chrisvoncsefalvay/vaers-outcomes huggingface dataset:
aches and pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches and pain) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00LEZ0A) for COVID-19 vaccination.     The patient's past medical history included Ache NOS and Pain. Concomitant products included IBUPROFEN (ADVIL 12 HOUR) for Pain, MOMETASONE FUROATE (NASONEX), VITAMIN B NOS, RISPERIDONE (RISPERDAL) and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN (aches and pain). At the time of the report, PAIN (aches and pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
On set 9-20-2008  0500 - of fever, chills, twitching, full body, vomited x1 (vomiting reported by child) not certain as parent did not witness discussed with on call MD - question flu like viral illness or reaction to TDAP.  Monitor & hydrate call if increasing concerns.
patient had arm swelling at site of injection; fatigue; Twelve Year Old patient received the Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE SWELLING (patient had arm swelling at site of injection), FATIGUE (fatigue) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Twelve Year Old patient received the Moderna Covid-19 vaccine) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 17-Jul-2021.    On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Twelve Year Old patient received the Moderna Covid-19 vaccine). On 28-Aug-2021, the patient experienced VACCINATION SITE SWELLING (patient had arm swelling at site of injection) and FATIGUE (fatigue). On 27-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Twelve Year Old patient received the Moderna Covid-19 vaccine) had resolved. On 29-Aug-2021, FATIGUE (fatigue) had resolved. At the time of the report, VACCINATION SITE SWELLING (patient had arm swelling at site of injection) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive.     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.   No concomitant medications are provided. No treatment  medications to the events were reported. Allergies to medications, food, and other products - NKDA   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Vaccine  information - Updated the start date and patient route of administration updated from the initial case.Significant follow up received on 01-SEP-2021 contains- Updated Patient demographics, Medical history,Added the dose number, Vaccine History and Updated  Events- Patient had arm swelling at site of injection, Fatigue and the non-drug treatment also updated.
Headache onset 8-9 pm 5/11/07. Persisted 5/12, 5/13, 5/14 went to school 5/14/07, but felt awful after school. No fever or vomiting. Headache is in both temples and across top of head. 5/15/07 headache is improved w/use of Ibuprofen alternating w/Tylenol.
My younger brother experienced signs of a stomach bug early in the week before my shot. He is 3 years old. He had trouble sleeping, vomited, but  had no loose stool. My mum experienced the same symptoms while caring for him and recovered in time with him as well. By Friday, my dad got it while my brother and mum had recovered. He quarantined himself and rested in the master bedroom. He reports one loose bowel episode and vomited once. Late that night, past midnight, I had loose stool and vomited. Seeing that I got my shot Thursday, I can't say if it influenced me or not. Post-nausea spells, I vomited a couple times and had bowel movements a couple of times too. My sister reports loose bowel movements last night and there are no other family members at home.  After vomiting that night, I felt better and went to sleep. When I woke up I had full body pains, low appetite, and a light fever. After drinking an electrolyte mix with pure orange juice, I napped, and woke up later feeling a bit better, but with a higher temperature/fever. My body aches remained throughout the day and by the end, my temperature dropped to 97.8F. I slept late and woke up on Sunday past noon. So I didnt eat anything until I made porridge in the evening. Only had water. This could explain the nausea I had the whole evening until I ate. Never managed to vomit. My body aches are gone and my temperature is normal (96.3).
This spontaneous report was received from a Licensed Practical Nurse regarding an unspecified number of patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K009943, and expiration date 03-APR-2016 and lot # L019299, expiration date 15-APR-2017 and lot # L010595. and expiration date 12-DEC-2016 (incorrect product storage). No concomitant medication was reported. No adverse event  was reported. The outcome of the event was unknown. Thi sis one of several reports received from the same reporter. Additional information has been requested.
8/20/05 developed hives on face, shoulders, abdomen and buttocks with orbital edema and pruritus. Pt took 2 Benadryl capsules and had no hives the next day. On 8/23/05 Hives returned on abdomen only. No hives on 8/24/05 pt discontinued minocycline on 8/20/05.
Information has been received from a LPN concerning a 7 year old female with an allergy to Vantin and no pertinent past medical history who on 10/31/97 was vaccinated SC with a 0.5mL dose of varicella virus vaccine live (Lot # 622749/0544E).  There was no concomitant medication. On 09/03/03 the pt developed an undocumented number of lesions on the chest, abdomen, and legs. The pt was treated with topical "Alveeno", oral Benadryl and oral Tylenol. The reporter indicated that the pt is "now" recovered. Unspecified medical attention was sought and treatment was required. A product quality complaint was not involved. Follow up was received from the LPN which indicated that no further information is available. No further information is expected.
5/5/2021 - developed a scratchy/painful throat, markedly enlarged lymph nodes on left side of throat and chills.  5/10/2021 - seen by PCP.  negative monospot, strep.  Elevated CRP and SED rate.  Treated with augmentin 5/12/2021 - seen by ENT.  Improvement of tonsil size post augmentin.  Prescribed Medrol dose pack and CT ordered 5/13/2021 - seen by PCP.  Continued improvement of lymph node size even though Medrol dose pack was not started.  Upcoming CT and return appointment by ENT.
All of the typical side effects.   The one that was different was the violent shaking all over.  I was not cold.  I woke up in the middle of the night violently shaking uncontrollably.
pt recv vax 4AUG95 & on 11JUN97 pt devel breakthrough chickenpox consisting of approx 12 lesions;
I had a delayed red rash appear on my arm  about 11 days after my vaccine. I first became aware of it as the skin on my arm from the location where I received the vaccine down to about 2" above my elbow began to feel tight and itchy and turn red. It isn't really bothersome, just noticeably red and slightly elevated  so I have not and don't intend to call my doctor. I just thought you may want to include this in your database.  I also saw the news that this kind of delayed skin reaction has been reported, is not serious and not a reason to forego receiving the second dose so I am not concerned about safety.  I have taken a photo of it should it be requested.
The vaccine sped up my heart rate significantly. Unfortunately this ?tripped? my heart and resulted in about 8 hours of Afib. I took my go to medicine, Fleccanide and after about 150 mgs of this, the Afib ceased. Also my temperature was raised to about 99 degrees and I felt lethargic. I feel much better now , 40 hours after the vaccine.
Thumb on left hand turned entirely black, skin died. After seeing Infectious Disease and receiving IV antibiotics with no improvement, Dermatology consult was made. After a biopsy, it was diagnosed as Sweet Syndrome. Ongoing steroid treatment, whirlpool treatment of wound.
Hospitalized 2/24/22-2/28/22 Fever with chills, cough, weakness, nausea and diarrhea, body aches, SOB, chest pain, sore throat, headaches, hypoxia, PNA,  respiratory failure, d/c home on O2
Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a patient (age and gender not reported) who was vaccinated with a dose of expired vaccine PENTACEL (lot number not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used. It was not reported whether the patient had any adverse events following the vaccination. 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. Documents held by sender: none.
I had intense muscle soreness in hips and legs and chills/shaking that lasted for 30-40 minutes.  After the episode was over, I was OK
A report has been received from a health professional concerning an 8 year old female subject, who had been receiving nasal FLUMIST. FLUMIST started on 15-JAN-2014. The patient was given expired FLUMIST. The patient experienced expired FLUMIST which started on 15-JAN-2014. The outcome of the event of expired FLUMIST is unknown. The report was considered to be non-serious by the company physician.
Headache, Fever, Chills, Axillary Swelling Narrative:
pt recvd MMR vax on 24SEP83 then pt was revaxed on 4APR90 & 10MAY91 pt was dx w/mumps;
No additional AE; HCP called to report inadvertent administration of an expired dose of MMR II.  No adverse effects reported.  MMR II expired 2/26/2023 and patient was administered the vaccine today, 5/16/2023.  HCP also asked about the need for revaccination.  Post E; This spontaneous report as received from a nurse referring to a 54-year-old patient of unreported gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 16-MAY-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) lot number U006485, expiration date 26-FEB-2023, 0.5 milliliter (route of administration not reported) for prophylaxis (expired product administered). No adverse event was reported.
From initial information received on 05/27/03 from a healthcare professional, regarding an adverse event occurring in the US, it was reported that a 58 year old female pt received a dose of TD ADS ADULT, Lot # U0831AA, given IM in the right arm on 05/23/03.  On 05/26/03, three days later, the pt developed a red, painful, swollen area at the injection site with puss discharge. On an unspecified date, the pt was seen by a physician.  Reportedly, the recovery status is unknown. The reporter of this case is the same reporter for case: 2003-01358.
Received the shot, seemed fine. A couple of days later I noticed a raised red spot where injection was. Symptoms also include, warm and itchy.  A couple of days after that it seemed to be getting worse, it now looks like a bullseye. I have taken Benadryl and have put an ice pack on my arm, this symptom has not gotten any better. I called my doctors office this morning and talked to a man who said he was a nurse working with my doctor and told me to file the information here on VEARS. Please notify me by email or my phone number if there is something else i should be doing, I am concerned about getting the second vaccine, and if there will be other complications with it. Or, if I do not get the second vaccine, I am high-risk, where does this put my for risk of Covid-19.
Information has been received from a physician's office manager concerning 5 patients who were vaccinated with varicella virus vaccine live. Subsequently the patients developed chicken pox lesions. Unspecified medical attention was sought. Additional information has been requested.
Pain in left arm 6 weeks post vaccination. Appears vaccine given too high up on arm causing shoulder injury related to vaccination. Pain slowly improving.
Patient was given an undiluted dose of the Phizer bivalent for age (5-11), 0.2 mLs.
Information has been received through the Merck pregnancy registry from a physician concerning a female with a history of 0 pregnancies and 0 live births and a history of anxiety disorder who on 26-JUL-2007 was vaccinated with the first dose of Gardasil (658490/0802U).  Concomitant therapy included prenatal vitamins.  Subsequently, the patient was determined to be pregnant (last menstrual serious 09-JUL-2007).  On 29-NOV-2007, the patient had an ultrasound which revealed normal anatomy.  Estimated date of delivery was 26-MAR-2008.  It was reported that on an unspecified date the patient was admitted to the hospital for one week due to possible sepsis.  Subsequently, the patient developed chorioamnioitis.  On 25-MAR-2008, the patient developed maternal exhaustion while pushing and had a vacuum assisted vaginal delivery.  She delivered a normal male infant, Apgar score was 2/5 and 8 at 10 minutes.  The baby weight 3200 grams and head circumference was 33 1/4 cm.  Additional information has been requested.
Information was received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unspecified dates, the patients were administered improperly stored VARIVAX injection (lot #L034368, expired on 08-SEP-2017) (dose and route unknown). No adverse effect was reported. Additional information has been requested.
Headache, Arthralgia, Fever, Chills Narrative: Headache, body aches, fever 101.2, chills
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (merck) Injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX (merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARIVAX (merck) temperature excursion and two patients of unspecified age and gender who were vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J008652, exp date: 10-JUL-2015 also reported as 03-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
None noted-did not disclose that she was pregnant at the time of screening. Given Flumist then told she was pregnant 2 months.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 as dose 5 (booster), single (Lot number: GH9702), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (03Jun2023) Positive, notes: Had faint positive line for three days after completion of 5-day Paxlovid series; (04Jun2023) Positive, notes: Had faint positive line for three days after completion of 5-day Paxlovid series; (05Jun2023) Positive, notes: Had faint positive line for three days after completion of 5-day Paxlovid series; (06Jun2023) Positive, notes: Positive line on day 4 after completing Paxlovid series. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid).
Side effects continue though today -extreme fatigue - joint pain started with arms and shoulders and neck left those and went to elbows and hands  now is in legs
PATIENT REPORTED ON 10/10/2014 TO PHARMACIST OF PAIN STILL AT INJECTION SITE.  STATED NO SWELLING OR REDNESS AT SITE.  NO FEVER WAS NOTED AS WELL.    RECOMMENDED TO SPEAK TO PHYSICIAN CONCERNING PAIN.
Treatment of COVID-19; Treatment of 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 60-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing); "diabetes" (unspecified if ongoing). 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 "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300303873 same patient, different drug/AE;
right arm injections site pain.  Pain that started on day of injection in right lateral shoulder that radiated into right neck and eventually to left neck causing stiff neck type feeling.  Next day noticed numbness and tingling from right shoulder down arm and into right 5th digit that is still present 1 week later.  Pt is waiting to see if symptoms improve prior to being seen by a provider.
Information has been received from a physician concerning a 14 year old female who was vaccinated with the first dose of GARDASIL (lot# not reported) 0.5ml, injection four or six weeks ago. Concomitant therapy included hepatitis A virus vaccine (unspecified) and Mananjacocus. The patient experienced hives after getting first dose of GARDASIL. On unspecified date, the patient sought unspecified medical attention. Additional information has been requested.
Patient-reported generalized itching after vaccination. There was no obvious skin lesion of note on the body. She reports that she often has issues with itching and takes antihistamines 1-2 times per day on a regular basis, but has not done so yet today. She requested 50mg of oral Benadryl.  She was given 50mg of Benadryl, which she takes on a regular basis without sedation. After monitoring, she had returned to baseline and returned home.
pt had episode of turning pale & limp 10-11PM 13DEC95;pt was also quite listless, very frightened;took pt to MD 15DEC was told OK to get 3rd set of vax if uses APAP;did not give any APAP p/this immun
Information has been received from a health professional concerning a 10 year old male who in 1998 was vaccinated with a dose of varicella virus vaccine live. On 4/2/2005 the patient experienced chickenpox from head to toe.  It was noted that they were even in the conjunctiva. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
I am writing adding this to my comments page since it is sometimes hard to read my writing.  I have two devastating happenings. Each will be separate but you can see how close together they occurred.  In June my ophthalmologist referred me to Glaucoma specialties who examined my left eye. You can read the reports.  I had been on Travatan Z for my Right eye for several years without problem. Dr advised me to put it in both eyes .June 18 2019  Next visit after exam He added Combigan See date on file enclosed.  Next he added Dorzolamide HCL 2%eye drops. After today's I wanted to stay in bed.  I told him I couldn't take them. I still have all pills left for proof of number taken. I had my laser treatment (108 zaps in left eye) on August 29th/19 Tol to tay on Combigan but I noticed in less than a week I began it itch all over. Seemed to progress and in three nights I reported this and they suggested I not take them or 4 days. It seemed to halt further progression, but still became more and more prolific.  I called the doctor and He said He never heard of this and I had a skin decease.   I have gon to the Dermatologist who prescribed Fluocinolone 0.01% (11/4/19) in Cera ve cream. At this time I am slowly healing.  (2) Unfortunate decision to take a Pneumonia shot at pharmacy since I never had one. Wrong decision. I noticed and circled the Formaldehyde listed think it was just a generic listing. Wrong again I have been embalmed prematurely. Before this I never had an ache in my body AS I write I have to go to Dr, general Physician who say my change and said I should not have had any of these medications at my age. Sent to therapist, who said I look like a person 70 years of age. I am 93.5. I am not trying to find ways to detox. I decided to take as hot a shower as I can stand for as long as I can to loosen my shoulders  I can barely get out of bed in AM. all shoulders. hips and knees are stiff. I wish I could sue. But they have our hands tied there as well. Maybe if I'm dead one lawyer will star a class action suit. I am the keeper still working in my personal rentals keeping my sone who is buried] in Health insure obligations since he had a heart attack year ago at 45 and lot his good job.
After receiving COVID Booster in left arm, developed pain and a knot to injection site, reports discomfort with flexing the left arm/shoulder, reports tenderness/pain when pressure is applied to injection site.  Has been applying icing/heat, taking OTC analgesics, Ibuprofen.   Injection site swollen and firm, warm to touch.  left axilla lymphadenopathy