chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hospital claimed "I had hematoma"; My foot swelled up enormously; Couldn't put my foot down on the floor in the morning; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TRAUMATIC HAEMATOMA (Hospital claimed "I had hematoma"), PERIPHERAL SWELLING (My foot swelled up enormously) and MOVEMENT DISORDER (Couldn't put my foot down on the floor in the morning) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Bruise (after a large shampoo bottle fell on left foot while taking shower) since 24-Feb-2021.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced TRAUMATIC HAEMATOMA (Hospital claimed "I had hematoma"), PERIPHERAL SWELLING (My foot swelled up enormously) and MOVEMENT DISORDER (Couldn't put my foot down on the floor in the morning). At the time of the report, TRAUMATIC HAEMATOMA (Hospital claimed "I had hematoma") and PERIPHERAL SWELLING (My foot swelled up enormously) had not resolved and MOVEMENT DISORDER (Couldn't put my foot down on the floor in the morning) outcome was unknown.        This case was linked to MOD-2021-075169 (Patient Link).
Pt states that 24 hours after being administered MMR, redness, itchy, warm to touch.
Patient received vaccine at 2:15 pm at Public Health clinic. She waited the appropriate 15 minute observation period and was feeling well. She then came to PCP office for a routine medical exam and reported feeling well when she first came, although her blood pressure was slightly elevated but pulse was normal. She was taken to an exam room and left for approximately 5 minutes, at which time she presented to the nurses station reporting that she thought her tongue may be swelling. Nurse evaluated and got NP to evaluate immediately. Patient reported she could still breath normally and swallow but that she was still feeling the swelling increase. At this time NP left to get PCP while nurse elevated HOB as patient began to choke on her tongue. PCP ordered epinephrine, 1 mL administered immediately. 911 called. Patient reported she was starting to feel better, swelling began to decrease. She then started to feel shaky, was pale and diaphoretic. She lost consciousness for approximately 10 seconds and pulse was not palpable. Staff readied for CPR and AED brought to room but patient regained consciousness prior to any care being necessary. She began to speak in full, clear sentences and was alert and oriented. 2L o2 applied. She was speaking with staff normally for around 5 minutes while awaiting ambulance, began to feel hot and felt her heart racing. Her PCP advised her that this was a normal sensation brought on by epi. As EMS arrived, patient reported feeling intense chest pain radiating down left arm, intense headache, and tingling in her fingers. As she was being transported to stretcher, patient experienced a 1.5 minute seizure followed by an episode of vomiting. She then left the building via ambulance and was take to Hospital emergency department. There it appears that she received 2 more rounds of IM epinephrine, IV epi, CPR, and was intubated. She was transferred from there to ICU where she is currently admitted on ventilation under sedation and receiving cardiac testing due to continued hypoxia and tachycardia.
2nd dose given May 11 2021.  June 28 2021 experienced first ever lifetime episode of syncope (fainting) accompanied prior to event with severe nausea.   Was unconscious approximately 30 seconds, profuse sweating.  No vomiting occurred after syncope event.  Syncope resulted in a slight concussion due to hitting a wall on the way down.  Prior to the syncope event I had been experiencing heart palpitations with some regularity, but I have a history of palpitations that have been exacerbated recently by perimenopause.  Since approximately mid-July 2021 brain fog, difficulty finding the correct word when speaking at times, often will use the opposite word than intended meaning.  This does not occur with writing or typing, only speaking.  This has continued through present day.
04/08/2022 vaccination. 05/19/2022 Attended an outdoor event. 05/20/2022 Started to get a little runny nose, congested. Scheduled COVID test. 05/22/2022 COVID-05/25/2022 COVID positive (home test).
It started a week after having the 2nd vaccine. I started itching at the nape of my neck near my hairline. I gradually started going down, my back. It started around my knees and ankles. My pharmacist recommended that I have an allergy test done due to taking large amounts of hydroxyzine HCL. I went and had allergy test done and I was advised that I was allergic to wheat, soy, pecan, and peanuts. They completed a procedure called rush where they gave me 66 allergy shots within an 8 hour period. My body was able to manage all the allergens. I have to get allergist shots every 2 weeks for at least a year. I have an autoimmune disease psoriasis. I do not take oral medications, just creams and ointment. The doctor believes that the vaccine went in and messed around with autoimmune disease. I was diagnosed with psoriasis and multiple new allergies. My condition has not improved. I currently have to put aloe Vera on my body multiple times a day due to itching. Dr. (internist) took 6 vials of blood to make sure it is not my liver or pancreas.
Sore muscle in left arm at site of injection for 2 1/2 days starting the day after on 1/11/2021 Headache lasting for 2 /12 weeks almost daily starting the morning of 2/11/2021, the day after the injection Fatigue and unusually tired in body and spirt  for 3 weeks starting the day after the injection on 2/11/2021
7 days of joint of muscle pain preventing getting out of bed. hurts to lay in be at a pain level 10/10.  Headach lasting for 3 weeks straight, different in severity and pain location and type when compared to migraine. Unable to preform ADLs for over three weeks. TX with Toradol with no relief.
Patient developed a feeling of being light headed, became flushed and then felt short of breath.  Patient reported feeling as though her throat were closing.
Flu vaccine administered 9/27/10 developed local tenderness, swelling and warmth at injection site within 48 hrs.
Dupuytren's contracture; Herpes Zoster Radiculitis; Post Herpetic Neuralgia; Post herpetic neuritis; chronic pain; Information has been received regarding a case in litigation from a lawyer and refers to a patient of unknown age and gender.  No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 08-NOV-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route, lot # and expiration date was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine (date not reported), the patient suffered from and had been diagnosed with Herpes Zoster Radiculitis, Post Herpetic Neuralgia, Post-herpetic neuritis, chronic pain, and Dupuytren's contracture. The patient experienced recurrent herpetic rashes, pain, and symptoms related to her injuries, which have been ongoing for eight years. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered not recovered. All the events were considered to be related to zoster vaccine live (ZOSTAVAX).  Herpes Zoster Radiculitis, Post Herpetic Neuralgia, Post-herpetic neuritis, chronic pain, and Dupuytren's contracture were considered to be disability events. Upon internal review, Dupuytren's contracture was considered to be medically significant.
Approximately three weeks after receiving first Shingrix vaccine, I developed painful rash on my left hand and left elbow, mild numbness on my left arm, and mild pain in my armpit.  It was diagnosed as shingles this morning.  I was given Valacyclovir, 1 gram tablet (3x a day for 7 days).
Received vaccine past published expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past published expiry) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050e21a) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past published expiry). On 16-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received vaccine past published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.
1 of 3 pts w/in a 1 wk period who exp an inj site rxn consisting of redness & swelling following vax
Fever between 101-102 for 36 hours.; Fever between 101-102 for 36 hours, along with chills.; Headache; Fatigue; Ringing in ear; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the arm left on 15Apr2021 at 10:30 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included long COVID hauler (2 confirmed separate COVID cases). Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included amitriptyline (AMATRIPLINE) and thyroid medication (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient had allergies to medications, food or other products (unspecified). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm left on 25Mar2021 at 10:30 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 18:30, the patient experienced fever between 101-102 for 36 hours, along with chills, headache, fatigue and ringing in ears. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever between 101-102 for 36 hours, along with chills, headache, fatigue and ringing in ears were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
48 Hours after severe headache, muscle and joint aches low grade fever. Chest pressure and throat tightness occurred, cough associated and phlegm, low energy and upper back pain. Symptoms increasing gradually.  Spouse is not experiencing same symptoms after 24 hours
8 days after injection developed a red raised area, around 3 inch round area.  It is a little itchy and sensitive to touch.  No other symptoms.  It is now  6 days since onset and a little better.
The patient had three dosis of the vaccine before the administration. She has Cancer and its receiving treatment. The patient is classify as immunocompromised. The dosis that should be administrated was a Booster of Moderna (0.25mL). The dosis administrated to the patient was a full dose of Moderna (0.5mL).
This case meets criteria for vaccine breakthrough review. SxS include SOB, body aches, myalgias, cough, weakness.  Known family exposures.
hardness/swelling on her arm; Vaccination site warmth; Vaccination site pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING (hardness/swelling on her arm), VACCINATION SITE WARMTH (Vaccination site warmth) and VACCINATION SITE PAIN (Vaccination site pain) in a sixty-two-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (Batch no. 0131B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On 18-Apr-2021, the patient experienced SWELLING (hardness/swelling on her arm) and VACCINATION SITE WARMTH (Vaccination site warmth). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Symptomatic treatment, at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, SWELLING (hardness/swelling on her arm), VACCINATION SITE WARMTH (Vaccination site warmth) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment:  ice
99.9 temperature Fatigue Cluster headache Muscle pain Joint pain GI cramping for approx 24 h Required to stay home from work
Immediately following shot my blood pressure drop felt like I was going to faint. With in a couple hours sore arm at injection site. With in 12 hours headache, slight fever achy body. 24 hours in my arm pit on the same Injection arm was swollen and uncomfortable and has remained so for 4 days so far.
Exacerbation of fibromyalgia symptoms.  Severe muscle and joint pain.  Headache. Increased fatigue times four days.
began having itching inside ears and tongue, without tongue swelling; intermit cough within about 5 minutes after administered.  Pt took 25mg of personal benadryl.  Pt continually monitored for 30 minutes following benadryl administration.  Cough resolved after 10 minutes, other symptoms remain unchanged.  25 minutes following benadryl, patient stated symptoms resolved.  Pt monitored another 5 minutes, vital signs rechecked.  Pt sent home with spouse in stable condition.
Allodynia, hyperalgesia, Universal joint pain, exaggerated symptoms of ongoing CRPS in all four extremities. Continued moderately severe pain almost 2 weeks out
large red swollen area in the injection site; large red swollen area; itched; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (large red swollen area in the injection site), INJECTION SITE SWELLING (large red swollen area) and INJECTION SITE PRURITUS (itched) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ANASTROZOLE (ARIMIDEX) for Breast cancer.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (large red swollen area in the injection site), INJECTION SITE SWELLING (large red swollen area) and INJECTION SITE PRURITUS (itched). At the time of the report, INJECTION SITE ERYTHEMA (large red swollen area in the injection site), INJECTION SITE SWELLING (large red swollen area) and INJECTION SITE PRURITUS (itched) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) High.         No treatment medication was reported.   Reporter did not allow further contact
From Dr.  notes from the patient's visit to the office on 02/08/2021:   "*ACUTE CELLULITIS OF THE RIGHT UPPER ARM--I do believe that this is a result of the injection and not due to the vaccine itself. The fact that he continues to have some slight growth does necessitate that we treat this with an antibiotic. I am what have you TAKE TMP-SMX DS 1 tablet twice per day for 7 days. Elevate this arm and keep moist heat to this area and it should improve quickly. Call me if there is any worsening. I will CHECK COMPLETE BLOOD COUNT TODAY to evaluate this more fully."  Also from Dr. notes from the patient's visit to the office on 02/08/2021:   "This fine lady comes in today stating that she received the CoVid 19 Moderna vaccine with the first dose on 2/2/21. The patient previously had a moderately severe case of CoVid 19 in late September and early October. She states that the vaccine did cause her to have severe chills for 2 days and then she started to develop an area of erythema near the injection site and this continued to progress. She called me on Friday in regards to this and then on Saturday it had continued to grow. We did have her husband demarcate the borders of the erythema and today it seems like she has had another further growth of an inch or so in most directions. The patient has a little tingling in this area but really has no significant pains and she denies any fevers since she had fever on Thursday night and Friday with a temperature of 102."
severe headache; "ice-pick", sharp stabbing headaches that come out of no where; "ice-pick", sharp stabbing headaches that come out of no where; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Dec2020 (Lot number: EK5730) at the age of 24 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "PCOS" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing); "tension", start date: 2015 (unspecified if ongoing), notes: There was not other history of headache other than short lived course tension headaches during 2015; "headache", start date: 2015 (unspecified if ongoing), notes: There was not other history of headache other than short lived course tension headaches during 2015. Concomitant medication(s) included: OMEPRAZOLE; ATOMOXETINE. The following information was reported: HEADACHE (non-serious) with onset 19Dec2020, outcome "recovered with sequelae", described as "severe headache"; HEADACHE (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 19Dec2020, outcome "recovered with sequelae" and all described as ""ice-pick", sharp stabbing headaches that come out of no where". The events "severe headache", ""ice-pick", sharp stabbing headaches that come out of no where" and ""ice-pick", sharp stabbing headaches that come out of no where" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of headache, headache, condition aggravated.  Additional information: It was reported that, patient had severe headache for 3 days after initial vaccination that NSAIDS could not relieve and for 1 day after second vaccination. The more concerning side effect though was ice-pick, sharp stabbing headaches that come out of nowhere and last for seconds to several hours for the past year. They typically happen multiple times a week (3-5x). These have not resolved as of (4Mar2022) and often NSAIDs were little to no help. There was not other history of headaches other than a short lived course of tension headaches during 2015. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No known allergies.  Follow-up attempts completed. No further information is expected.
This spontaneous report was received from a medical assistant, referring to an unspecified number of patients of unknown gender and age. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On unknown dates in 2017, from 24-APR-2017 to 09-MAY-2017, the patients were vaccinated with improperly stored doses of ROTATEQ with lot # M040267 and expiration date of 14-MAY-2018 (orally; strength and dose were not reported) for prophylaxis, however no adverse effects were reported. It was reported that the vaccine was exposed to a temperature of 47 Fahrenheit degrees to 77 Fahrenheit degrees range for a time frame of 28 minutes. The temperature excursion was recorded by a data logger and it had previous temperature excursions on 19-APR-2017 of 32 Fahrenheit degrees to 35 Fahrenheit degrees for 29 minutes. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA009720: US-009507513-1705USA005357:
Pt woke up day after vaccine administered with left arm area swollen. Pt had received pneumonia & flu vaccines in past with no problems. Advised pt to use heat/cold to area, pain reliever & diphenhydramine & to call MD/ER if tongue/lips swell or difficulty breathing.
No side effects from first dose of vaccine. Many side effects from second dose. Once second dose was administered, arm immediately became sore. This progressively got worse during the day, including a hard lump and was itchy. Approx. 6 hours later, I became fatigued and had body aches all over. At 30 hours post second vaccine, I started to run a temperature. It got up to 101.5 F, I took Tylenol and went to sleep. By the morning, it was gone. The next 2 days, I had a headache and very sore arm. On day 3 I developed a very sore armpit/under arm area on the same arm as I received the vaccine. As I'm writing this (4 days later), my arm is still sore & itchy and my underarm area is still sore, but no fatigue or fever.