chrisvoncsefalvay/vaers-outcomes huggingface dataset:
red line that spread into her arm; Arm started to itch; Arm got swollen, circular, hardened; arm red; Arm got swollen, circular, hardened; Muscle pain; Itching in the arm; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE STREAKING (red line that spread into her arm), VACCINATION SITE PRURITUS (Itching in the arm), VACCINATION SITE PRURITUS (Arm started to itch), VACCINATION SITE INDURATION (Arm got swollen, circular, hardened) and VACCINATION SITE ERYTHEMA (arm red) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced VACCINATION SITE PRURITUS (Itching in the arm) and MYALGIA (Muscle pain). On 05-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Arm started to itch), VACCINATION SITE INDURATION (Arm got swollen, circular, hardened), VACCINATION SITE ERYTHEMA (arm red) and VACCINATION SITE SWELLING (Arm got swollen, circular, hardened). On 09-Jan-2021, the patient experienced VACCINATION SITE STREAKING (red line that spread into her arm). The patient was treated with IBUPROFEN on 09-Jan-2021 for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (BENADRYL LOTION N) on 05-Jan-2021 for Adverse event, at an unspecified dose and frequency. On 31-Dec-2020, VACCINATION SITE PRURITUS (Itching in the arm) had resolved. On 01-Jan-2021, MYALGIA (Muscle pain) had resolved. At the time of the report, VACCINATION SITE STREAKING (red line that spread into her arm), VACCINATION SITE INDURATION (Arm got swollen, circular, hardened), VACCINATION SITE ERYTHEMA (arm red) and VACCINATION SITE SWELLING (Arm got swollen, circular, hardened) was resolving and VACCINATION SITE PRURITUS (Arm started to itch) 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.   Concomitant medication 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.
28 YO previously health active duty male presented to my aid station approximately 2-3 hours after receiving immunization with chief complaint of "feeling puffy all over and being red." He denied chest pain or shortness of breath at that time. Upon exam he was remarkably edematous around his eyes, fingers and toes, with some extension proximally - his skin was erythematous in those areas, too. He was tachycardic to the low 110s and mildly hypertensive to 140s/90s. He denied any history of ingestion of new substances, drugs, insect bites, food allergies or drug allergies. I couldn't technically call his reaction anaphylaxis because he didn't have CP/SOB or evidence of hypotension, but I was worried about him progressing to that. I gave him 50 of IM BENADRYL, established a large bore PIV and gave him to liters of fluid, 50 mg oral hydroxyzine and 50 mg of oral prednisone and watched him in our aid station for 6 hours. His swelling improved remarkably, his tachycardia resolved and his blood pressure came down. He was monitored overnight by his battle buddies and appeared completely improved the next day in follow up with me.
Cough; Congestion; Fatigue; Aches; Loss of taste; Loss of smell; This is a spontaneous report from a contactable consumer. An adult non-pregnant female patient of unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 27Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient had received any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. On 28Sep2021, the patient experienced cough, congestion, fatigue, aches and loss of taste and smell. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events cough, congestion, fatigue, aches and loss of taste and smell was resolving at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Bumps on lips after both injections (cold sores)  Given Valacyclovir and Acyclovir - Cleared after 7 day  treatment  Left Breast Indentation/Hardness/Separation/tenderness - Sent for Mammogram/Ultrasound - Nothing showed on either test except swollen lymph nodes - return in 3 months for recheck.  Symptoms ongoing.  Other symptoms include more common sore arm, chills, rash arm, swollen lymph nodes, numbness, fatigue, headaches.
Administration after expiration date; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9L39Z, expiry date 8th October 2021) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th October 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 12th October 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Other health care professional reported that medical assistant administered a dose of Boostrix vaccine which was expired on 8th October 2021, which led to expired vaccine used. The reporter consented to follow up by mail.
Osteopenia; Osteoporosis; UNDERSIZED PITUITARY GLAND; LESS TESTOSTERONE; COVID-19; Vaccination failure; ALLERGIC TO POISON IVY AND BROKE OUT IN POISON IVY; ALLERGIC TO POISON IVY AND BROKE OUT IN POISON IVY; FUNGAL RASH FROM GENITALS TO UPPER BACK; This spontaneous case was reported by a consumer and describes the occurrence of FUNGAL SKIN INFECTION (FUNGAL RASH FROM GENITALS TO UPPER BACK), EXPOSURE TO TOXIC AGENT (ALLERGIC TO POISON IVY AND BROKE OUT IN POISON IVY), DERMATITIS CONTACT (ALLERGIC TO POISON IVY AND BROKE OUT IN POISON IVY), OSTEOPENIA (Osteopenia) and OSTEOPOROSIS (Osteoporosis) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis and Ulcerative colitis.    Concurrent medical conditions included Allergy to plants (Poison ivy).   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced FUNGAL SKIN INFECTION (FUNGAL RASH FROM GENITALS TO UPPER BACK). In August 2021, the patient experienced EXPOSURE TO TOXIC AGENT (ALLERGIC TO POISON IVY AND BROKE OUT IN POISON IVY) and DERMATITIS CONTACT (ALLERGIC TO POISON IVY AND BROKE OUT IN POISON IVY). On 24-Aug-2021, the patient experienced COVID-19 (COVID-19) and VACCINATION FAILURE (Vaccination failure). On an unknown date, the patient experienced OSTEOPENIA (Osteopenia), OSTEOPOROSIS (Osteoporosis), HYPOPITUITARISM (UNDERSIZED PITUITARY GLAND) and BLOOD TESTOSTERONE DECREASED (LESS TESTOSTERONE). In 2021, FUNGAL SKIN INFECTION (FUNGAL RASH FROM GENITALS TO UPPER BACK) had resolved. At the time of the report, EXPOSURE TO TOXIC AGENT (ALLERGIC TO POISON IVY AND BROKE OUT IN POISON IVY), DERMATITIS CONTACT (ALLERGIC TO POISON IVY AND BROKE OUT IN POISON IVY), OSTEOPENIA (Osteopenia), OSTEOPOROSIS (Osteoporosis), HYPOPITUITARISM (UNDERSIZED PITUITARY GLAND) and BLOOD TESTOSTERONE DECREASED (LESS TESTOSTERONE) had not resolved, COVID-19 (COVID-19) had resolved and VACCINATION FAILURE (Vaccination failure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Aug-2021, Blood testosterone: less testosterone. On 24-Aug-2021, SARS-CoV-2 test: (Positive) Positive.         It was unknown if the patient was enrolled in COVID-19 vaccine trials.  No concomitant product reported by reporter.  COVID-19 was resolved in 2021.  No treatment medication reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
I started with chills and not being able to eat. Chills have left but I still can?t eat. Anything makes my stomach upset...I?ve lost weight already
lymphadenopathy Narrative:  60 yo male with PMH of musculoskeletal chest pain, lbp, radiculopathy, abdominal pain, alcohol dependence, T2DM, HTN, ED, tobacco use and GERD was seen at express care on 3/15/2021 for left arm pit lump x ~ 2 weeks. Pt received covid19 vaccine dose #2 on 3/2/2021. Per express care note, the size of lump changed daily and was tender to palpitation. PER EXPRESS CARE PROGRESS NOTES #Lymphadenopathy s/p COVID vaccines -Left small lump in left axilla, variable in size and temporally consistent with LAD from COVID vaccine, which is well documented in literature -Minimal concern for lymphomatous process at this point--No B symptoms, acute duration. Plan: -Ultrasound of left axilla to rule out abscess -No indication for further work up at this time--if persists for >6 weeks, will consider further blood work
Dizzy to the point he could not compete in gymnastics meet on sat. 1/18. Felt better Sunday 1/19. Tues. 1/21 woke up with an itchy rash on left deltoid area and left upper flank.
Redness and swelling, lump under skin. Parent was advised to give Motrin and apply warm compressed in the right thigh.
Seizure; Breastfeeding after Vaccination; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure) in a 3-month-old infant of an unknown gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    MEDICAL HISTORY (Parent): Concurrent medical conditions included Maternal exposure during breast feeding since 18-Jun-2021.    MEDICAL HISTORY (Patient): Concurrent medical conditions included Seizure since 18-Jun-2021.    On 18-Jun-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 18-Jun-2021,  after exposure to mRNA-1273 (Moderna COVID-19 Vaccine), the infant was diagnosed with SEIZURE (Seizure) (seriousness criteria hospitalization and medically significant) and EXPOSURE VIA BREAST MILK (Breastfeeding after Vaccination). The infant was treated with LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) ongoing since an unknown date for Seizure, at an unspecified dose and frequency. At the time of the report, SEIZURE (Seizure) and EXPOSURE VIA BREAST MILK (Breastfeeding after Vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jun-2021, Specialist consultation: seizure (abnormal) baby was Diagnosed with Seizure by MD.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided.  Reporter reported that the baby started having a seizure 7 hours later the breastfeed. The baby did not have a fever. The baby had a seizure at home and another one at the hospital. The baby was Diagnosed with Seizure by MD.  Company Comment: This is a case of product exposure during breastfeeding with an associated adverse event of seizure in the baby. Based on temporal association a causal relationship cannot be excluded   This case was linked to MOD-2021-231410 (Parent-Child Link).   See case MOD-2021-231410 for details regarding the Parent case.; Sender's Comments: This is a case of product exposure during breastfeeding with an associated adverse event of seizure in the baby. Based on temporal association a causal relationship cannot be excluded
Throat closing, chest tight, wheezing, bloodshot eyes, ears itching, nose dripping, congested nose, slight fever.
Approximately 5 minutes post vax, the pt fell to the ground and proceeded to shake violently. Pupils were dilated. Child regained consciousness within 30 seconds and appeared to be alright. The pt was then taken to the ER.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 05Apr2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 22Aug2020 as dose 1, single (Batch/Lot number: unknown), in right arm, on 05Sep2020 as dose 2, single (Batch/Lot number: unknown), in right arm and on 05Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right 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". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Drug ineffective depends on many factors, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse received from Pfizer sponsored program Pfizer First Connect.  This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the 5th of 20 reports.  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient have tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. Outcome of the event was unknown.    Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, the lack of efficacy cannot be excluded for vaccine BNT162B2.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient
The other three shots (COVID Shots) that I had with it the first two and then the first booster(COVID Shots), I did have side effects that you know they are uncomfortable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Blood pressure high; "Diabetes" (unspecified if ongoing), notes: Diabetes; "everything is you know like arthritis related I had multiple spinal surgery" (unspecified if ongoing), notes: everything is you know like arthritis related I had multiple spinal surgery; "everything is you know like arthritis related I had multiple spinal surgery" (unspecified if ongoing), notes: everything is you know like arthritis related I had multiple spinal surgery. Concomitant medication(s) included: ATORVASTATIN taken for blood pressure measurement; METFORMIN taken for diabetes mellitus; METOPROLOL SUCCINATE taken for blood pressure measurement. The following information was reported: DISCOMFORT (non-serious), outcome "recovered", described as "The other three shots (COVID Shots) that I had with it the first two and then the first booster(COVID Shots), I did have side effects that you know they are uncomfortable". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported by the patient that, the other three shots (COVID Shots) that she had with it the first two and then the first booster (COVID Shots), she did have side effects that they were uncomfortable but only lasted like may be a day and half.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300056755 Same product, patient, different AEs, different dose;US-PFIZER INC-202300058251 Same product, patient, different AEs, different dose;US-PFIZER INC-202300058250 Same product, patient, different AEs, different dose;
This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) and MYALGIA (body ache) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. No Medical History information was reported. On 05-May-2021, the patient received second 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) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced NAUSEA (nausea) and MYALGIA (body ache). At the time of the report, NAUSEA (nausea) and MYALGIA (body ache) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was Not applicable. No concomitant medication wee reported. No treatment medication were provided.
Three days after receiving my second dose, I started to notice I wasn't feeling right. I was experiencing nose bleeds and had flu like symptoms. I got up from bed, it was 1 AM, and I started feeling very dizzy. My walls looked like they were moving and I definitely knew something was off. I checked my blood pressure at home and it was showing 205/110. I checked it three times and received the same result (general range). I went to the hospital ER, where they checked my blood pressure and confirmed that my blood pressure was elevated. I was given clonidine 1/10 mg every 6 hours as needed. My cardiologist gave me Bystolic (Beta Blocker). I took both medications for about three months before my blood pressure returned to normal range. I was taken off clonidine and Bystolic, but continued with olmesartan medoxomil.
Pt states she woke up this morning with shortness of breath, dizziness, nausea and vomiting x 2.  She had no symptoms until this morning.
HCP stated a patient received a regular booster (0.5 mL) instead of the Moderna COVID-19 Vaccine Bivalent on 22Dec2022.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP stated a patient received a regular booster (0.5 mL) instead of the Moderna COVID-19 Vaccine Bivalent on 22Dec2022.) and NO ADVERSE EVENT (No adverse event) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057A22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 2), PFIZER BIONTECH COVID-19 VACCINE (Dose 1) and flu shot. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and flu shot.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (HCP stated a patient received a regular booster (0.5 mL) instead of the Moderna COVID-19 Vaccine Bivalent on 22Dec2022.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP stated a patient received a regular booster (0.5 mL) instead of the Moderna COVID-19 Vaccine Bivalent on 22Dec2022.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (HCP stated a patient received a regular booster (0.5 mL) instead of the Moderna COVID-19 Vaccine Bivalent on 22Dec2022.).    Patient had no known conditions. Concomitant product use was not provided by the reporter.   Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. HCP stated a patient received a regular booster (0.5 mL) instead of the Moderna COVID-19 Vaccine Bivalent on 22 Dec 2022. Previous primary series were from Pfizer, but caller did know the dates of administration. No treatment information was provided.
Information has been received from a registered nurse referring to 3 patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 20-OCT-2015, the patients were vaccinated with ZOSTAVAX (0.65 ml, Lot # L024997, expiration date: 06-OCT-2016), which were improperly stored for 36 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Fever 104.  Crying and irritability.  2x2 inch induration at site of injection for 8 days.  Pain, heat, and bright erythema at site of injection x 8 days.  Diarrhea for 7 days.
Immediately after DTAP & IPV were administered to the left thigh, patient developed hives around the vaccine site (left thigh) and hives on the face.
Symptoms started the night of receiving the 2nd dose of the covid 19 moderna vaccine. Welt like rash directly opposite injection site, rash is hot to the touch/itchy/swollen, entire left arm is stiff/sore, left hand/mainly left hand thumb is experiencing shooting sharp pain that radiates through palm/wrist when moved and is getting increasingly more painful/stiff.
Vaccine was adminsted 5 days after the BUD--contacted Moderna and the lot was still viable. Reporting the error.