chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flu like symptoms; achy glands under her neck; pain at the injection site; headache; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), LYMPH NODE PAIN (achy glands under her neck), INJECTION SITE PAIN (pain at the injection site) and HEADACHE (headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (esophageal). Concomitant products included OMEPRAZOLE for Acid reflux (esophageal).   On 14-Apr-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 14-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), LYMPH NODE PAIN (achy glands under her neck), INJECTION SITE PAIN (pain at the injection site) and HEADACHE (headache). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), LYMPH NODE PAIN (achy glands under her neck), INJECTION SITE PAIN (pain at the injection site) and HEADACHE (headache) outcome was unknown. Not Provided          No treatment information was provided.    This case was linked to MOD-2021-076578 (E2B Linked Report).; Sender's Comments:  MOD-2021-076578:First dose case
Headaches, diarrhea, itchy around injection it?s, large painful lump under left armpit
I'm a smoker, around 9 PM, I lit a cigarette, took a drag and immediately started coughing. A little while later I started to experience achyness and hot and cold chills, feverish, along with a headache. Around 10:30 PM I became nauseous and threw up violently until my stomach was empty. After I threw up I began to feel a little better and was able to go to sleep. In the morning,  I still felt a little achy but fever and hot and cold chills were gone. It's 8:40 PM now (the next day) and I'm still achy and foggy. I've been taking one 500mg Tylenol every 6 hours or so.
My face is swollen, I also have a sharp pain on the left side of my kidney and almost like is hitting my heart. My breathing is like if I have asthma and my eyes feel like if I have sand in them.
4 or 5 year-old child received Flublok, no Adverse event; Initial information received on 16-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a child patient (age reported as 4 or 5 year-old) who received an INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: unknown, expiry date: unknown) via unknown route and site on an unknown date for prophylactic vaccination (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, concomitant therapy, vaccinations and family history were not provided.  It was an actual medication error due to Inappropriate age at vaccine administration. (latency- on the same day).  At the time of reporting, patient had not experienced any adverse event.  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 and Module VI of the 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.  There will be no information available on the batch number for this case.
Beginning at 10 days post-injection, patient experienced random spells throughout the day of lightheadedness/loss of balance with vision narrowing (ie everything going black), and the feeling that he was about to pass out. These spells would last for 20-30 seconds each time and continued for 2 weeks post-injection. During the last 6 months he has been experiencing ongoing cognitive issues similar to dyslexia while doing mindless tasks such as typing, where he will get the letters in a word correct but not in the right order. He has never experienced cognitive issues like this before, and they are still ongoing.
Left foot and ankle became extremely swollen and burning - looked like a loaf of bread and felt like it was in the toaster. After a month swelling went down enough that I could wiggle my toes. It is now 10 weeks later and still somewhat swollen. July 20, 2018: I had gotten the original several years ago (back when insurance was not paying for it) and I asked my doctor if he thought I should get this new one and he gave me the OK. I got the shot at noon and by 8:00 that night, I was wishing that I hadn't. My left foot became extremely swollen and burning. As I described it...it looked like a loaf of bread and felt like it was stuck in the toaster. It was 2 weeks before I could get an appointment with the doctor. He ordered x ray and a test for possible blood clot. Both tests came back with no evidence of cause. It was a month before the swelling came down enough that I could wiggle my toes. The burning has pretty much stopped, and I think that the discomfort I experience now is caused by the tightness in the top of the foot and ankle, and the fact that the ankle doesn't flex as it should. I have missed 10 weeks of exercise classes and I feel the loss of strength...relying sometimes now on the use of a cane for assistance. I am hoping to get back to class and do just what I can. I would like to learn the cause of this reaction and possible favorable treatment. There was never any rash or redness. If, through your studies, you find any explanation or treatment, I would appreciate hearing from you. Possible some shingles, no rash. I'm assuming that I should not get the follow-up 2nd shot?
Breakthrough case after 2 vaccines moderna 4/6/21 Lot# 047A21A;  Moderna 5/4/21 Lot# 025B21A
Patient was vaccinated with Moderna Bivalent 6mo-5yo at a dosage of 0.25 ml after a verbal order from Dr. due to the interim time of the new FDA guidelines and no standing orders.  It was later realized that the new guidelines changed the recommendations from the Moderna Bivalent 6mo-5yo formulation to the Moderna Bivalent 6 years and older formulation  for the  age group of 6mo-5yo with the dosage of 0.25 ml.  After speaking with Dr, who consulted with another, it was decided that the patient could be offered the remaining 0.12 ml in order for the patient to receive the full antigen amount.  The patients were contacted and offered the remaining amount and stated they would discuss it and call back to schedule if they decided to proceed.
Pt. at 9:05 am at observation line was having weakness of the body, dizziness and felt a heat flash over her body.  Paramedics assessed pt. once symptoms subsided the paramedics let pt. leave tent 1.
rash got slightly worse; chills; extremely tired; achy body; wanted to sleep all day; rash over injection site; achy arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy arm), CHILLS (chills), FATIGUE (extremely tired), MYALGIA (achy body) and SOMNOLENCE (wanted to sleep all day) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 012A21A) 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 medical history reported.).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced PAIN (achy arm). On 06-Apr-2021, the patient experienced CHILLS (chills), FATIGUE (extremely tired), MYALGIA (achy body), SOMNOLENCE (wanted to sleep all day) and INJECTION SITE RASH (rash over injection site). On 07-Apr-2021, the patient experienced RASH (rash got slightly worse). On 07-Apr-2021, MYALGIA (achy body) had resolved. At the time of the report, PAIN (achy arm), CHILLS (chills), FATIGUE (extremely tired), SOMNOLENCE (wanted to sleep all day), INJECTION SITE RASH (rash over injection site) and RASH (rash got slightly worse) had resolved.            Action taken with mRNA-1273 in response to the events was not Applicable.  No concomitant medications were provided.  No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-073365 (E2B Linked Report). This case was linked to MOD-2021-073365 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: follow-up received and Patient said all her events are resolved, did not provide email ID, declined further follow up declined further follow up.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073365:2nd dose case
The patient's second dose of their COVID (Moderna) shot was received over 42 days after the patient's first dose. The first dose was received on April 20, 2021 and the second dose was received on January 10, 2022.
Information has been received from a registered nurse (R.N.) concerning a female child in elementary school (who is between grades 3-5) who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). It was reported that an outbreak of chickenpox began in an elementary school in November 2005. "Recently", "since November 2005", the female child developed chickenpox and sought unspecified medical attention. No outcome was reported. No outcome was reported. No product quality complaint was involved.
Less than an hour after I received the shot, I started feeling nauseous, dizzy, lightheaded, confused/brain fog (I literally felt drunk), hot and cold flashes and generally unwell. The next day, I woke up with a sore throat and a head cold. The brain fog, bad nausea, internal temp issues and general unwell feeling lasted through Saturday. The SCARIEST part was that it felt like my heart hurt when I was breathing on the third day. I currently have a shoulder injury, so I took ibuprofen and the heart pain went away.
I became very stuffy, when my granddaughter tested positive, I tested myself at home COVID-19, it was positive. Next day I called the doctor assistant, my symptoms were mild, I had runny nose for 3 days. I was a little tired. I just took TYLENOL. I tested negative on the 12th day.
About 2 weeks after I received my 3rd dose, I started having breathing problems. I was blaming it on the cedar pollen. I can normally manage it with anti histamines, but this time it was a bit more difficult to breath. I was getting more winded than normal while lifting weights and I couldn't catch my breath. I ended up having to get an albuterol inhaler and a steroid. I had a lot of wheezing and coughing and I hadn't experienced this before. I think the problem was due to my immune system and having lime disease in the past.
1wk p/vax both palms of hands got red & started to peel;entire top layer of skin peeled off;no fever or other sx;in 2wk was back to nl;
Pain left axilla developed evening of vaccine given date, next day developed pain over left side chest with fluctuating heart rate.  Per patient he went to ERD on 3/15 where he had a chest xray and ekg with normal results, advised to take pain meds and follow up with PCP.  On 3/16/21 pt seen via call advised to take anti inflamatories and labs ordered.  Follow up OV on 3/22/21 CT chest ordered, prescribed pain med and anti inflammatories. 3/29 follow up visit- symptoms unresolved, 4/5 sympt unresolved, 4/15 4wks post injection sympt continue order Ultra sound left extremity
Covid 19 Pfizer Gray Top was diluted with 1.8 ml of diluent. Patient received diluted dose
Within 6 minutes of infection had lightheadedness & difficulty breathing.  This was followed by red flushing to the skin on the face and left neck, shoulder & hip pain.  BP initially was 182/98 which is elevated for me.  Felt disoriented & very unwell.  Over the next few days, low BP was noted @90/62, pulse 58.  This occurred intermittently.
pt recv vax; 5 mins later, exp raised plaque w/ 2 urticarial lesions at inject site;was described as a wheal/flare;exp sl redness at inject site & enlarged vesiculation for about 25 mins;urticaria resolved & only redness remained;
LEFT ARM NUMBNESS; SHOCKING PAIN IN LEFT ARM; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-APR-2021, the subject experienced left arm numbness. On 10-APR-2021, the subject experienced shocking pain in left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left arm numbness, and shocking pain in left arm. This report was non-serious.
As a military veteran, I have had a low level form of tinitus since serving during Vietnam era.    Since receiving Moderna second injection, following 1-2 weeks, my tinitus has significantly increased from a level 2 to a level 7-8 and has remained at that level to date  ( approx 5 months).  I have completed a TON of research on line, and have discovered that there are many websites operated by audiology physicians that are reporting  possibly thousands of patients are discovering a link between exasperated tinitus or NEW tinitus findings.  Ironically however; the CDC or media is not reporting ANY SUCH adverse reaction, as I am suspecting out of fear that vaccine levels will plummet.  Im not sure many people are taking the time to report this, but I am, and I am telling everyone I know of this side affect that occurred to me.  I got vaccinated not for myself, but for a 95 y/o that lives in my household.  She is frail yet healthy.    I REGRET getting the vaccine, and would have elected to remain A SHUT IN, rather than listen to a train in my head for the rest of my life.  This SUCKS !
Patient decided not to receive her second dose of Moderna Covid vaccine due to ongoing  adverse effects from  receiving the first dose. Patient states experiencing severe arm pain, and persistent unresolved shortness of breath and difficulty breathing  even four weeks past the first dose. Her physician believes the side effects will resolve on their own, reporting due to the ongoing breathing  issues.
1st day (10:30 am):- left arm sore/painful,  overnight : freezing, burning sensation and extreme fatigue. 2nd  day(01/15/21):- left arm  still sore not painful but fatigue continued 3rd day(1/16/21):-  10:30 am, Temple left vein  burst at the fore head from middle to left eye, covered with red dots bleeding from left temple eye until 6:00 pm  throbbing pain all day and night.  4th day (01/17/21):- Swollen left side of face, internal bleeding around the left eye, slight throbbing pain, extreme fatigue.  5th day (01/08/21):- Swelling/bruises and internal bleeding visible. Less fatigue, able to go to pharmacy to report. *Report as presented by the Patient.
injection site soreness; night sweats; itchy, hive-like rash on both arms 48 hours after shot; very mild pain during urination for a couple weeks; moderate arm pain the day after injection; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: ER8734), via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 14:15 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies. Concomitant medications included flax seed oil (MANUFACTURER UNKNWON) and multi vitamin (MANUFACTURER UNKNOWN) for unknown indication from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient experienced injection site soreness and moderate arm pain the day after injection at 00:00, night sweats from second night and continued for 7 days, itchy hive-like rash on both arms 48 hours after shot (lasted for 2-3 days), no medical attention needed and urination pain for a couple weeks, all on an unknown date in Apr2021. The clinical outcome of vaccination site pain, itchy rash, night sweats, pain in arm and urination pain was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced VOMITING (vomiting). At the time of the report, VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment medications was reported.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 04-OCT-2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the long term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 13-MAY-2014, the patient was treated at a medical center for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Had seizure activity hrs after receiving MMR/PCV and flu vaccination. The patient had slight fever 99 degrees F and diagnosed with DM and amoxicillin was prescribed child was taken to ED, given ibuprofen and discharged.
pt recvd vax for prophylaxis;immed p/ dose 2 exp hives;tx w/ dph & subsided in 5 days;
Initial report received on 16 August 2007 from a health care professional. A 34 year old male patient received on 06 August 2007 a dose of Decavac (lot# U1944DA), intramuscular into the left deltoid. On 07 August 2007, one day later, he experienced left shoulder severe pain and inflammation in joint. The patient received "prednisone shots". Relevant diagnostic tests was not available. The patient did not receive any other concomitant vaccination. Concomitant medications included Advil, as needed (PRN). The patient's ongoing illness included a laceration of middle finger. The patient did not have any adverse event following prior vaccination. The patient had not recovered. Follow-up information received on 15 January 2008 from a health care professional. The route and site of administration were reported as intramuscular and shoulder. Per the reporter, the vaccine was administered high, possibly into the shoulder bursa. The patient now has rotator cuff involvement and pain. At the time of this report, the patient had not recovered. Follow-up information was received from the health professional on 17 January 2008. based upon this new information, it was determined that the event meets the seriousness criteria for "Other - medically significant". In light of this new information, the case has been upgraded to serious. The patient received Decavac in the left shoulder, and immediately developed pain and discomfort at the injection site, along with an area of induration approximately the size of a "50-cent piece". An MRI revealed an edematous rotator cuff. Since the, he had been treated with several courses of prednisone, local injections of kenalog into the bursa and muscle tendon, and oral decadron. He also underwent physical therapy. Per the reporter, the patient had experienced increased range of motion and decreased pain after initiating therapy with decadron.
The patient is suffering from  SIRVA (Shoulder Injury Related  to Vaccine Administration).  She can not move her arm and she tried using the compress as she was told by her physician and showed the injection site to a medical professional for advise, where she was told it was related to administration of vaccine.
12 hours after vaccine injection, experienced a 103.2 degree fever, sweating (lost 3 lbs in one day) and extreme body aches (unable to sleep due to pain)  24 - 36 hrs after vaccine injection  experienced extreme chills & body aches. 96 hrs after vaccine injection, still had a 100.6 degree fever and migraine like headache and developed a rash all over my body that lasted for 48 hours and was only subdued by taking Benedryl.
After being injected with vaccine, area around injection site started to itch, the spread to arm, shoulder, neck, chest, & back. Within 1 hour of injection.
Initial report received from a physician on 23 October 2014. A 3-year-old female patient, with no reported medical history, received a dose of FLUZONE, (lot number not reported) "last year", i.e. 2013. Within one hour of vaccination, she experienced a significant allergic reaction, consisting of angioedema. The patient was seen by a physician, and the event subsequently recovered on an unspecified date. The reporter was concerned that the patient might have an issue with gelatin. No additional information was reported. Documents held by sender: None. Follow-up information received on 17-NOV-2014 by a health care professional. The patient had received Flu vaccine in the past. She had an allergic reaction following administration of MMRV, Dtap and IPV vaccine. Her Allergy skin prick test was positive to MMRV vaccine, gelatin or NEOMYCIN.
Chills, fever, flushing, injection site pain, nausea, all over body/muscle aches, sleeplessness, severe headache, lasting 48 hours.
Fatigue - onset approximately 2 hours post-injection, x 2 days - rested, drank fluids, symptoms resolved with 36 hours Mild headache - onset approximately 12 hours post-injection, occasionally over 2 days - took Tylenol every 6 hours as needed, symptoms resolved within 36 hours Nausea and bloating - onset approximately 57 hours post-injection - Pepto Bismol, Gas-X - symptoms continuing now Vomiting - onset approximately 60 hours post-injection - still feel like vomiting now Epigastric pain, right side - onset approximately 60 hours post-injection - symptoms continuing now Feel clammy and dizzy
I experienced progressive ascending numbness that began in my hands and feet over the course of several weeks, including oral and saddle paresthesia. I have altered vision and balance during this course and ultimately had 2 doctor visits, two emergency department visits, a neurology visit and multiple tests performed (see item 19). The final diagnosis was a variant of Guillain Barre Syndrome.
Patient felt dizzy approximately 10-15 minutes after administration of vaccine. Patient started feeling better after 5 to 10 minutes. She waited in office for a total of 1 hour before going home. She said she felt like she was back to baseline.
sudden scream unconsolable became ashen; last prolonged period, poorly responsive, t101.4 in office;