chrisvoncsefalvay/vaers-outcomes huggingface dataset:
stomache cramp; diarhea; ache at injection sight; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomache cramp), DIARRHOEA (diarhea) and INJECTION SITE PAIN (ache at injection sight) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomache cramp), DIARRHOEA (diarhea) and INJECTION SITE PAIN (ache at injection sight). At the time of the report, ABDOMINAL PAIN UPPER (stomache cramp), DIARRHOEA (diarhea) and INJECTION SITE PAIN (ache at injection sight) outcome was unknown.        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.   Treatment information include : drank 7up and took an antacid. No relevant concomitant medications were reported.
This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Lack of drug effect) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product UPADACITINIB (RINVOQ) for an unknown indication. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, DRUG INEFFECTIVE (Lack of drug effect) had not resolved. No concomitant medications were provided by the reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. All doses of vaccine including booster were given one in once. It was reported that the patient did not see a lot of help with it. No treatment information was provided. The reporter's causality for the event of Rinvoq was not working with Rinvoq (Upadacitinib) was a reasonable possibility. Company Comment: This spontaneous case concerns an elderly, female patient who received the co-suspect product Rinvoq (upadacitinib) for an unknown indication and also received the third (booster) dose of the mRNA-1273 vaccine on unspecified dates. On an unknown date, it was reported that the patient did not see a lot of help with Rinvoq and it was not working. The event drug ineffective was reported and the mRNA-1273 vaccine was also considered as a suspect product. No further details were provided. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns an elderly, female patient who received the co-suspect product Rinvoq (upadacitinib) for an unknown indication and also received the third (booster) dose of the mRNA-1273 vaccine on unspecified dates. On an unknown date, it was reported that the patient did not see a lot of help with Rinvoq and it was not working. The event drug ineffective was reported and the mRNA-1273 vaccine was also considered as a suspect product. No further details were provided. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
A report was received from a health professional on 10/23/02, concerning a 2 year old male vaccine who was inadvertently administered Fluvirin vaccine on 10/23/02. The vaccinee experienced no adverse reaction. There was insufficient information to determine the reporter's causality assessment.
On Monday, Dec 13th, pt noticed (L) arm - deltoid area sore, red, warm, itchy and firm from injection site to approx 4" below. Because the discomfort increased, pt. called her physician. Her doctor recommended TYLENOL, BENADRYL and warm compresses to area. Pt took TYLENOL but not BENADRYL. Applied heat to area as per her doctors instructions. On Tuesday, Dec 14th patient experienced persistent discomfort (L) arm with area of redness, warm, itching et tightness now extending from 2" below (L) shoulder down to left elbow. She called her physician who recommended she be evaluated. Pt saw MD on 12/14/10 at 6:15pm. Pt reported that her physician gave her an IM injection of what she thinks was an antibiotic and told her to start Cefadroxil orally the next day. He also prescribed Diclofenac orally which pt started Tuesday evening. On Wednesday, Dec 15th, pt called our Health Center to report incident. (L) arm today she reports is still red, itchy, tight, sore but not as firm as Dec 14th. Area involved remains down to left elbow and pt states had spread to undersurface of left upper arm. She also reported approx. 40 small fluid filled "welts" scattered in an "S" formation one inch from injection site down anterior surface of arm. I advised patient to call her physician to report her symptoms and for further recommendations. Pt acknowledged my advice and will call her physician.
patient described experiencing "flu" like symptoms of full body aches and low grade fever beginning evening after immunization and continuing the day after
A consistent, dull, strained ache in my left arm at the vaccine site affects some movement in that arm.; A consistent, dull, strained ache in my left arm at the vaccine site affects some movement in that arm.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Jan2021 12:45 (Lot number: EL3248) at the age of 49 years as dose number 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: IBUPROFEN. Vaccination history included: Bnt162b2 (Brand=Pfizer, Lot number= EJ1686, Lot unknown= False, Administration date=30Dec2020, Vaccine location=Left arm, Dose number=1), administration date: 30Dec2020, when the patient was 49 years old, for covid-19 immunisation. The following information was reported: MOBILITY DECREASED (non-serious), VACCINATION SITE PAIN (non-serious) all with onset Feb2021, outcome "not recovered" and all described as "A consistent, dull, strained ache in my left arm at the vaccine site affects some movement in that arm.". Therapeutic measures were not taken as a result of mobility decreased, vaccination site pain.  Additional information: Facility type vaccine was the workplace clinic. Patient did not have covid prior to vaccination. Post vaccination patient did not have Covid. Patient did not have any known allergies.   No follow-up attempts are needed. No further information is expected.
11/26/22 presents to ED for "fatigue, respiratory distress". PMHx of "aortic stenosis asthma A. fib CAD CHF CKD COPD hypertension hypothyroidism"
This spontaneous report as received from a licensed vocational nurse refers to an unspecified patients of unknown age and gender. There was no medical history, drug reactions/allergies and concomitant medication provided. On an unknown dates, the unspecified patients were vaccinated with an improperly stored doses of RECOMBIVAX HB (dose, route, lot#, therapy type and expiration date were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
9 days after vaccine pt stated severe vertigo and dizziness that required hospitalization for 7 hours.  Dr. stopped levothyroxine.  As of 11.2.23 symptoms have not resolved-
Interchange of vaccine products; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (pregnant) received bnt162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: FR8730), in left arm and on 16Apr2021 as dose 2, single (Lot number: FR8735) at the age of 32 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Nov2021 as dose 3 (booster), single (Lot number: 021C21A), in left arm for covid-19 immunisation. Date of last menstrual period: 24Aug2023. The patient was 8 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 30May2024. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (17Oct2023) and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Positive; (17Oct2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300336044 same reporter/patient with different drug/AE;US-PFIZER INC-202300336168 same reporter/patient/drug with different AE;
Information has been received from a physician concerning a patient (age and gender not reported) who on an unspecified date was vaccinated with ROTATEQ. Concomitant medications were not reported. Subsequently on an unspecified date, the patient experienced intussusception and was hospitalized. Subsequently on an unspecified date, the patient recovered from intussusception. Additional information has been requested.
Back of right arm became red and swollen. Went from a lump size of a small plum to a size of an orange. Skin was red and warm to the touch. Seen by school nurse-ice applied, administered Tylenol, and applied Caladryl Anti-Itch Cream beacause she c/o of itching at the injection site. Patient also complained of nausea for 24 hours. No fever.
Achy legs/arms/back. Runny nose, flu symptoms chest felt rapid heart beat/strong heart beat.
Patient started with rash and pruritus, that started in both hands and then disseminate trough all body and face.  Pruritus got worst as time passed.  The patient visited a medical office and an emergency room at the Hospital.  A week after symptoms continues (dermatitis over skin and some pruritus, even with the use of antihistaminic).
19 mo child received vaccination on 6DEC89 developed H. Influenza Meningitis on 4DEC90.
This case was reported by a other health professional via call center representative and described the occurrence of injection site rash in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site rash, injection site erythema, erythromacular rash, fever and chills. On an unknown date, the outcome of the injection site rash, injection site erythema, erythromacular rash, fever and chills were unknown. It was unknown if the reporter considered the injection site rash, injection site erythema, erythromacular rash, fever and chills to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a receptionist. The age at vaccination was not reported. The health care professional reported that the patient experienced a red rash at the injection site, described as red spots. The health care professional declined to provide any additional information. This is 1 of the 4 cases reported by the same reporter.
Patient came in for an influenza vaccination and pneumonia vaccination. During the injection, I counseled patient about possible side effects from the vaccines (mild cold, soreness of arm for a few days). Before patient was injected, I told her to hang her arm to the side so that the muscles in her arm were completely relaxed. I explained to the patient that when giving vaccines, hanging the arm to the side is the most relaxed position from my experience. As I injected the influenza vaccine using proper techniquie, the patient tensed up her left arm and then pulled back while the needle was in her arm. I said to the patient not to tense up or pull back because the needle was in her arm and if her arm was tense she would feel more pain. The vaccine was injected. I put the bandaid on and then the patient switched chairs. Patient left the store. We received a phone call at around 7:20 pm. Patient spoke with one of the technicians, with whom she complained. Patient was asking if she needed to get the second dose of the pneumonia shot in the same arm and mentioned that she never was asked to hang her arm to the side before to relax her arm. The technician then put the patient on hold because he wanted to confirm with the pharmacist the answers to her questions. As the pharmacist, I picked up the phone and the patient told me that she did not want to speak with me. I asked her if there was something I could help her with and she said that she has never been asked to hang her arm to the side when getting injections and that her arm hurt. She did not elaborate on what she meant by hurt. She said that I should ask other pharmacists how they give vaccinations. I explained to her that this was the way I was trained and I have watched many videos about injection technique and through experience I feel that having the patient hang their arm to the side is the best position so their arm is completely relaxed. I apologized and explained that I have never had someone complain. I apologized and explained again that in my experience that is the best way to have a relaxed arm so patients are not in pain and patient hung up.
Narrative:  COVID infection following COVID series 06/14, MODERNA, dose #1 09/15, MODERNA, dose #2 11/03 ESR: 50 11/03 pt cc: exposure: unknown 11/03 COVID swab, result: detected 11/04 SARS-COV-2 Variant Sequencing result: pending 11/04 LACTIC ACID: 1.23 11/04 SARS-COV-2 TOTAL AB, SPIKE: >2500.0 11/04 COVID swab, result: not detected 11/04 SARS-COV2 IgG: 6.23 11/04 CTA PE impression: 1. No evidence of pulmonary embolus. 2. Old granulomatous disease. 11/04 CXR impression: Despite the clinical history of COVID, I do not see definite abnormal pulmonary parenchymal opacities. If clinically indicated, perhaps correlation with CT might be helpful for further assessment. 11/05 clinically resolved 11/05 ESR: 80 11/05 PROCALCITONIN: 3.05 11/05 FIBRINOGEN: 491 11/05 DDIMER: 0.41 11/06 PROCALCITONIN: 1.85 11/06 ESR: 77 11/16 ESR: 59 11/16 SARS-COV-2 IgG: 6.24 11/16 SARS-COV-2 IgG: 6.24 11/16 ESR: 59
Initial report was received 18 August 2010 from a healthcare professional. An adult female patient (age not reported) had received an injection of FLUZONE SV, lot number U216EA during 2006 (lot number invalid; route, site and exact date of administration not reported) and an unspecified amount of time later, she developed a swollen mouth, swollen lips and a red streak from the injection site down the arm. An unspecified amount of time later, the patient recovered. Documents held by sender: None.
4/16 - rash, lip swelling, tongue pain, temperature, chills, body aches, lymphadenopathy,  4/23 - chest pain (same day as cortisone injection) 4/24 - worsening swelling, pain with swallowing 4/25 - admitted to the hospital through the ED with erythemic rash to bilateral palms, bilateral feet, back; painful, not itchy; eye red; lip swollen; tongue pain and pain with swallowing
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ace inhibitors allergies" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "recovered" (Jul2023) and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 10Jul2023 to 15Jul2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
right after injection, left deltoid became itchy. Patient took own Benadryl and Tylenol. Left to go home in stable condition.
Warm to the touch, itchiness, hives "everywhere", no respiratory distress. Rash occurred 45 min after receiving vaccines. DTaP...
pt recv vax;hurt in area of shot; few days later, was having sharp pain in arm and up into shoulder;has not seen MD;
Syncope immediately after receiving vaccination. Patient slumped over and lost consciousness for approximately 5 seconds. Patient had no memory of what happened once he woke up.
Rash Itchyness  On face, neck, arm, shoulder, chest, lower arm, back  (Upper and Lower)
typical fever, nausea, chills, body aches, ear ringing commenced the day after the vaccine and lasted for 3-4 days. the ear ringing never stopped.
patient report swelling size of a lemon on the left collar bone, but NO pain.  Patient received COVID  shot on the left arm.   This is the 2nd booster shot (4th dose total).  Patient never experienced this type of reaction before.
w/in 15min of vax pt devel an inj site rxn characterized by redness, warmth, & tenderness;pt devel gen hives, treated self w/oral DPH & recovered;this is 1 of 3 employees of this facility to have adverse exp p/vax;
11/20/17- 4:15 pm - Had Nausea and Diarrhea. For the next two days couldn't sleep more than 3 hours each night and had night sweats, hot flashes and increased heart rate. On day three took KLONIPIN 0.25mg to sleep. Pt states it took 10 days for symptoms to subside.
Patient was administered concentrated covid pfizer dose. Technician did not dilute according to package directions/
Information has been received from a doctor of pharmacy concerning a female patient over 65 years of age. On approximately 09-AUG-2012, the patient was vaccinated IM with a 0.5 ml PNEUMOVAX 23 IM (lot # and expiration date were not reported) and "yesterday", on 23-AUG-2012, the patient received the second 0.5 ml dose of PNEUMOVAX 23 (lot # and expiration date were not reported). It was reported that the patient received the two doses of PNEUMOVAX 23 two weeks apart. There were no adverse effects reported. Additional information has been requested.
Initial tissue  reaction with erythema to us change,  swelling, and pain  on injected site and place, left arm has not subsided even in 6 weeks duration. Second  shot on the rt. arm didn?t cause any problem.  No warm sensation on injection site. She feels heavy on lifting her left arm and pain on motion of left arm above injection site.  She has used arm sling to support lt. arm and took Advil occasionally, but no help. No fever elicited. I am very curious . Not sure what specialty dr to take her for further assessment. Similar repoRt?
Patient called 7/15/21 to report that she will not be getting the second dose due to experiencing blisters of the upper lip that spread to her nose. She spoke with her provider and was instructed to take Benadryl, which she said did help. The provider recommended against getting the second dose. The blistering has since resolved.
minor headache; He got his COVID19 booster yesterday; He got his COVID19 booster yesterday; This is a spontaneous report from a Pfizer sponsored Program reported by contactable Other HCP. A 65-year-old male patient received BNT162b2 (COVID-19 VACCINE; Lot Number: not reported), via an unspecified route of administration on an unspecified date (at the age of 65 years old) as DOSE 3 (BOOSTER), SINGLE DOSE for COVID-19 immunisation. Medical history included Diarrhea from unknown start date and unknown if ongoing and mild dizziness from 28Sep2021 and unknown if ongoing. Concomitant medications were not reported. Historical vaccines included first and second dose of BNT162b2 (COVID-19 VACCINE; Lot Number: unknown), via an unspecified route of administration on an unknown date (at the age of 65 years old) as single dose for COVID-19 immunisation. The patient experienced a minor headache after third dose of BNT162b2 on an unspecified date. The patient received treatment for the events with tylenol. The outcome of the event was considered as resolving.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Fever, headache, joint pain and stiffness, muscle pain and fatigue lasting more than 1 day.
It was twelve days after my vaccination I developed a rash on the arm that was vaccinated. It was hot and itchy on my upper arm. It was a large oval shape red swollen area. I went to see the dermatologist who said he had had several patient who had a similar dermatologic reactions. He called it a delayed reaction gave me cream Cortisone cream and it cleared up within 48 hours.  Second dose did not have a similar reaction. I had the same reaction as my sister who had the same muscle and joint aches in the same areas
Patient felt a little tired but also feels tired all the time due to underlying condition; This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (Patient felt a little tired but also feels tired all the time due to underlying condition) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Drug-induced lupus erythematosus ((resolved by December)) in December 2020. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included PROPRANOLOL, LEFLUNOMIDE, FOLIC ACID, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), PROBIOTICS NOS and METHOTREXATE for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced FATIGUE (Patient felt a little tired but also feels tired all the time due to underlying condition). On 31-Dec-2020, FATIGUE (Patient felt a little tired but also feels tired all the time due to underlying condition) had resolved.        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.   Additional concomitant medications include ArthroStop Infusion and Certex.  No treatment information was provided.   This case was linked to MOD-2021-273123 (Patient Link).
Chills, fever, headache. No treatment. Chills, fever lasted about 8 hrs. Headache lasted 12-14 hrs.
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with unspecified number of improperly stored RECOMBIVAX HB (dose and route not provided) (lot number #K016005, expiration date: 27-AUG-2016; lot number #L003193, expiration date: 10-NOV-2016). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.