the needle burst off of the syringe. I think most of the dose was given, however I did get some vaccine splatter after this happened.
We received the following literature report on 15 JUN 2009: 15 children between 6 and 59 months of age were vaccinated for the first time with an influenza vaccine (batch no. and manufacturer unknown) at the start of each influenza season (defined from 01 NOV to 30 APR) from 1999-2000 through 2006/2007. The children received a total of two doses (fully vaccinated). Vaccine effectiveness among fully vaccinated children as compared with unvaccinated children was 86% (95% confidence interval: 29-97%) for medically attended, laboratory-confirmed influenza illness. Vaccine effectiveness for the partially vaccinated group was 73% (95% confidence interval: 3-93%) as compared with the unvaccinated group. This case refers to one child (for other children, please refer to reference cases MA2009-1692, MA2009-1708 to MA2009-1710, MA2009-1712 to MA2009-1714 and MA2009-1716 to MA2009-1722). Laboratory-confirmed influenza illness was reported (date?). Request was sent on 22 JUN 2009, no follow-up information received.
Patient called on 9/24, shot was given on 8/15. He stated the next week after the vaccine he had sensitivity to the skin and body/muscle pain. 8/26- he went to med express, and they thought he was having a reaction and told him to do MOTRIN for pain, and ALLEGRA for the allergic reaction he then stated he couldn't sleep for 4-5 days -he spoke with his family doctor and Dr. did not feel this was a reaction associated with the vaccine. On 9/24- he called to report for our records, and said the severe pain had gone away, but still has tingling at the injection site.
Pt reports severe muscle pain in left arm which started about 4 days after receiving vaccine.  Pt. states trouble getting dressed & rotating arm.  Pain severe enough to wake during the night.  Pt. denies treatment.