chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever, chills, body aches, headaches, shaking, nausea, muscle and joint pain, fatigue, injection site soreness, swelling below site, redness, tender and tingling in upper arm . Most symptoms occurred early am 2/5 4-5 hours all at same time, relief with Tylenol and Ibuprofen. Chills and aches remained throughout day. Fatigue continued 2/6/21. Redness swelling tenderness and tingling in arm below injection site remains.
Hives on R/arm on arm administered, L/arm thereafter.  Dizziness.
Patient called on 9/17/19 reporting swelling at the site of injection. She stated that it was raised, swollen, and hot to the touch on the date of injection. When she woke up on 9/17 the swelling had gone down at the injection site, but the whole upper arm was significantly swollen, red, and tender to touch.
24 hours later patients left arm swelled, but he recovered then he noticed a tennis ball-like ball bulging from the elbow. He was administered shot on 8/6/11 but came into pharmacy on 8/24/11. I told him to see the MD right away. He said he doesn't have pain/but uncomfortable. Patient believes maybe he hit his elbow at work, he is a contractor. Since it happened 24 hrs. later I wanted to report this.
Narrative:  70yo patient had received the covid vaccines on 3/30/2021 & 4/28/2021. On 8/28/21 pt went to community hospital (NON_AGENCY hospital) for chest pain & found to be covid positive with covid infection. Pt remained inpatient at hospital. Pt then died at this hospital of covid infection. Failure of covid vaccines. Pt had the following problem list: 30 Problems ST PROBLEM LAST MOD PROVIDER A Leukocytosis (SCT 111583006) (ICD-10-CM D72.829) 08/16/2021 A Hyperparathyroidism (SCT 66999008) (ICD-10-CM 07/23/2021 E21.3) A Chronic kidney disease (SCT 709044004) 07/23/2021 (ICD-10-CM N18.9) A Gout (SCT 90560007) (ICD-10-CM M10.9) 07/23/2021 A History of calculus of kidney (SCT 429025008) 07/23/2021 (ICD-10-CM N20.0) A Joint pain in left hand (SCT 1076731000119106) 07/22/2021 (ICD-10-CM M25.542) A Pain in right foot (SCT 316891000119107) 07/22/2021 (ICD-10-CM M79.671) A High risk drug monitoring status (SCT 243872007) 07/22/2021 (ICD-10-CM Z79.899) A Secondary Sjogren's syndrome (SCT 239915006) 07/22/2021 (ICD-10-CM M35.00) A Low back pain (SCT 279039007) (ICD-10-CM M54.5) 07/22/2021 A Adjustment disorder with anxious mood (SCT 02/25/2021 47372000) (ICD-10-CM F43.22) A Obstructive sleep apnea of adult (SCT 09/14/2020 1101000119103) (ICD-10-CM G47.33) A Cardiomyopathy (SCT 85898001) (ICD-10-CM I42.9) 09/12/2019 A Chronic obstructive lung disease (SCT 13645005) 10/23/2017 (ICD-10-CM J44.9) A Raynaud's phenomenon (SCT 266261006) (ICD-10-CM 08/10/2017 I73.00) A Ischemic heart disease (SCT 414545008) 11/22/2017 (ICD-10-CM I25.9) Stents x 2 A Knee pain (SCT 30989003) (ICD-10-CM M25.561) 12/01/2015 A Costal chondritis (SCT 64109004) (ICD-9-CM 02/10/2015 733.6) A Other diseases of lung (SCT 427359005) 11/22/2017 (ICD-10-CM R91.1) A (ICD-10-CM K21.9); Gastroesophageal reflux 11/22/2017 disease (SNOMED CT 235595009) A (ICD-10-CM R 91.8); Abnormal findings on 04/28/2017 A diagnostic imaging of lung (SNOMED CT 274533004) Abnl density in abd/pelvic ct scan 07/2013, f/u 3 months A Health Maintenance (ICD-9-CM 799.9) 07/06/2015 1. Tdap 08/2013 2. Pneumovax 07/2013 3. fobt neg 1/2014 4. Psa 1/2013 A (ICD-10-CM Z95.0); Cardiac pacemaker in situ 01/06/2016 (SNOMED CT 441509002) A (ICD-9-CM 301.9); Unspecified Personality 08/15/2012 Disorder A Major Depression, recurrent (SCT 66344007) 10/15/2015 (ICD-10-CM F33.9) A (ICD-9-CM 302.72); Erectile Dysfunction * 04/05/2002 (ICD-9-CM 302.72) A (ICD-10-CM E78.5); Hyperlipidemia (SNOMED CT 01/06/2016 55822004) A Arthritis, Rheumatoid (SCT 69896004) (ICD-10-CM 02/19/2016 M05.9) A Essential Hypertension (SCT 1201005) (ICD-10-CM 10/03/2016 I10.) A Chronic osteomyelitis involving multiple sites 08/30/1999 (ICD-9-CM 730.19)
That evening, patient experienced itching, warmth and rash at the injection site.  A large red welt developed over the injection site that evening and she came to show me the following Monday that the welt remained, but the itching had subsided some.  She had been taking diphenydramine after speaking with her daughter who is in pharmacy school over the weekend. No other generalized reaction was noted.  The welt subsided over one week.
High Blood Sugar; High Blood Cholesterol after COVID-19 vaccination; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (High Blood Sugar) and BLOOD CHOLESTEROL INCREASED (High Blood Cholesterol after COVID-19 vaccination) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLOOD GLUCOSE INCREASED (High Blood Sugar) and BLOOD CHOLESTEROL INCREASED (High Blood Cholesterol after COVID-19 vaccination). At the time of the report, BLOOD GLUCOSE INCREASED (High Blood Sugar) and BLOOD CHOLESTEROL INCREASED (High Blood Cholesterol after COVID-19 vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-103362 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-103362:
PATIENT AGE WAS 17 YEARS. . MOM HAD MARKED MODERNA ON PAPER AND HAD VERBALLY REQUESTED THAT AND VACCINATOR DID NOT CATCH THAT THE PATIENT WAS ONLY 17.  MODERNA VACCINE WAS ADMINISTERED. DISCUSSIONS HAVE TAKEN PLACE WITH MOM MAKING HER AWARE SHE SHOULD NOT HAVE BEEN GIVEN MODERNA. SHE HAS NOT HAD ANY REPORTED SIDE EFFECTS.
35 minutes after injection.  Dizziness, nausea, irritable, vertigo, flushed.  Felt better after several hours.
Rec'd TD 2/10/05 at 12PM c/o small knot size of pea approx 24 hrs later. Pt states site grew larger and more painful. Pt c/o itching, soreness, and tenderness. Site measured today 80mm site hot and tender to touch.
Patient was admitted from PCP for extreme tachycardia and tachypnea and developed multi organ involvement with tachycardia (HR to 140-150s), slight elevation in BNP (H of 490), Troponin (H of 0.244), mild proteinuria (50-70 proteins),  respiratory distress with tachypnea (RR 50s) and hypoxia requiring escalation in O2 supplementation. Also with daily fevers until starting steroids. Laboratory findings concerning for slight hypertriglyceridemia, normal Ferritin, worsening thrombocytopenia, lymphopenia, hyponatremia, and hypoalbuminemia.  CT with bibasilar atelectasis vs. consolidation, but no evidence of PE. Extensive ID and rheumatological evaluation performed and unremarkable so far.  Received 2 days of Doxycycline. Was started on pulse dose steroids and began to show improvement in all markers.
Tired/Exhaustion about 2 hours after, lasting through the next day (not yet at 24 hours post-vaccine); sore throat, started about 12 hour after and still going the next day; sore arm, started about 4 hours after and still going the next day
Pfizer-BioNTech COVID-19 Vaccine EUA  Symptoms started to occur approximately 10 min after injection. Symptoms included tingling sensation in face and brief period of lip numbness. I did not have any rash or respiratory issues. All noted symptoms resolved within 1 hour without any medication. I initially did not report these issues to the pharmacy where I received the shot.
01/24/22 presents to ED for "abdominal pain". PMHx of "multiple abdominal surgeries" "GERD and PUD, intussusception, chronic abdominal pain, pancreatitis, HTN, HLD, DM, kidney stones, seizures."
Received one dose Bexsero. Do I need a second dose?; This case was reported by a consumer via interactive digital media and described the occurrence of inappropriate age at vaccine administration in a 69-year-old patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concurrent medical conditions included splenectomy.   On an unknown date, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-May-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient was 69 years old at the time of reporting. The patient received 1 dose of Bexsero at not the recommended age. The patient asked if 2nd dose was required or not. Additional Supportive Information: The patient received Bexsero at not the recommended age, which led to inappropriate age at vaccine administration.
It was reported, "A physician reported that a 2 month old female received her 1st dose of Rota Shield, as well as, DTAP, IPV and Comvax vaccines on 6/18/99. The infant became fussy and had loose stools. The infant was seen by the physician on 6/24/99, who noted that the infant developed diarrhea described as 2 foul-smelling bowel movements per feeding. The diarrhea persisted and the infant was seen by the physician on 6/28/99; she had lost 1 ounce since 6/24/99."
3 days after the shot, I experienced menstrual cramping and bleeding two weeks before normal period start date. Four days of unusual spotting, discharge, and cramps have followed. Black discharge with a foul smell. I know this is highly unusual for my body. No other stressors and no history of irregular period. I will see my doctor soon, but my bloodwork from a few months ago was normal. I'll continue to monitor, but this is a concerning side effect and I hope it is temporary. I wish I'd known this was a possibility.
patient became lethargic and briefly passed out 1 minute after receiving vaccine.  Patient did not have swelling or breathing problems so an epinephrine pen was not needed.  Patient became sweaty and had muscle rigidity of her hands and arms.  Patient had rapid heart rate and extreme exhaustion.  Ambulance was called and patient care was passed off to the EMTs and the hospital.
Appetite changes and fever and soreness in muscles. cough. breathing issue, having trouble taking deep breath. headaches. night sweats. within 7-10 days I could not put any pressure or weight on my left foot which was swollen, and my upper leg muscle was sore. I did an ultrasound on my leg to check for blood clots. I was also told I had a sinus/ upper respiratory infection. I still have fever off and on. the soreness continues.  Upper part of both legs is sore. Compression socks were prescribed.  Indigestion and no apatite persist. Weight loss. Tylenol for fever.
Pt phoned to say she was having a reaction at injection site of flu shot. She states about 1/2 hour after the infection she developed tenderness and felt that it was normal post injection. Today, she noticed she has a bruise, tendernes, redness, and it feels warm in the area surrounding the injection site. She denies fever, chills. PA-C advised pt take Tylenol as directed and Bendryl as directed, and also apply cold packs throughout the next 4 days. Pt advised to follow-up with her on Monday for evaluation if no resolution.
Pfizer Covid-19 Orange Top vials (Pediatric age 5-11) were diluted and administered following the Pfizer COVID-19 Purple Top vial (Adolescent age 12 and older) preparation and administration instructions. 1.8 ml was used to dilute the 1.3 ML vial instead of 1.3 ml. This would change the concentration to 130 mcg/3.1 ml = 41.9 mcg/ml The dose given out of this vial was 0.3 ml. The children (age 5-11) received 0.3 ml x 41.9 mcg/ml = 12.6 mcg. Pfizer Case #: int00506363
On 2/28/2021 while having lunch at noon he suffered an apparent heart attack.
Two days after injection (Thursday, April 7), the area of the injection site became inflamed and began to itch. I had developed a rash under the skin and welps  above the skin.  The area was the side of the palm of a hand. The vaccine site was warm and itched. I treated it with a topical gel that evening and the next day. The rash got better. Sunday, April10, I discovered a cluster of spots above my elbow and below the vaccine site. A second cluster of bumps or spots was below my armpit on the same area.
2am 2/12 began severe chills, lower leg severe aches, nausea, fever 103-104.5, uncontrolled by Tylenol around the clock. Fever returning at 2.5-3 hours back up to 104. By around noon-1 pm pain and chills unbearable. Mother called ambulance. While ambulance here vomited as soon as stood walking out after using the bathroom. Hot sweats. Heart rate 125 at ER.  Fever brought down by Tylenol, toradol, and Valium, followed by fever of 103  at home 1-2 times then low grade fevers of 100-101. 2/13 5 pm still nauseous, moderate headache, body  quite weak, only low grade fevers.
hives occurred approx. 7pm on 1/20/21, used hydrocortisone cream with resolution.  On 1/21/21 new hives appeared, used hydrocortisone cream - itching stopped.  On 1/22/21 2 more new hives used hydrocortisone cream with resolution.
lip and tongue swelling, subjective throat swelling, pruritis  epi 0.5 mg IM, benadryl 50 mg IV, solu-medrol 60 mg IV, pepcid 20 mg IV
Patient expereinced significant swelling of entireupper arm.  Initial visit to clinic MD believed it was infection.  Pt returned to clinic next day, and her primary care provider deemed it a localized allergic/adverse reaction. Received cephalexin, methylprednisolone, and loratadine.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) and FATIGUE (little tiredness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, 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 VACCINATION SITE PAIN (sore arm) and FATIGUE (little tiredness). At the time of the report, VACCINATION SITE PAIN (sore arm) and FATIGUE (little tiredness) outcome was unknown.            No concomitant medication was provided.  Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-374119, MOD-2021-374179 (Patient Link).
Both eyelids swollen, right eyelid significantly more swollen than the left, still able to see out of both eyes
Initial report was received on 08 April 2011 from a consumer and the following electronic lay press article. A 23 year-old male patient (also reported as 21 year-old) with no reported past medical history had received possibly in 2007 MENOMUNE A/C/Y/W-135 (lot number, route, site and date of administration not reported) and "on Friday" (01 April 2011) developed a sore throat, was achy and had flu-like symptoms that lasted through the weekend. He was evaluated by his physician on Tuesday and it was thought "it was just a regular virus". Later on Tuesday, the patient complained of being in the "worse pain of his life", he appeared swollen and had "bruise-like blotches" on his body. The patient was taken to the hospital and then transferred to another hospital. He was diagnosed with N-Meningitis serogroup unknown. Relevant diagnostic tests/laboratory data was reported as positive. Treatments were not reported. No further information was available at the time of the report. The patient's outcome was fatal. The cause of death was reported as bacterial meningitis on 06 April 2011 (also reported as 05 April 2011). Documents held by sender: none.
Chills, fever, inarticulate, headache, sore throat, diarrhea, and fatigue on 2/6.
difficulty with his usual activities including working out, weight lifting, and chores around the house; pain in his right arm; Initial information regarding an unsolicited valid non-serious case was received from physician and consumer/non-health care professional via Agency (Reference number- 00888436) and transmitted to Sanofi on 07-Dec-2021.  This case involves 65-year-old male patient who experienced difficulty with his usual activities including working out, weightlifting, and chores around the house (loss of personal independence in daily activities) and pain in his right arm (pain in extremity) while receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On 07-Oct-2021, the patient received 0.7ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number was not reported and expiry date: 2021/2022) (Frequency = once) via intramuscular route in the right arm for prophylactic vaccination.  On 07-OCT-2021 the patient developed a non-serious difficulty with his usual activities including working out, weightlifting, and chores around the house (loss of personal independence in daily activities) and pain in his right arm (pain in extremity) same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported "The caller reported adverse reactions since receiving the vaccine in October. The symptoms have improved but have not resolved. The caller would like to know if these reactions are normal and if we have any further information. He denied going to the Emergency Room. The caller reported that he cannot sleep on that side. The caller saw his primary care physician about 3 weeks ago. The physician informed the patient that the vaccine may have been inserted into a tendon or administered too deeply. The physician recommended that the patient wait to see if the symptoms improve over time. The caller noted that he has experienced some improvement in his symptoms, but that the pain is still impeding his daily life activities. No further information provided by the reporter".  No relevant laboratory data was provided.  The patient has used ice, Ibuprofen, and Diclofenac cream without relief.   At time of reporting, the outcome was resolving for the event pain in extremity and was not resolved for the event loss of personal independence in daily activities.  There will be no information available on the batch number for this case.
Unable to maintain my running regiment. Pain in lower limbs, diagnosed with neuropathy.  1/31/06 Review of 27-page medical record confirms neuropathy. Additional symptoms include: weakness in legs, numbness in feet, and fatigue. Per 60 day follow up report-my ability to run continues to deteriorate. My pace at which I run has also drastically slowed down. Also, the neuropathy condition in my left foot appears to be getting worse. Per annual follow-up: Running ability is much harder
3JUL97 pt exp SOB;x-ray revealed congestion in lower lung;MD  dx viral pneumonia;exp dyspnea on exertion;CXR revealed bibasilar infiltrates;tx med;dx interstitial lung disease,hypersensitivity pneumonitis & connective tissue disease;
High fever with chills, aches all over body, especially in places an injury occurred anytime in my life. Injection arm tender & sore to touch from elbow to shoulder & was slightly red around the injection site.  It felt like my body had been cut up into pieces & scotch taped back together with all the pain everywhere. Thirsty , mildly nauseated.  Thursday morning I ate 5 bites of cream of wheat made with water. I was mostly bedridden until Thursday 18th night; I was able to eat broth & noodle soup.  Continued in bed most of the time, began eating solid food Fri., mashed potatoes, crackers & vegetable salad. Still very tired. By Fri. 2/19/2021 I was beginning to regain my strength to more normal levels. I still needed 2 hour naps & slept 9-10 hours nightly. Still seemed I'd get a low fever, then break it for several days.  I started sleeping on the sore arm side, cuz it was so painful on the other side & on my back after several days in bed. My arm stopped hurting after 5 days3/1/2021 Today is my best day yet.  Happy to have the vaccine, no regrets!!! Thank you so much for that.
she developed a red rash from her knees to her ankle, and from the elbow to the wrist; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Right Arm on 03May2021 10:55 AM (Lot Number: ER8735) as 2nd dose, single for covid-19 immunisation. Medical history included ongoing diabetic (diagnosed at least 12 years ago), she has breathing problems (she is not allowed out in public even after her vaccination). The patient's concomitant medications included she has been taking the medicines now for a while, she did not feel like it was a reaction to any of that. Historical Vaccine included Patient gets a flu shot every year for immunization; she also received the first dose of BNT162B2 (at age of 78 years old, lot number: EP7533) on 31Mar2021 injected before noon at right arm for COVID-19 immunization. Patient has received both doses of the Pfizer Covid 19 Vaccine. The second vaccine was received on 03May2021. Patient reports that on 18May2021 she developed a red rash from her knees to her ankle, and from the elbow to the wrist. Caller denied stinging, pain, or burning. She also denied any changes to detergent. Caller asking if symptom has been reported. Patient calling to see if she is having a reaction to the Covid vaccine. Patient states she is calling because she at her wits end, she had her second shot on 03May2021 and maybe three days ago now, she started breaking out with a red rash, it does not sting, burn, or hurt but it was from her knees to her ankles and from her elbows to her wrist. Patient states thought everything they can think of and she has had no new laundry detergents or eaten no new foods. breaking out with a red rash: Caller states she would say this past Tuesday and it seems to be more predominant when she takes a shower, with the warm water it seems to bring it back out. Caller states she has been taking some Benadryl. Patient states like she says, its just there, it did not sting, it did not itch, it did not burn, she just looks down at her arm or leg and it was kind of weird looking. Pfizer Covid Vaccine: No Investigation Assessment. The event was not required a visit to Emergency Room nor Physician Office. Outcome of the event was not recovered.   Information on Lot/Batch number was available. Additional information has been requested.