chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tendonitis in shoulder muscles from 2 days after the shot for a period of about 3 months.  Pain is at the location of the shot.  This same thing happened last year in the other arm.  Twelve years prior to these two events, there were no problems (soreness only) with the flu shot after one week. 8/2/07-office note received. Patient not seen on 10/14/06 but seen on 4/20/07-C/O pain in right shoulder from flu shot. Right subacromial pain when actively moved. Gradual onset of shoulder joint pain, worse on rising. Feels better after normal movement. Causing inability to sleep and lying on affected side. Increased by raising arm in any direction. PE: tenderness and warmth over lateral apect of right shoulder. No tenderness over tendons. Normal movement of extremities. DX: Myalgia and myositis in right shoulder after flu shot. It happened a year ago in the left shoulder with flu shot. Follow-up: Given Flu Shot on 10-12-2006 at drug store, a day or two after the shot was administered my right shoulder became sore where the shot was given. After a few weeks the frequency and amount of pain increased. Periodic and daily pain, similar to a muscle strain or nerve reaction, have persisted for 8 months. After 6 months I went to my doctor and he said it was a reaction to the preservative in the flu shot, and not to take any more flu shots. A similar event happened with the 2005 flu shot that I took, but the symptoms and pain ceased after about 4 months.
pt recvd vax & 14JUN95 hepatitis B antigen positive;pt tested core E antibody neg;hepatitis B E antigen neg & anti-HBe neg;pt was not treated;3 repeat tests of hep B surface antigen were neg;
Left side general jaw pain. Neck and lymph nodes. Pain when chewing on that side. Dentist confirmed not tooth issue. Pain persists 6 days after  injection.
This may not be related but, the fatigue associated with my autoimmune disease had been well-controlled for 11 months through the oral biologic treatment Otezla. Three weeks post vaccination, I'm starting to have the same fatigue as before when my autoimmune disease was untreated. I did experience some fatigue in the days following the second injection but, this is different. This is the debilitating fatigue that interferes with my daily life. I realize this may not be related but, I know people with autoimmune diseases were not part of clinical trials. I am just submitting my experience in case others report the same.
The following is an email the patient wrote to us describing his events:  I received Moderna Covid Vaccine on January 4, 2021 and February 1, 2021 at Medical Center in  On the evening of January 12, 2021, I arrived home from working as a Pharmacist following a 13 hour shift at Medical Center with no medical complaints.  Later that night I experienced a severe coughing, sneezing episode where I was gagging on the mucous. I spit out a bunch of stuff and did a nasal rinse. I took some cold medicine like Certrizine and Mucinex-D.  Simultaneously with the coughing episode I developed a tingling sensation on the right side of my body from my neck to my toes. I also noticed that my temperature sensations on my right hand was different from my Left hand. I had gotten a water bottle from my refrigerator that felt room temp to my right hand but was cold when held in the left hand. I was feeling dizzy or drunk and was walking funny. When I tried to walk straight forward I actually drifted to the left as I walked. I was having difficulty swallowing medications, food or liquids.   I wondered if was experiencing the onset of Covid Symptoms. I was well enough versed on stroke symptoms to be worried about one sided tingling and altered gait being from a stroke.  The flu like nasal symptoms and altered right sided pain and temperature sensations persisted through the night, so I went to the ER at Medical Center the morning of January 13th. The ER worked me over with multiple Covid/Strept/Flu tests, evaluation for possible stroke (with multiple scans and stroke score.) The ERP also evaluated the possibility of Bells Palsy or Guillain Barre secondary to Covid vaccine the week before.  The Covid Testing was Negative. The stroke score was low enough NOT to have warranted thrombolytic therapy. The neurological issues did not appear to be Bells palsy or Guillain barre.   After the ER Visit I attempted to see a neurologist. May 25, 2021 was the earliest available appointment that I could obtain. The symptoms were not severe enough to prevent me working as a Pharmacist. The altered pain and temperature sensations remain without much improvement even now 4 months later.  The Neurologist diagnosed me as having had a stroke, specifically left sided Lateral Medullary Infarct, also known as Wallenburg Syndrome.   There have been reports from the other vaccines having caused blood clot issues since my event.
Redness, pain, swelling, warmth & itching @ inject site, hives & generalized itching for 12 days post inject w/h/a & nausea;
Erroneously administered first dose of rotavirus vaccine to a 7 mo; guidelines recommend first dose be administered no later than 4 months of age.
Fever on 1/12, followed by dizziness, nausea, extreme fatigue, and vomiting starting 1/13
I am 12 weeks pregnant, due September 19, 2021. This is my first pregnancy and I had my doctor?s approval to get the vaccine. I have had no complications so far in my pregnancy. On the day after receiving the vaccine, I developed a severe headache, congestion, dehydration, and fatigue. I felt feverish and had chills, but I did not have a fever. I was unable to go about my daily activities (I was not working on this day). These symptoms went away about 36 hours after being vaccinated. I also had pain at the injection site.
Fever,chills, muscles locked up from left shoulder across top of back to right arm. I couldn't move barely or life myself up. 2nd day after still sore when use arms, runny nose cough is worse. Fatigue,body aches
This spontaneous report as received from a nurse practitioner refers to an 11-year, 9-month-old male patient. The patient did not have any pertinent medical history, drug reactions or allergies. On 21-AUG-2017, the patient was vaccinated with the first dose of GARDASIL 9 injection, intramuscularly (lot # reported as M12093 with expiry date on 13-JAN-2020) to prevent human papillomavirus. Concomitant therapies included MENACTRA and ADACEL. On the same day, within 1 minute of receiving the GARDASIL 9, the patient experienced tonic clonic seizures, which lasted approximately 2 minutes. No treatment was given for the event and no laboratory diagnostic studies were performed. The patient sought an unspecified medical attention. The outcome of the event was considered as recovered/resolved on the same day. The relatedness between the event and GARDASIL 9 was not reported. Upon internal review, the event of tonic clonic seizures was determined to be medically significant. Lot number M12093 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast).
Fever soreness at injection site and arm, feels warm Narrative:  No OTC meds necessary, just began.
Patient reported having heart palpations, increased temperature, lips feeling funny,  and labored breathing after receiving Moderna vaccination.  Patient was given Benadryl twice , initially then  20 minutes later.  Pharmacist check on Patient every 5 minutes, fever fluctuated. Patient was notified that we have an Epipen that could be used but she declined.  Pharmacist offered to call ambulance but she refused.  Patient left observation area on her own accord.  Pharmacist called Patient to check on her and she said that she was much better, fever back to normal, labored breathing and heart palpitations  decreased.  Pharmacist told Patient that she would call to check on her in a few days.  Patient says that she does not have a primary care physician.
19AUG98 rt arm swollen & sore to touch;swollen from elbow to shoulder pt stated;20AUG98 seen by MD;pt states MD stated pt had pneumonia vax less than a yr ago-pt unsure of prev vax;
"I am reporting a reaction to my second Moderna vaccine given on 02/05/2021 around 10 AM . Initial headache/nausea/tiredness started on 02/06/2021 and lasted for 3 days. Missed work on 02/08/2021 due to nausea/HA /tiredness. Slight Headache alone for another 4 days- through 02/12/2021. On Saturday (02/13/2021) I started feeling a bit ?off?. I was having trouble remembering things and just in general feeling slow and not right. My husband was concerned, and I was frustrated. He was checking me for TIA symptoms. Sunday I had a mild HA ( 3-4 pain scale) but it did not bother me too much. Monday 02/15/2021 I would not have been able to work if I was scheduled- nausea/HA (level 8) with visual migraine aura. I had to go to bed. I slept for 5 hours. Again today 02/16/2021. I am leaving work early because I have nausea/HA (level 8) with pressure and having trouble focusing. Feels a lot like the migraines I had 20 plus years ago. Please let me know if you have any additional questions."
This spontaneous report as received from a healthcare worker refers to her son: a 13-year-old male patient with atrioventricular block first degree. Healthcare worker reported the patient received GARDASIL on 15-AUG-2013, as the first dose, on 21-OCT-2013, as the second dose and in 03-MAR-2014 for the third dose of the vaccination series. The patient did not receive any concomitant medication and did not have any allergies.  On 28-JUL-2015, the patient was vaccinated with GARDASIL 9 0.5 ml (route of administration, lot number and expiration date were not reported) and experienced pain at the injection site, immediately following the injection. There was no lab diagnostics study performed. There was no Product Quality Complaints involved. The outcome of the event was reported as resolved within an unspecified time frame. The relatedness between the event and GARDASIL 9 was not reported. Additional information has been requested.
patient does not come before the six months for the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 6th April 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.    Additional Information: GSK Receipt Date: 17-Oct-2022 Reporter's comment: The registered pharmacist had a chat and a question about Shingrix dosing. The registered pharmacist asked what happened if the patient did not come before the six months for the second dose, did the patient needed to repeat the first dose. The reporter consented for follow-up via postal. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (lot # and expiration date unspecified) injection, subcutaneous route. The pharmacist reported that on an unknown date the patient developed an injection site reaction after receiving ZOSTAVAX, that was described to be like a "big welt or target" that itched but was not reported to had been a rash. The pharmacist stated that three other patients had similar reactions. The outcome of injection site reaction and injection site itching was unknown. The causality was unknown. This is one of several reports from the same source (MARRS 1308USA006743, 1308USA010307 and 1308USA010308). Additional information has been requested.
Painful site almost immediate. Headache, body aches, fatigue, 16 hours after injection.
2/17/2023 I had cold symptoms. I had a stuffy and runny nose. Very minor cough and a fever of 102 that lasted most of the night. On 2/18/2023 I had a positive COVID PCR test. My fever was only 99 degrees. I lost my sense of taste and smell which only lasted a few days. My taste and smell are back but muted. I took many types of cold medications. I have been having weird pains in my back and upper quadrant on the front. I went to the doctor, and he suggested it could be my gallbladder. I had bloodwork which was normal. I am going tomorrow for an ultrasound. I continue to have the pain.
Cellulitis flare up; A spontaneous report was received from a Pharmacist concerning a 78 year  old female patient, who received second dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced Cellulitis flared up.  The patient's medical history included Cellulitis for 15 Years. No relevant concomitant medications were provided.  On 07 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 027L20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.   On an unspecified date, the patient experienced cellulitis that was aggravated after vaccination. The event cellulitis was considered medically significant.  No Laboratory details were provided.   The Treatment medication included Cephalexin 500 mg twice a day.  Action taken with mRNA-1273 in response to the other events was unknown.  At the time of this report, the outcome of the event, Cellulitis aggravated was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Had significat tinnitus in both ears 3 days after first COVID vaccination.  This has not gone away.
My brother was admitted to the hospital 2 weeks after his last vaccine. There was NOTHING wrong with him prior to the shot. He went in for respiratory problems. He's was having a hard time breathing. He recovered from that, and then died from organ failure, again, never having other problems before.  I know from visiting that other spinal cord patients were in the hospital at the same time with the same issues. I knew that two of them not including my brother also died. These vaccines are NOT safe for everyone!!
NAUSEA; CHILLS; FEVER; EMESIS 5 TIMES OF YELLOW FLUID; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced emesis 5 times of yellow fluid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 09-MAR-2021, and chills, fever, and emesis 5 times of yellow fluid on MAR-2021. This report was non-serious.
Acute Tinnitus. Ringing in the Ears which began shortly after the 2nd injection on June 29 2021
arm pain; fall asleep; Discomfort; General body pain; feeling like a truck ran you over and over and over; This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DIPHTHERIA TOXOID + TETANUS TOXOID (TD) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and TD. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm, sleeplessness, discomfort, general body pain and feeling abnormal. The patient was treated with paracetamol (Tylenol) and ibuprofen (Advil). On an unknown date, the outcome of the pain in arm, sleeplessness, discomfort, general body pain and feeling abnormal were recovering/resolving.   It was unknown if the reporter considered the pain in arm, sleeplessness, discomfort, general body pain and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient both arms were achy but right arm hurt worse, hard to fall asleep with the discomfort. The patient stated that what was worse was the all over body ache I had when I awoke. The patient felt like a truck ran you over and over and over from top to bottom. The reporter was did not agree to follow up from GlaxoSmithKline.
Patient received vaccine Thursday 1/21/21 and experienced headache and fatigue for two days.  By Saturday, her symptoms began to improve.  On Monday 1/25/21, the patient developed a petechial rash around the injection site and noticed sores on her gums and the patient went to OR.  Evaluation at outside ED showed a platelet count of 2,000 with a normal H/H.  Patient was transferred to our hospital for increased level of care, hematology consult and platelet transfusions.  Significant hematology workup with a clinical picture thought to be consistent with ITP.  Patient started on dexamethasone 40mg and received IVIG x 3 doses and platelet counts have started to improve
Her forehead hurts; 7 year old patient / given an adult Hepatitis-A vaccine / was given an adult dose of the vaccine; 7 year old patient / given an adult Hepatitis-A vaccine / was given an adult dose of the vaccine; This case was reported by a nurse via call center representative and described the occurrence of forehead headache in a 7-year-old female patient who received HAV (Havrix adult) (batch number Y29KL, expiry date 21st February 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st March 2021, the patient received Havrix adult (intramuscular) and Havrix Pre-Filled Syringe Device. On 31st March 2021, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the patient experienced forehead headache. On an unknown date, the outcome of the forehead headache, overdose and adult product administered to child were unknown.   It was unknown if the reporter considered the forehead headache to be related to Havrix adult and Havrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: This case initially considered as invalid but upon follow up, it was confirmed to be valid. The patient was the patient's mother. The reporter stated, the patient had received hepatitis A vaccine from her health care professional in an unknown arm. The patient had received 2 vaccines on that day (other vaccine was not specified). It was later confirmed that, the patient received adult Havrix which led to adult product administered to child and overdose. The reporter stated that, the patient said for the past several days, her forehead hurt.  She was not sure that the patient might had bumped her head while playing.  The reporter did not consent to follow-up. Note- the onset date for headache was provided as 7th April 2021 however the patient's mother reported on 5th April 20201 and mentioned that, the patient said her head was hurting for several days, TTO kept as less than a week instead of 7 days.
received both doses when age 16; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received both doses when age 16) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Medical history was not provided.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received both doses when age 16). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received both doses when age 16) had resolved.            No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.  It was reported that her twin granddaughters received both doses of the Moderna Covid-19 Vaccine earlier this year when they were just 16 years old. She is now looking to get the 3rd dose for both but cannot find anyone to give them. This granddaughter received her 1st dose in late January/early February (unsure of exact dates because she does not have the vaccination card)
Vomiting, diarrhea, chills, dizziness, nausea, fever,  and fatigue. for 3 days after the vaccine was administered. Day 4 some headache and nausea
Went to sleep at 9 pm, woke at 12:30 am violently sick, convulsing, hyperventilating, and nauseated. Had very intense and strong muscle, joint, and head aches. Was shivering uncontrollably. Was unable to sleep or do anything except vomit and shiver. This lasted 12 hours.
Cessation of monthly menstrual cycles following vaccination. Cycles were regular prior to vaccination; no other signs of peri-menopause. Cycles have not restarted as of 3 months following vaccination. Abnormal hair loss started about one month after vaccination and is ongoing.
This spontaneous report was received from a medical assistant concerning a 12 year old male patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  On 30-MAY-2017, the patient received the first dose of GARDASIL 9 (dose, route, lot number and expiration date were not reported), and on 21-JUN-2017, the patient received the second dose of GARDASIL 9 lot number M041990, expiration date 28-JUN-2019 (dose and route were not reported) both for prophylaxis. Both vaccines were administered too close together. No adverse effects were reported. Additional information has been requested.
Immediately after patient received the vaccine she briefly fainted. After approximately 30 seconds the patient awoke and was feeling groggy. We had the patient lay down and elevated her feet. She recovered and within fifteen to twenty minutes said she felt fine and departed.
syncope; POTS; autonomic dysfunction; orthostatic intolerance; fatigue; dizziness; headache; This spontaneous report was received from a lawyer regarding a case in litigation concerning a 13-year-old female patient (pt). Information on the pt's concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the pt was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. Following vaccination, in 2013, the pt experienced Postural orthostatic tachycardia syndrome (POTS), syncope, orthostatic intolerance, autonomic dysfunction, fatigue, headache, and dizziness. The outcome of the events was not provided. The reporter stated that the events were deemed or should had been deemed causally related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccination. This is one of multiple cases from the same reporter.  Upon internal review, Syncope was considered a medically significant event.; Sender's Comments:  US-009507513-2301USA006946: