chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore right injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore right injection site arm) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 039B21A and 031B21A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore right injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore right injection site arm) outcome was unknown.            Patient weight was 268 lbs.  No medical history was provided by the reporter. No treatment medication were reported.   This case was linked to MOD-2021-416195 (Patient Link).
12/27/21 presents to EC ED for "urinary retention and abdominal pain". PMHx of "recent PID DX (currently on day 8 of 10 of doxy/flagyl), POD4 from abortion c/b retained products requiring a D&C".
Narrative: Pt is a 75y.o. male who died on 04/16/2021 w/ h/o COPD, dementia, and HTN. Pt received Moderna Covid-19 vaccination 2/2 on 02/16/2021. Pt presented to ED on 4/15/2021 for Hemoptysis, kidney stone, Respiratory failure. Pt admitted with finding of hepatic metastases. Pt's family decided to take him off of the ventilator. Pt died inpatient on 04/16/2021. Unlikely that Moderna Covid-19 Vaccine caused/contributed to pt death.
Patient returned 30 minutes after vaccine administration with mild swollen red area radiating in a 3 inch area around the injection site. Patient did not present any other symtoms. The redness around the injection site resolved over the next 30 minutes after Diphenhydramine cream was applied and after multiple applications was almost completely resolved at 4.40pm after telephone conversation with mother of patient.
hives all over body; black and blue bruises; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208), via an unspecified route of administration in the right arm on 15Mar2021 at 12:00(at the age of 48-year-old), as a single dose for COVID-19 immunisation. Medical history included asthma and high blood pressure. Concomitant medications were not reported. The patient did not have any known allergies. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Mar2021 at 10:00, the patient broke out in hives all over the body and the patient went to the urgent care and was prescribed hydroxyzine Hcl 25 mg and prednisone 20 mg and had black and blue bruises on the right arm as therapeutic measures for the adverse events. On 19Mar2021, the patient underwent nasal swab and the result was negative. The clinical outcome of the events hives all over body and black and blue bruises was recovered on an unknown date. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737), via an unspecified route of administration in the right arm on 05Apr2021, as a single dose for COVID-19 immunisation.    No follow-up attempts are needed. No further information is expected.
Recvd imun on 13NOV91 on the 16th devel a t104 Sat-Thurs;
Vomiting; Not feeling well; nausea; Confusion; Potential cognitive issues and having trouble finding words; Potential cognitive issues and having trouble finding words; This is a spontaneous report. A contactable consumer (patient's daughter) reported that a female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunization. The patient's medical history, concomitant medications and investigation assessment were not reported. It was reported that on 22Jan2021, patient was vomiting and not feeling well. Reporter wanted to see if this was a side effect or something different. It was more than just vomiting. The patient was vomiting and not feeling well, but was also having confusion and potential cognitive issues in Jan2021. Patient was having trouble finding her words in Jan2021. Reporter was trying to figure out how emergent the symptoms were and if it was related to the vaccine and also wanted to know if the nausea in Jan2021 was a side effect. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
patient came in to receive Moderna bivalent booster dose of 0.50 ml: the patient actually received 0.25 ml dise
Pvax injected (L) buttock/thigh. Few hours later, pain extending from injection site to knee, muscle felt affected. Next day, pain, ache generalized, temp 100.4 F. Hard to stand on leg (not warm); nausea.
Swelling (Edema, edema)(Edema) - recovered/resolved Redness (rash, rash)(Rash) - recovered/resolved Warmth (Vasodilatation, vasodilatation)(Vasodilat) - recovered/resolved Pain (Pain, pain)(Pain) - recovered/resolved A report was received from an office manager on 11 November 2003 concerning a female vaccinee in the 30's who experienced swelling, redness, warmth and pain on the same day as receiving Fluvirin on 10 November 2003. On 10 November 2003 the vaccinee experienced swelling, redness, warmth and pain. The pain had been becoming milder at the time of the report. The vaccinee had not recovered at the time of the report.  Update 1, 25 November 2003: Further information was received from an office manager on 25 November 2003 indicating that the swelling, redness, warmth and pain experienced by the 46 year old female vaccinee resolved 3 days after onset, on 13 November 2003. There was insufficient information to determine the reporter's causality assessment. No follow up pending.
Symptoms:  strong muscle and joint aches, sporadic headache, short time of ringing in ears, and some nausea. Due to symprtoms, I could not work at my office job for an entire day (1/7/10). Treatment:  aspirin & ibuprofen, sleep. Time course:  1/7 was worst date for symptoms.  I felt 100% recovered by 1/8/10 at 3:00 PM.
Varicella vaccination - 1/2/2013. Onset rash - 1/9/2013. ER for clinical diagnosis 1/12/2013 - vesicular rash.
?sz-t103.2 in MD ofc; passed out; denies any sz activity; pt was brought in to MD ofc p/eating lunch; mom stated that pt wa unresponsive; pt had t103.2 @ MD's ofce 22MAR95;
A report was received from a healthcare professional on 22Nov02 concerning a group of vaccinees less than 4 year old of unk demography who inadvertently received Fluvirin from approx 07Nov02 onwards. From 07Nov02 Fluvirin was administered to vaccinees less than 4 years old. There were no reported adverse events. There was insufficient information to determine the reporter's causality assessment. Update 1 10Dec02: A follow up report was received from a health professional indicating that a 3 year old female vaccinee was inadvertently administered Fluvirin IM on 12Nov02. The vaccinee experienced no adverse reaction. Cross reference: PJP200200848, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857, PJP200200858, PJP200200859, PJP200200860, PJP200200861, PJP200200862, PJP200200805, PJP200200864, PJP200200866, PJP200200867, PJP200200868, PJP200200869, PJP200200870, PJP200200871, PJP200200872, PJP200200873, PJP200200805, PJP200200875, PJP200200876, PJP200200877.
Redness at injection site, tired. Resolved day 4. Then day arm pit pain continued to get more painful. Bump at injection re red and hot.
02/04/2004: Normal crying started after shots.  15 minutes later non-stop crying started pt and mom stayed for 30 minutes, feed bottle and crying continued.  Pt clammed same and then pt mom left.  Telephone call from mom 2 hours later still screaming crying.  Temperature 100, will give Tylenol. Follow up telephone call 02/05/04, mom reported crying for 5 hours total and doing fine today.
This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 04-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at -6.66 Celsius Degrees for 72 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality was involved. This is one of several cases from the same reporter. Additional information has been requested.
Area very red, warm to touch and raised.  Dermatologic patterns: Consistent with urticaria (large local reaction measuring 3cm diameters on anterior right thigh where vaccines were administered.  Per doctor certainly from vaccine.  Subcutaneous involvement only.  Plan to treat symptomatically.
Jynneos administered intramuscularly; Case reference number US-BN-2022-001700 is a spontaneous case report initially received on 27-Jul-2022 from a health care professional via agency (reference number: USBAV22-0690) and concerns a *45-years-old (as reported) male patient*.  The patient's medical history and concomitant medication details were not reported.  On *13-Jul-2022*, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: FDP00002), intramuscularly (IM), at a dose of 0.5 mL, at the *left deltoid* for pre-exposure prophylaxis (PrEP) (explicitly coded as Inappropriate route of vaccination'). As reported, the patient worked in a lab that handled monkeypox samples.   At the time of this report, it was known that the patient did not experience any adverse events due to the Jynneos vaccination.  This case is linked with case no. US-BN-2022-001673, US-BN-2022-001687, US-BN-2022-001688, US-BN-2022-001689, US-BN-2022-001690, US-BN-2022-001691, US-BN-2022-001692, US-BN-2022-001693, US-BN-2022-001694, US-BN-2022-001695, US-BN-2022-001696, US-BN-2022-001697, US-BN-2022-001698, US-BN-2022-001699, US-BN-2022-001701, concerning the same reporter.All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow-up information received from a healthcare professional via Bavarian Nordic on 09-Aug-2022 included patient details and additional information about the administrated dose of Jynneos.; Reporter's Comments: A 45-year-old male patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, at the left deltoid, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 45-year-old male patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, at the left deltoid, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Neuropathy in legs feet toes ankles and hands. Burning stinging tingling and stabbing pain
Patient arrived to ED via ambulance a few days after first COVID-19 vaccine (manufacturer unknown). First COVID shot on Friday, has been experiencing myalgias , weakness, fevers and chills Has been drinking water to try and stay hydrated She has been laying around because she has not been feeling well She tried to get up to answer phone, had dizzy spell and fell forward and hit her right side of head on table.  No LOC Now head, neck, low back pain Patient ambulated on her own
Information has been received from a nurse concerning a 5 year old female who on 16-Feb-2004, was vaccinated with the first dose of OKA/MERCK subcutaneously, and on 25-Apr-2007 was vaccinated with the second dose of OKA/MERCK subcutaneously. Concomitant therapy included the second dose of MSD, the fifth dose of DAPTACEL (C2569AA), and the fourth dose of MRC-5 POLIOVAX (lot# 20872). The patient's symptoms began over the weekend of 06-Sep-2008-07-Sep-2008. On 08-Sep-2008, the patient had 10-15 vesicular lesions on the trunk and neck. The patient developed varicella. CALAMINE lotion was prescribed for symptoms of itching. The patient was recovered from varicella. Follow up information was received which reported that the patient was vaccinated with  PROQUAD, lot# 656163/1354F, on 25-APR-2007, not varicella virus vaccine live OKA/MERCK, VARIVAX AND MMR. No further information is available.
Post vax the patient complained of myalgias, diffuse paresthesis in the lower extremeties, a headache, nausea, weakness in her legs and difficulty ambulating. Lab work was OK. The patient had a marked muscle spasm.
Patient came into the pharmacy on Wednesday (2 days after vaccine). Patient has a rash that has grown over the past 2 days. The rash has fever in it and the patient also experienced a headache and chills. The patient has a swollen lymph node under the arm . We advised patient to see doctor if rash gets worse. As of right now, patient hasn't seen the doctor but the doctor is aware.
3/25/2023 This started with Coughing and slight fever with fatigue, cold sweats, joints pain, sinus pain, and headache.   3/28 went to Urgent Care, tested positive with PCR COVID-19 Test.  Doctor Proscribed Lageviro  and Benzonatate and to treat symptomatically.  Coughing diminished while on medications.  3/30 symptoms improved very slowly.  Symptoms still persist at time of report.
On day of Wednesday day of Moderna vaccine shot, felt good all day, got ready for bed at 9 PM.  Felt very warm and took my temperature it was 99.7.  Not too bad.  My hands and feet were very cold.  Put socks on my feet and climbed in bed.  Feeling ok.  Woke up around 4 AM my tee shirt is soaking wet, had to pee.  Got out of bed and walked to bathroom no problem.  Sat down and then my wife said she heard a loud noise in bathroom.  She comes to check on me and I?m sitting on toilet passed out, I?m leaning to my right against the shower door.  She?s hollering and talks to me to wake up and shakes me and eventually I wake up, get up and walk to the bed no problem.  Then I feel the urge to vomit.  Go through a series of dry heaves, lay on my back and feel urge to vomit again.  Wife tells me to lay on my side, not on my back, that works and I fall asleep.  Woke up Thursday at 8 AM, wife is in the kitchen, I make the bed get dressed and feel ok.  Walk out to the kitchen and wife is amazed I?m OK.  She proceeds to tell me about my passing out in the bath room.  I have no recollection that occurred.  Had some tea and toast, drinking water to rehydrate and felt better.  Walked outside, got leaves out of the pool.  Feeling better.  No further reaction, just a little tired the rest of the day.  Had light lunch, soup.  Took a nap at 3 PM woke refreshed and had normal dinner with a glass of wine.   Today Friday had normal breakfast and feel completely normal.  All in all not a bad reaction.
Pt experienced a varicella like rash, subsequent to receiving one dose of varicella virus vaccine live.
Patient had 24 hour period of fever and chills a a 1 week history of redness to the arm. Sx resolved without sequelae
I am a very healthy individual.  No tobacco, no drugs, minimal alcohol.  Eat well.  Workout-vigorous, for decades.  By Feb 23, 2021 I had an appointment with a cardiologist for a stress echocardiogram.  During the preceding weeks and only after the vaccination I had developed chest discomfort that occurred during my workouts.  Lasted a couple of minutes.  Felt like a balloon expanding in my anterior chest.  It started shortly after the initiation of an aerobic workout and went away, as I say, in a couple of minutes.  I was able to finish a 45 minute workout.   Anyway, it turns out I was throwing PVCs. during the stress echo.   And while throwing them I experienced the chest sensation that I had been concerned about.  Unfortunately, while on the treadmill the sensation was extremely brief...not lasting as long as before.
1/27 After receiving the second dose of Moderna she developed a systemic skin rash. It was all over her body, but was the worst around her wrists/hands. It was very itchy. He skin appeared to have a raised rash and her face flushed. Her airway remained open, her respirations remained even and unlabored. She made no complaint of difficulty breathing. She was given 50mg of Benadryl and she had to sit with the nurse for another hour prior to leaving  Covid clinic sight. 1/28 the rash has almost completely resolved, some blotchy/rash spots left today, but "nothing like it was yesterday"
Information has been received from a nurse practitioner via a company representative referring to a 12 years old female patient. The patient's medical history, concurrent condition and concomitant medication were unknown. On 26-MAR-2015, the patient was vaccinated with the first dose of HPV vaccine (it was unknown whether the patient received GARDASIL or GARDASIL 9) (lot number, strength, dose and route unknown). On 18-AUG-2016, the patient was vaccinated with the second dose of GARDASIL 9 0.5 ml, (lot # L024993, expiration date: 17-OCT-2017) intramuscularly in the right deltoid (Inappropriate schedule of vaccine administered). On approximately 03-SEP-2016 (reported as "2 or 3 days ago"), the patient developed tingling and numbness. On an unspecified date in 2016, the patient also felt paralysis in her hands. The patient had scheduled a follow up visit with the Nurse Practitioner on 06-SEP-2016 for a "neurological" evaluation. The outcome of felt paralysis in her hands, tingling and numbness was unknown. The causal relationship between the events and GARDASIL 9 was unknown. Additional information has been requested.
Pt passed out immediately receiving the vaccine (#3/3) v/s were obtained, pt passed out for approx. 30 sec., she was administered 2L of 02 via nasal cannula and monitored. After she was able, she sat up for 20 min, ate crackers, drank 2 juice boxes. Pt left w/mother - walked out on her own. Total amt. of time approx 30 min.
After receiving my first shot on 1/24/21 I had a sore are and felt tired. After receiving my second Moderna shot on 2/21/21 I had severe chills and felt awful for the next 48 hours. I had a very sore shoulder as well. I have been on Warfarin for almost 20 years due to having Factor V Leiden with a history of DVT in my left leg and a PE in my lungs. I have been on a stable regimen of Warfarin for almost two decades and after the second Moderna shot my protimes have been running very high. I have had numerous conversations with multiple providers and my medicine has been adjusted and my daily dose has been lowered four times now and my INR is still running high. As of this morning I checked my INR on my home monitor and it was a 4.1, which is well outside of the normal range even though the dose of my Warfarin has been lowered multiple times. I am very concerned about what is going on and I've seen my hematologist and primary care doctor. I've been working with the Clinic and they have been working with me to try to get my INR in a stable range but it has yet to get in one. It has been six months of unstable INR results and now I am reaching out to you for help and guidance. Please let me know how you can assist.
Pfizer-BioNTech COVID-19 Vaccine EUA Tenderness at injection site came first then as the evening progress my muscles and joint became very achy and tight. I proceeded to get a sinus headache, runny nose, and nausea/loss of appetite.
a 17 years old patient received a dose of Flublok vaccine/ No AE; Initial information received on 14-Dec-2021 regarding an unsolicited valid non-serious case from a pharmacist via Medical Information (MI) number: 00898092.  This case involves a 17 years old male patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant medications included a booster dose of Coronavirus disease 2019 (COVID-19) VACCINE in arm for prophylactic vaccination.  On 12-Dec-2021, the patient received a 0.5 ml total dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE Pre-filled syringe, strength: standard, frequency: once, lot number: QFAA2116, expiry date: 30-Jun-2022 via intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency: same day).  It was reported "The pharmacist states that one of the associates received Flublok and he is 17 going to be 18 and she would like to know if there are any studies for using Flublok in a person younger than 18 years of age."  Product used: Used, Still using product: No and Was Device Used: Yes.  At the time of reporting, 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 the 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.
Parent reported: "one week after chicken pox vaccination, child developed fever of 102 degrees, sores in throat. Taken to night time pediatrics. Pt was diagnosed with Coxsackie. Fever broke after 8 day. Child was still ill for 10 days? Parent stated she was told diagnoses was related to chicken pox vaccine reactions.
A report has been received from a Health Professional concerning a subject of unknown gender, who had been receiving FLUMIST quadrivalent, (intranasal), 0.2 Millilitres, Once/Single administration. It was reported that the patient tested positive for Type B Flu. The outcome of the event of tested positive for Type B Flu was unknown. The report was considered to be non-serious.
States received vaccine in left arm on 8/17/00. Has had much soreness and pain in right arm since that time. Pain continues in left shoulder and approx. 2 fingers widths below shoulder. Had noticed swelling in deltoid area at about 8-15 days. No discoloration noted at any time. Has difficulty lifting objects, soreness when she raises arm or brings arm in front of her. Does not remember which arm she received varicella in. On 8/17/00, she also received an MMR in the right arm and had stinging sensation but no soreness as in the left arm. Denies injuring the left arm. She states that she had varicella in right arm and also had blood drawn from right arm on 8/18/00.
Death Narrative: Patient with Severe Dementia and on Hospice for end of life care.