chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had the 2 shingles shots, got the shingles/Suspected vaccination failure; had shingles, right side, up right breast, over shoulder, down back, down back of right arm and armpit; Itching burning pain; burning pain; feels like bugs crawling under and on top of skin; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: had the 2 shingles shots, got the shingles/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: had shingles, right side, up right breast, over shoulder, down back, down back of right arm and armpit), pruritus (Verbatim: Itching burning pain), pain burning (Verbatim: burning pain) and formication (Verbatim: feels like bugs crawling under and on top of skin). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the pruritus, pain burning and formication were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus, pain burning and formication to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pruritus, pain burning and formication to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 01-March-2023 This case was reported by a patient via interactive digital media. The patient received the 2 shingles shots and had 2 months interval between the 2 shots at a year ago,  The patient have had shingles for the last 2 months, physician said it's my nerves, shingles was horrible, feels like bugs crawling under and on top of skin, itching burning pain, have it only on right side, up right breast, over shoulder, down back, down back of right arm and armpit.  The patient was on valtrex 2 weeks when it began and nothing helps. The physician reported that got shots you can still get shingles. The follow up would not possible, as no contact, details were available. This case was considered as vaccination failure since the details regarding laboratory confirmation of shingles were unknown at the time of reporting.
Swollen and tender lymph nodes. First noticed a large knot a few inches below my left clavicle. It was tender to touch and painful if I raised my arm above my head. It was as large as a quarter at times and visible. Had some tenderness and tightness in my left arm pit as well as behind my left knee. The node near my clavicle was noticeably swollen for two weeks. Tenderness and pain went away after a week. Arm pit pain was about a day. And back of the knee for about three days.
2 1/2 hours, post vax, pt began crying inconsolably. Mom noted swelling at right thigh administration site. She brought baby in. Swelling continued to increase. Cold compresses applied to area; 3" diameter, warm, tender and central bruising between site of 2 injections. No temperature.
Tingling and numbness in right big toe and up the foot.  Sometimes sharp pain when touched.
I developed lower right quadrant abdominal pain, nausea, loss of appetite, weight loss that last ~6 weeks
headaches; fever; stomach issues; throwing up; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headaches"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; ABDOMINAL DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "stomach issues"; VOMITING (non-serious) with onset 2021, outcome "unknown", described as "throwing up"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "sick".  Follow-up attempts completed. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was unknown. It was unknown if the reporter considered the injection site swelling to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The reporter made a call with the patient. Referred caller back to health care professional if symptoms persist. The reporter did not provide any additional information regarding adverse event before ending the call.
Client had respiratory distress and dizziness after receiving vaccine, epinephrine was administered and respiratory distress resolved. Client was transported to hospital by EMS.
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 34-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (The patient used to have alcohol occasionally.). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 12-Dec-2020 and the estimated date of delivery was 14-Sep-2021. On 12-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirteenth week of the pregnancy.  On 12-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Pregnancy test: positive (Positive) Positive. On 13-Feb-2021, Therapeutic procedure: normal (normal) Noninvasive prenatal testing was done and genetic testing was normal.. On 11-Mar-2021, Ultrasound abdomen: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided by the reporter.  The patient gave twice live full term birth on 03-Mar-2016 and 02-Feb-2019.   The estimated date of conception was reported as 20-Dec-2020. The patient had no maternal history of subfertility and had established prenatal care. There was no complications or acute illness reported during tis pregnancy. Number of fetuses was reported as 1.   This case was linked to US-irms-MOD21-111429 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Reporter address details added; Sender's Comments:  US-irms-MOD21-111429.
1 ml was accidentally administered to patient instead of .5ml.  Patient has no reaction at this time.
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 16-NOV-2015, the patient was vaccinated with an improperly stored PNEUMOVAX 23 10 PK, lot # L002310, expiration date 08-JUL-2016, at a dose of 0.5 ml, (route and anatomical location of administration were unspecified). The vaccine underwent a total temperature excursion, of 1992 hours. The lowest recorded temperature was 27 Fahrenheit degrees (-2.777777778 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown), in right arm for COVID-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing); "Scleroderma" (unspecified if ongoing); "Pulmonary fibrosis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid from 14Aug2023 to 18Aug2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
CHILLS; SEVERE PAIN IN UPPER RIGHT LEG; slight headache; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included upper right leg pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) .5 ml, administered on 09-MAR-2021 03:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced chills, slight headache, and severe pain in upper right leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, slight headache and severe pain in upper right leg was not reported. This report was non-serious.
Onset approx 24 hours following vaccine for COVID.  All over urticaria, symmetric on all extremities, buttocks and a little on trunk. No oropharyngeal swelling, dyspnea, angioedema, or other severe symptoms. Treating with Benadryl and Pepcid. Deferred steroid treatment for now.
5/22/08 Pt seen well visit received Hep A/varicella/MMR. About 12 hrs after vaccines pt dvpd redness of face and arms swelling of eyelids, puffy face and hands when he awoke in the morning. No difficulty breathing. Mom gave a dose of BENADRYL with decreased swelling of eyelids.
Information has been received from a Doctor of Pharmacy concerning a patient who, on an unspecified date, was vaccinated with a dose of PNEUMOVAX 23 (lot # 664864/1365Y, expire date not reported), 0.5 ml, intramuscularly. After immunization with PNEUMOVAX 23, the patient developed rash, pain and numbness of the arm. This patient also reported difficulty moving that same arm. The arm affected was the arm that this patient received PNEUMOVAX 23. The patient sought medical attention by telephone call. At the time of the report, the outcome of the patient was unknown. The pharmacist requested a lot check. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 664864/1365Y were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports from the same source. Additional information is not expected.
Pain in joints and muscles, tingling on all extremities, chills, fever over 100 F, tearing up, nausea.
Patient experienced syncope following MCV vaccination. Was lying down with no injury, monitored for 15 minutes. Vital signs were stable.
Patient with nausea and vomiting.  Patient received her influenza shot earlier today and she may be having mild to moderate side effects.  Educated mother about vaccine side effects.  Repeat exam shows soft, non-tender abdomen. Patient tolerated POs in ED without difficulty. Refer to outpatient PMD follow-up in 1 day.  Return to ED sooner for worsening symptoms.  Doubt other emergent condition such appendicitis, colitis, obstruction etc.  Strict return precautions given.
Baby awakened 1-3 times each night from 1/5/01 to 1/18/01 with high-pitched screaming, difficult to console. Exam normal on 1/22/01.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: EK9231), in right arm, on 13Jan2021 as dose 2, single (Lot number: EL3246), in left arm and on 19Oct2021 as dose 3 (booster), single (Lot number: EW0217) at the age of 54 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "mitral valve repair" (unspecified if ongoing), notes: mitral valve prolapse with regurgitation (s/p mitral valve repair); "hx of atrial fibrillation" (unspecified if ongoing); "ADHD" (unspecified if ongoing). The patient did not have any known allergies. Concomitant medication(s) or other medications the patient received in 2 weeks included: LISINOPRIL, start date: 01May1994; ADDERALL, start date: 30Apr2020; ASPIRIN [ACETYLSALICYLIC ACID], start date: 04Sep2012; GABAPENTIN, start date: 07Mar2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 06Jun2022 to 11Jun2022. The initial COVID-19 symptoms completely resolved while the patient was on Paxlovid, but then she had rebound symptoms (cough, myalgia, headache, fatigue) 5 days after end of Paxlovid treatment. They had been improving, but mild cough persisted.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.
He had a prickly feeling all around his trunk. Felt like shingles, but not at a single nerve bundle. It was all around his chest and back of both arms; Felt like someone was pulling on every one of his body hair fibers, very uncomfortable; This is a spontaneous report received from contactable reporter (Other HCP). The reporter is the patient.  A 58 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administered in arm left, administration date 19Jan2022 10:00 (Lot number: FJ8757) at the age of 58 years as dose 3 (booster), single for COVID-19 immunization. Relevant medical history included: "Treating High Cholesterol" (unspecified if ongoing); "repaired atrial flutter" (unspecified if ongoing). Concomitant medications included: SIMVASTATIN; MONTELUKAST; ASPIRIN 81. Vaccination history included: BNT162B2 (Dose Number: 2, lot number: EW0172, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 07May2021, when the patient was 58 years old, for COVID-19 immunization; BNT162B2 (Dose Number: 1, lot number: ER8737, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 03Mar2021, when the patient was 57 years old, for COVID-19 immunization. The following information was reported: PARAESTHESIA (non-serious) with onset 21Jan2022 16:00, outcome "not recovered", described as "He had a prickly feeling all around his trunk. Felt like shingles, but not at a single nerve bundle. It was all around his chest and back of both arms "; DISCOMFORT (non-serious) with onset 21Jan2022 16:00, outcome "not recovered", described as "Felt like someone was pulling on every one of his body hair fibers, very uncomfortable". Therapeutic measures were taken as a result of paraesthesia, discomfort, which included ibuprofen 800 mg.
Arm hurt; Back was hurting worse than it ever did; Sensations going through her body; Had strange feelings in her body; Bones ached; She was so nervous; Joint pain; Chills; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), BACK PAIN (Back was hurting worse than it ever did), PARAESTHESIA (Sensations going through her body), FEELING ABNORMAL (Had strange feelings in her body) and BONE PAIN (Bones ached) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety. Concomitant products included FUROSEMIDE, METOPROLOL and RIVAROXABAN (XARELTO) for an unknown indication.   On 20-Mar-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurt), BACK PAIN (Back was hurting worse than it ever did), PARAESTHESIA (Sensations going through her body), FEELING ABNORMAL (Had strange feelings in her body), BONE PAIN (Bones ached), NERVOUSNESS (She was so nervous), ARTHRALGIA (Joint pain), CHILLS (Chills) and FATIGUE (Felt tired). The patient was treated with ALPRAZOLAM for Anxiety, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm hurt), BACK PAIN (Back was hurting worse than it ever did), PARAESTHESIA (Sensations going through her body), FEELING ABNORMAL (Had strange feelings in her body), BONE PAIN (Bones ached), NERVOUSNESS (She was so nervous), ARTHRALGIA (Joint pain), CHILLS (Chills) and FATIGUE (Felt tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
My left arm so sore could not use it .. the lower arm muscle was swollen and enlarged and felt sprained.. I could not straighten arm without incredible pain hurting.. got very nauseous could not eat and very very tired.. unable to sleep through the night pain in body resulted in fetal position crying. Leg muscles very weak and I was light headed. Cannot touch left arm.
Has a rash on the inside of my leg about an hour after, this one disappeared quickly. I then developed a rash on my arm about 10/11 days later, also developed a rash on my face.  The rashes were itchy and stayed for about a week. The one on my face was raised bumps, the one on my arm looked more like a flat red sore area. Kinda like hives except flat, not raised. (the one on the arm).
First two days after vaccine- tired. By day three began experiencing back pain. By Wednesday, January 20th severe back pain and chest tightening. I went first to Urgent Care. Dr. said EKG ok but I should follow up with Dr. or ER. That evening I went to ER at Hospital. By then it felt like my back and chest were in vice. It did not feel like regular back pain- more searing and deep spasms. Had a gnawing kind of feeling in my stomach and esophagus. Pain in upper part of my body....sometimes waves of pain in shoulders and down back half of my arms. ER Dr gave me shot of pain meds and sent me home after a few hours. Vice like feeling subsided but deep muscle pain in back continued.It was not as severe as the previous day. Over the next week it continued to go from severe back to mild.I visited my primary care Dr/PA and tried changing GERD meds from Famotidine to another- no help. Tried muscle relaxers- I just slept on those. About a week after first visit I went to ER again after a bad night of the vice like feeling in chest and back. ER Dr. did CAT scan of heart and lungs. No sign of pneumonia . Since then I have had an endoscope, seen a cardiologist, and an orthopedic Dr.  After second dose, reaction came back, but less severe than the first time.
Weak; Chills; Headache; Body ache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Body ache) and FATIGUE (Fatigue) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Spinal stenosis (Lesion in cervical spine) and Eye disorder (Blood vessel bulging in the eye). Concurrent medical conditions included Hypothyroidism, Environmental allergy, Asthma, Hypertension (High blood pressure), Depression and Rheumatoid arthritis.    On 02-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 ASTHENIA (Weak), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Body ache) and FATIGUE (Fatigue). At the time of the report, ASTHENIA (Weak), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Body ache) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not reported.  No treatment information were reported.   Reporter did not allow further contact
She reports headache, fatigue, nausea, diarrhea and intermittent facial flushing.  She had photo sensitivity yesterday (8/18/2021) .  She now has numbness that radiates from her back up her neck whenever she sits down.
Pt recvd Hepatitis B vax & following 3rd dose pt exp edematous fingers & arthralgias of the low back & knees; @ the time of the report pts condition persisted; no further details were provided;
Soreness at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 27-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 VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-336820, MOD-2021-344336 (Patient Link).
Upper arm pain when pulling clothes off overhead, difficulty rolling over in bed when using arm for leverage, treated with naproxen.