chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Big lump, the size of egg that is hot and inflamed/described it as an inflamed area that is travelling down the length of the arm (not in neck)/size is about 2 inches wide and 4 inches long; Big lump, the size of egg that is hot and inflamed/described it as an inflamed area that is travelling down the length of the arm (not in neck)/size is about 2 inches wide and 4 inches long; Big lump, the size of egg that is hot and inflamed/described it as an inflamed area that is travelling down the length of the arm (not in neck)/size is about 2 inches wide and 4 inches long; This is a spontaneous report from a contactable consumer via medical information team. A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 22Feb2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on unknown date for COVID-19 immunisation. It was reported that patient received Pfizer-BioNTech COVID-19 Vaccine second dose last Monday, 22Feb2021, reported to have a big lump, the size of egg that is hot and inflamed. It was said that 72 hours since then it has decreased in size but is still there, described it as an inflamed area that is travelling down the length of the arm (not in neck) looks like someone took a paintbrush. It turns white when touched (redness fades) and it is warm. The size is about 2 inches wide and 4 inches long. The outcome for event was recovering for event big lump, the size of egg that is hot and inflamed while rest all events outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Hurting; He received his Covid-19 Booster Dose; He received his Covid-19 Booster Dose; This is a spontaneous report from a contactable consumer. A 62-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 3 via an unspecified route of administration on an unspecified date (at the age of 62-years-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. Historical vaccine included: first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) as dose 1, single (at the age of 62-years-old) for COVID-19 immunization no adverse event reported. Historical vaccine included: first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) as dose 2, single (at the age of 62-years-old) for COVID-19 immunization no adverse event reported. The patient experienced hurting, patient received COVID-19 booster dose. The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from the patient's husband refers to her wife an approximately 72 year old female patient. Patient with high blood pressure, depression and sleep at night. Patient with no drug reactions or allergies. On an unknown date in June 2013 the patient was vaccinated with ZOSTAVAX (dose, route, lot number and expiration date not reported). Concomitant therapies included lisinopril (manufacturer unknown), sertraline hydrochloride and AMBIEN. Patient's husband reported that two weeks (in approximately June 2013) after his wife received ZOSTAVAX, she began to experience a burning, itchy sensation, much like a sunburn underneath her breast, scalp, neck, ears and back. Patient's husband reported that his wife when to two dermatologists, one of whom recommended she a rheumatologist. Patient's husband reported that his wife saw a rheumatologist in 09-JAN-2014 who conducted a batter of blood tests. Two weeks later 23-JAN-2014, the rheumatologist diagnosed the patient with Sjogren's Syndrome. Patient was being treated with SALAGEN. Patient's husband also reported that his wife began to experience dry and itchy eyes as a result of the Sjogren's Syndrome. The wife saw an eye doctor who treated this by plugging the patient's tear ducts. The dry eye became worse, and the plugs were removed on 01-APR-2014. Patient's eyes have been better since the removal, but not fully resolved. Patient's husband reported that his wife's issues with her skin, was not resolved. Patient's present status was reported as not recovered. Additional information has been requested.
Patient has an allergy to cats, banana, watermelon, kiwi and stated she was already sneezing and itchy in her throat when she arrived. 30 min after vaccine patient was feeling her throat "swelling on the left side". Patient received 25mg Benadryl PO at 11:58. Vitals BP 122/90, R 16, P 82. Patient was monitored for 30 minutes after Benadryl, swelling had seemed to have "gone down", patient able to leave on her own, with escort by family member.
Swollen arm; A little redness; A little pain; This spontaneous case was reported by an other health care professional and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (A little redness) and PAIN (A little pain) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery (For a valve replacement). Concurrent medical conditions included Shortness of breath.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (A little redness) and PAIN (A little pain). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 29-Jan-2021, PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (A little redness) and PAIN (A little pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided.   This case was linked to MOD-2021-060529 (Patient Link).
After about 15 minutes my face felt tingly. Like a slight numbness to my face. I felt it in my forehead, chin, nose, and cheeks. When I got home I took a Benadryl. After about 3 hours my face felt normal again.
This spontaneous report as received from a pharmacist refers to a 70 year old male patient. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX23 (lot#, expiration date and route not reported) when he was "65 or 66 years old". She reported that the patient was diagnosed and treated for pneumonia when he was 70 years old. The outcome of pneumonia was reproted as recovered/resolved. Causality was not reported. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to a 5 week old patient of unknown gender. The patient's medical history and current conditions were not provided. On 13-MAY-2016, the patient was inadvertently vaccinated with a dose of VAQTA (lot #, expiration date, dose and route were not reported) instead of RECOMBIVAX HB. No adverse experience has been reported. The healthcare worker reports that there was no product confusion between VAQTA and RECOMBIVAX HB, the unspecified nurse who administered the vaccines "just grabbed the wrong product". This is one of two reports received from the same reporter. Additional information has been requested.
Itchy on neck; Rash on neck; Rash on injection site; itchy on injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy on neck), RASH (Rash on neck), INJECTION SITE RASH (Rash on injection site) and INJECTION SITE PRURITUS (itchy on injection site) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced PRURITUS (Itchy on neck), RASH (Rash on neck), INJECTION SITE RASH (Rash on injection site) and INJECTION SITE PRURITUS (itchy on injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (Itchy on neck), RASH (Rash on neck), INJECTION SITE RASH (Rash on injection site) and INJECTION SITE PRURITUS (itchy on injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Approximately 3 hours post vax, pt developed fever to 104 with chills and respiratory distress. His fever decreased with Tylenol and Ibuprofen and distress resolved. The following day he developed emesis x 2 and mild diarrhea and continued low-grade fever.
Up all night; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INSOMNIA (Up all night) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Oct-2022, the patient experienced INSOMNIA (Up all night). At the time of the report, INSOMNIA (Up all night) outcome was unknown.            Patient was taking unspecified concomitant medication. He received the booster dose. He did not take any treatment medications.   Reporter did not allow further contact
Information has been received from a registered nurse concerning a male who on 11-AUG-2008, inadvertently was vaccinated with ZOSTAVAX vaccine (Oka/Merck). 0.65 ml, subcutaneously. The registered nurse reported that the intended vaccination was VARIVAX vaccine (Oka/Merck) (MSD) and as a result of an administration error the patient received ZOSTAVAX vaccine (Oka/Merck). At the time of the report no adverse event was reported. Additional information has been requested.
Rash all over body. Admitted through Emergency Room to hospital. Received pills at hospital. 12/02/09 ED Records for DOS 11/23/09  Pt presented to ED with generalized rash, vaccinated 11/21 09 . Ate eggs on 11/22 DX:egg allergy
1335 at the end of her 15 min wait pt states that her neck is itching.  A few red marks noted on her neck.  Pt states that her sx started about 5' after receiving her vaccine.  Pt escorted to observation area.  Vitals 130/88, O2 98, HR 81.  Pt states that she has known mast cell activation syndrome and sees Doctor.  Pt states that she has had reactions like this, treats with Benadryl dosing per allergist.  Pt. states that she has never used an Epi-pen.  Pt denies throat swelling.  Pt is clearing her throat but states that she is getting over sinus infection and this is the same as she has been.  Pt called answering service for allergist and is awaiting a return call from her allergist.  Pt. states that she prefers to go home and get Benadryl vs. waiting in the clinic longer.  Pt. states that her fiancé is a firefighter and she is comfortable leaving with him, since he drove.  1345 BP 130/88, O2 98%, HR 81, Pt escorted to car and left at 1352
HBP called to report inadvertent administration of VARIVAX after a temperature excursion. Limited patient demographics provided. See AE case #02451226 and #02451228. No additional AE/PQC.   ?    Names of vaccines involved (including lot/exp): VARIV; HBP called to report inadvertent administration of VARIVAX after a temperature excursion. Limited patient demographics provided. See AE case #02451226 and #02451228. No additional AE/PQC.   ?    Names of vaccines involved (including lot/exp): VARIV; This spontaneous report was received from a other reporter referring to a patient of unknown age and gender. The patient's pertinent medical history, drug allergies or reactions, and concomitant medications were unknown by the reporter.  On 14-AUG-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), for prophylaxis (formulation, dose, route of administration, vaccination scheme frequency, and anatomical location were not reported; valid lot number W016747 with and expiration date reported as 23-MAY-2024 but upon internal validation established as 23-APR-2024). The administered dose of the vaccine experienced a temperature excursion of 7.3 degrees Fahrenheit for 30 minutes. It was not mentioned if this information was recorded by a data logger or not. There was no adverse effect reported.
insomnia; She is still sweating in her hands and feet, profusely.; rash on my face; really bad reaction; started sweating profusely, really bad, especially her hands; diarrhea / I've had diarrhea ever since 31Aug2021;it has not quit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (really bad reaction), HYPERHIDROSIS (started sweating profusely, really bad, especially her hands), DIARRHOEA (diarrhea / I've had diarrhea ever since 31Aug2021;it has not quit), INSOMNIA (insomnia) and HYPERHIDROSIS (She is still sweating in her hands and feet, profusely.) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Aug-2021, the patient experienced VACCINATION SITE REACTION (really bad reaction), HYPERHIDROSIS (started sweating profusely, really bad, especially her hands) and DIARRHOEA (diarrhea / I've had diarrhea ever since 31Aug2021;it has not quit). On 01-Sep-2021, the patient experienced RASH (rash on my face). On an unknown date, the patient experienced INSOMNIA (insomnia) and HYPERHIDROSIS (She is still sweating in her hands and feet, profusely.). At the time of the report, VACCINATION SITE REACTION (really bad reaction), HYPERHIDROSIS (started sweating profusely, really bad, especially her hands), INSOMNIA (insomnia), HYPERHIDROSIS (She is still sweating in her hands and feet, profusely.) and RASH (rash on my face) outcome was unknown and DIARRHOEA (diarrhea / I've had diarrhea ever since 31Aug2021;it has not quit) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information was provided.
pt brought to ED via EMS with c/o cold sx  X1wk, increasing SOB, altered mental state; given O2 supplementation; positive COVID test in ED; admitted to hospital with severe emphysema, COVID, hyponatremia; respiratory status worsened requiring 15L O2 NRB; DNR/DNI; given dexamethasone; pt's condition worsened and she passed away in the hospital
p/vax pt exp achiness, swelling on hands, chest, and neck; 2wk later pt exp rash; pt had a lyme titre of .24 and a nl CBC
pain at the injection site; muscle pain; This is a spontaneous report from a contactable consumer. A 77-year-old male patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EN5318), dose 1 via an unspecified route of administration, administered in Arm Left on 30Jan2021 12:00 as dose 1, single for covid-19 immunisation (at the age of 77-year-old). Medical history included ongoing hypertension, ongoing blood cholesterol increased, prostate cancer from 2011 to an unknown date, throat cancer from 2006 to an unknown date. Concomitant medications included finasteride (FINASTERIDE) 5mg daily, lisinopril (LIS-INOPRIL) 20 mg daily, simvastatin (SIMVASTATIN) 40 mg daily, tamsulosin (TAMSULOSIN) 4mg daily taken for an unspecified indication from unspecified date of 2012 and ongoing; alendronate sodium (ALENDRONATE) 70 mg weekly taken for an unspecified indication from Dec2020 and ongoing; paracetamol (TYLENOL) 650mg three times daily taken for an unspecified indication from Aug2020 and ongoing. On an unspecified date of Feb2021 patient experienced muscle pain at night and wants to know how long the muscle pain will last. The muscle pain started 4-5 days later after receiving the vaccine. The consumer said that he is experiencing pain at the injection site after the 1st dose of the vaccine. The 1st dose was on 30Jan2021, and the 2nd dose is scheduled for 05Mar2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Diaphoresis, abdominal cramping, loose stools, syncope x2 Lactic acidosis, descending colitis on CT felt to be ischemic colitis.
pt recv 1 dose varivax 8/23/96 & in 2/98 pt exp breakthrough varicella & covered w/lesions, had fever 103f & dizziness. treated w/atarax after therapy w/benadryl was unresponsive
patient received an expired dose of vaccine, no AE; Initial information received on 10-Sep-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a four-year-old male patient who was vaccinated with 0.5 mL expired dose (third dose number and frequency once) of DIPHTHERIA-25/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE (lot C5511AA and expiry date: 30-Aug-2020) via an intramuscular route in the right thigh for prophylactic vaccination on 31-Aug-2020.  The patient's medical history, past medical treatment, family history and concomitant medication were not provided. At the time of the event, the patient had ongoing Tuberculosis. Patient did not have other vaccines.   It was an actual medication error case due to expired vaccine used (latency same day).   At the time of this report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
administered Moderna Covid 19 Bivalent after 30 day use by date; No Adverse Event; administered Moderna Covid 19 Bivalent after 30 day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date), PRODUCT STORAGE ERROR (administered Moderna Covid 19 Bivalent after 30 day use by date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered Moderna Covid 19 Bivalent after 30 day use by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date), PRODUCT STORAGE ERROR (administered Moderna Covid 19 Bivalent after 30 day use by date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date) and PRODUCT STORAGE ERROR (administered Moderna Covid 19 Bivalent after 30 day use by date).    No concomitant medication was provided by the reporter.  It was reported that HCP had called to inform that 4 or 5 adult patients were accidentally administered Moderna COVID-19 Bivalent after 30 day use by date.  No treatment medication was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 14-Dec-2022: Upon internal review on 20-Jan-2023, significant correction was performed to update the Worldwide unique case identification number.
5 x 5" red, swollen, warm arm within 24 hour of getting DTaP and Varivax in that arm. No fever, itching.
on 2nd (possibly 3rd) day after first shot I noticed a hard lump at the injection site. It was about 3/4 of an inch in diameter and tender to touch. No changes noticed until day 6 when it seemed a bit smaller. Finally gone on 8th day.
Exposure to COVID-19 virus  Nasal congestion  Fever and chills  Nausea
Headache and pressure on top of head 1:30 PM -1:40 PM.   Joint ache in knees 72 hours  through 4/4/2022 slightly sore arm R 48 hours, fatigue 72 hours
My husband got Covid and three days later I had congestion and sore throat and generally feeling bad my first test was negative but on 17FEB2023 I felt worse and my test was positive. I called my doctor I spoke with a nurse and set up a video appointment with a different doctor and I was prescribed PAXLOVID. I was sick or felt bad for a week and felt better then crashed again on a Sunday. The doctor said it was rebound Covid, I tested positive for about two weeks then had a negative test.
Right arm pain, weakness, with mild paresthesias.  Worse at night, within 5 hours of vaccine.  Treated with steroids, Motrin.  Currently starting electro-stimulation and PT.  At this point, some decrease in pain and weakness but not resolved.  Seen by orthopedist, underwent MRI and X-rays.  Diagnosis at this time: Parsonage-Turner Syndrome.
~8 hours after injection: achy, shaky, chills ~hour 9-12 after injection: splitting headache - slept and woke every hour ~hours 25-27 after injection: throbbing headache, lightheaded, overheating, minor vomiting, Increased heart rate
Mom noted red rash at left deltoid 2 days after receiving vaccines. No history of fevers, breathing problems.
Hives and rash breakout all over torso, neck and groin area 9 days after initial vaccination. Itch started in both armpits and then spread to the rest of the body. Prescribed Benadryl, Pepcid (20mg, Zyrtec (10mg) and Prednisone (20mg). Treatment ongoing.
I noticed the pain in my left shoulder and thought it might be associated with carrying a heavy backpack or sleeping wrong. There was no dissipation of the pain, so I went to an orthopedic practitioner at a local health facility for x-rays. They didn't see arthritic signs and I was given a prescription for physical therapy. I have not followed up on that yet. As far as the pain, it feels like soreness and I can't lift my arm over my head. It's painful to reach back and painful to do any extensive movement.
p/ pt recv vax following day exp redness & swelling,  soreness @ inj site, & had 6 mm induration @ inject site