chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site arm was hot to the touch; Injection site arm was hard; Injection site arm became red; Injection site arm was swollen; Nausea; Chills; No appetite; Dizziness; Fever of 103°F; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site arm was hot to the touch), DECREASED APPETITE (No appetite), DIZZINESS (Dizziness), VACCINATION SITE INDURATION (Injection site arm was hard) and PYREXIA (Fever of 103°F) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder. Concomitant products included PREDNISONE for Autoimmune disorder NOS.   On 28-Feb-2021, 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) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced PYREXIA (Fever of 103°F). On 01-Mar-2021, the patient experienced DECREASED APPETITE (No appetite), DIZZINESS (Dizziness), NAUSEA (Nausea) and CHILLS (Chills). On 03-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Injection site arm was hot to the touch), VACCINATION SITE INDURATION (Injection site arm was hard), VACCINATION SITE ERYTHEMA (Injection site arm became red) and VACCINATION SITE SWELLING (Injection site arm was swollen). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Injection site arm was hot to the touch), DECREASED APPETITE (No appetite), DIZZINESS (Dizziness), VACCINATION SITE INDURATION (Injection site arm was hard), PYREXIA (Fever of 103°F), NAUSEA (Nausea), CHILLS (Chills), VACCINATION SITE ERYTHEMA (Injection site arm became red) and VACCINATION SITE SWELLING (Injection site arm was swollen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Feb-2021, Body temperature: 103 (High) 103 degree fahrenheit. On 02-Mar-2021, Body temperature: 100 (High) 100 degree fahrenheit. On 03-Mar-2021, Body temperature: 102 (High) 102 degree fahrenheit. On 04-Mar-2021, Body temperature: 99.5 (Inconclusive) 99.5 degree fahrenheit.         patient also used cold compresses as treatment. Action taken with mRNA-1273 in response to the events was not applicable.
This spontaneous report as received from a nurse via field representative refers to a 3 year old female patient mentioned as healthy young lady, immunocompetent, with no health issues. The patient is the grandchild of the nurse. On 02-JAN-2012, the patient was vaccinated with VARIVAX (Merck) dose 1 at the physician's office. Dose and route were not reported. Lot number was 671126/1062AA and expiry date 05-JUL-2013. From an unknown date in November 2013 approximately (reported as currently), the patient was being treated for chicken pox diagnosed on 19-NOV-2013 (reported in followup call as yesterday), and at doctor's appointment on 20-NOV-2013 (reported as today in follow up call). The pox had started to blister. The outcome of chicken pox was not resolved. The child's physician's contact information was provided, but not mentioned if medical attention was sought. Nurse stated that she thought it was unique that both children had chicken pox reported one day apart that were administered in January 2012, in different facilities. Both children had small, multiples of chicken pox. No treatment was prescribed. This is 2 of 2 reports from the same reporter. Additional information has been requested.
Red bumps o inner aspect of left wrist and lower arm. Next morning lump on inner aspect of upper left arm. Telephone call to doctor, called out Cipro. Took it ID: stopped N+V/ Diarrhea: pain in arm. Telephone call to Doctor:"resume Cipro". To ER on 10/02/2004. "allergic reaction to pneumo vaccine.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline).  In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown).  In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint.  The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site.  At the time of reporting the outcome of the events were unspecified.  For the other 79 linked subjects please see cases : A0756483A - A0756491A, A0756493A - A0756562A.  The agency provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in Safety stated AFLUA3508A.  With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA).  On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA) : AFLUCA320, AFLUA320A, and AFLUA320B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA.  On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA) : AFLUCA350 and AFLUA350B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
local rxn rt leg-redness-hardness in center about size of quarter-was @ ER last noc; no fever-given Amoxil per MD; hot compresses q 4 hr x 24 hr;
After flu shot patient had jaw soreness/tenderness that evening on right side. Received shot in right arm.
Fever 102.6 Chills Moderate pain at injection site  Severe headache Body ache  Hot/cold flashes Severe fatigue Began around 10pm day of vaccine. Symptoms became more severe for next 24 hours then began to dissipate. Fever broke at 24 hours.  Still showing severe and mild arm pain at injection site
The vaccine was given on Friday and on the next Tuesday evening she experienced excruciating pain in her joints, knees, arms and elbows. She developed difficulty walking without pain or holding on to something. She also experienced dizziness and headache with balance issues.
Bilateral red eyes mild cough headache all transient, lasting until about 7:00AM the next morning
Muscle aches/pain, chills, headache, fatigue, fever, nausea, injection site pain
This spontaneous report was received from a registered nurse and refers to multiple patients of unspecified age and gender. No information regarding the patients' medical history, concurrent conditions, drug reactions or allergies was reported. On an unspecified dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # K010216, expiration date: 17-SEP-2016, and lot# K02144, expiration date: 17-SEP-2016; dose, route of administration and anatomical location were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
11 days p/vax pt became fussy & devel a rash. 24mar MD characterized rash as ``12 blanchable, slightly indurated, pink papular lesions
Headache; nausea; This is a spontaneous report from a contactable other health professional (other HCP) (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) via an unspecified route of administration at right arm on 21Dec2020 at 10:00 a.m. at a single dose (dose number: 1) for COVID-19 immunization. Medical history included hypothyroid and hyperlipidemia. Concomitant medications in two weeks included levothyroxine, simvastatin (ZOCOR), ergocalciferol (VITAMIN D), ascorbic acid (VITAMIN C) and calcium (reported as calcium mul, to be clarified). No other vaccine in four weeks. The patient was not pregnant. Facility type vaccine was hospital. No COVID-19 diagnosed prior vaccination and no COVID-19 tested post vaccination. No known allergies (no allergies to medications, food, or other products).  The patient experienced headache, nausea on 22Dec2020 at 12:00 p.m. with outcome of resolved in Dec2020. The events were reported as non-serious. No treatment received for events.
Rapid heartbeat; Short breath; Heart was pounding; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heartbeat), DYSPNOEA (Short breath) and PALPITATIONS (Heart was pounding) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced HEART RATE INCREASED (Rapid heartbeat), DYSPNOEA (Short breath) and PALPITATIONS (Heart was pounding). At the time of the report, HEART RATE INCREASED (Rapid heartbeat), DYSPNOEA (Short breath) and PALPITATIONS (Heart was pounding) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Feb-2021, Heart rate: 99 (Inconclusive) 99 beats sustained for 12 hours.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
TDap left upper extremity; Severe local reaction: (swelling, erythema, induration 6-8cm; mild systemic reaction: mild fever
A 48 YO was given the 1st dose of Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 48-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th May 2020, the patient received the 1st dose of Shingrix. On 6th May 2020, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were reported as follows: The patient received Shingrix at the age of 48 year, which led to inappropriate age at vaccine administration. No additional details reported.
Three days after the first dose of the Moderna COVID 19 Vaccination I experienced chest pain with tingling/numbness in fingers and arms. Still currently experiencing symptoms.
4 and 1/2 half hours after injection, both hands started to itch and turned beet red from finger tips to wrists. I called pharmacy and they said ok to taking Benadryl.  I took 2 and 1/2 hour later the itching and redness went away.
IZ received @ 3:30pm 4/25/01. C/O fever 99.9F @ 6pm 4/25/01, took regular strength tylenol 2 tabs po x 1 dose. Fever gone at 2pm 4/26/01. When pt woke up at 5am 4/26/01 he c/o dizziness and wheezing. Took 1 dose benadryl (otc) at 5:30am and slept. Denied problems @ present 1:30pm 4/26/01.
High temperature, General pain. Patient said could not stand upright because of pain. General feeling of un-wellness and fatigue.
Anaphylactic Shock; Flu; Difficulty in breathing; Difficulty in swallowing; Body aches; Fatigue / Tiredness; Itching; redness in the injection site; Swollen throat; This case was reported by a nurse via sales rep and described the occurrence of anaphylactic shock in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number ZH79H, expiry date 28th March 2022) for prophylaxis.   On 13th December 2019, the patient received the 1st dose of Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced anaphylactic shock (serious criteria GSK medically significant), influenza, difficulty breathing, swallowing difficult, general body pain, fatigue, pruritus, injection site erythema and throat swelling. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the anaphylactic shock, influenza, difficulty breathing, swallowing difficult, general body pain, fatigue, pruritus, injection site erythema and throat swelling were unknown.   It was unknown if the reporter considered the anaphylactic shock, influenza, difficulty breathing, swallowing difficult, general body pain, fatigue, pruritus, injection site erythema and throat swelling to be related to Shingrix.  Additional details were provided as follows: The patient experienced anaphylactic shock, flu, difficulty in breathing, difficulty in swallowing, body aches, fatigue, tiredness, itching and redness in the injection site. The patient went to the emergency department and was given Benadryl and later discharged home The reporter consented to follow up. The batch number was changed from CH79H to ZH79H as per sales data sheet.
It was reported to writer that patient was vomiting in aftercare.  This was reported at 4:50 pm by the school which was approximately 2 hours and 50 minutes after patient finished in observation.
Patient entered the covid 19 vaccination clinic stating that they needed their bi-valent booster. Both vaccines were administered. After administration and documention, employee noticed they had already been vaccinated 2+ months ago with the bi-valent. Patient departed the premises prior to being aware of error. Patient did not appear to have any adverse reactions to doses prior to leaving the facility. Attempted to notify patients, but there was no answer.
p/vax pt collapsed w/eyes rolling up; initial HR-60/min w/BP 85/50; very pale; weak slow pulse; but coherent; tx: epinephrine subcutaneous & HR gradually returned to nl in 1/2 hour
p/pt recv vax devel severe red rashes around entire upper arm of inj site; dependent edema extending from the pt elbow to the wrist; treated w/benadryl & recovered within 48hr
Within one hour of receiving flu vaccine, experienced sudden onset of shortness of breath, throat tightness and severe coughing. Took 25mg. Benadryl which decreased shortness of breath and throat tightness. Has mild cough.
left upper arm reddened, edematous, firm, hot-to-touch from ~1" above elbow lateral, posterior, & anterior aspects extends to anterior a/c joint (shoulder area).  Child afebrile. Tx: (per private physician) zithromax, atarax, motrin, ice; to follow-up 8/2/02
Extensive erythematous maculopapular rash on back and chest, with associated itching
She had chest pain; She felt like she was filling up with fluids; She felt like she had pneumonia; She has been suffering from memory loss right after the fever issues; She had body aches; She had trouble breathing; She felt like she wanted to sleep; She was sweating and shivering at the same time; She had body racking chills within 24 hours of receiving 2nd dose; After 2nd dose, she had 102 fever that started within 24 hours and lasted for 5 days.; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (She had trouble breathing), SOMNOLENCE (She felt like she wanted to sleep), HYPERHIDROSIS (She was sweating and shivering at the same time), CHEST PAIN (She had chest pain) and FLUID OVERLOAD (She felt like she was filling up with fluids) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GABAPENTIN, METOPROLOL, LOSARTAN, FLUOXETINE and ATORVASTATIN for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced HYPERHIDROSIS (She was sweating and shivering at the same time), CHILLS (She had body racking chills within 24 hours of receiving 2nd dose) and PYREXIA (After 2nd dose, she had 102 fever that started within 24 hours and lasted for 5 days.). On an unknown date, the patient experienced DYSPNOEA (She had trouble breathing), SOMNOLENCE (She felt like she wanted to sleep), CHEST PAIN (She had chest pain), FLUID OVERLOAD (She felt like she was filling up with fluids), PLEURAL DISORDER (She felt like she had pneumonia), AMNESIA (She has been suffering from memory loss right after the fever issues) and MYALGIA (She had body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. On 03-May-2021, PYREXIA (After 2nd dose, she had 102 fever that started within 24 hours and lasted for 5 days.) outcome was unknown. At the time of the report, DYSPNOEA (She had trouble breathing), SOMNOLENCE (She felt like she wanted to sleep), HYPERHIDROSIS (She was sweating and shivering at the same time), CHEST PAIN (She had chest pain), FLUID OVERLOAD (She felt like she was filling up with fluids), PLEURAL DISORDER (She felt like she had pneumonia), AMNESIA (She has been suffering from memory loss right after the fever issues), MYALGIA (She had body aches) and CHILLS (She had body racking chills within 24 hours of receiving 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Body temperature: 102 (High) body temperature.
Low grade fever, Body aches, Nausea, Dizziness, weakness, lethargic.
Patient's arm was swollen by phone message. Patient was not seen. Left arm  got swollen.
After the first vaccine, my arm stayed swollen for two weeks. Approximately two weeks after, I developed a red rash at the injection site that was about 6 inches in diameter. This disappeared after about 4-5 days. After the second vaccination, I developed very high fever reaching its highest 103.9°F. In addition, I experienced significant flu like symptoms including, body aches, headache, joint pain, chills, nausea. I did throw up and dry heave the night of the injection. I continue with all of these symptoms now more than 24 hours later. If I have not recovered by Monday, I will go to my physician.
Flu shot area swelled to size of silver dollar pain went under arm to opposite side and down toward breast. Could not use left arm.
pt recvd vax; inadvertently given Pnu-immune intradermally instead of PPD mantoux;exp burning & itching immed p/ adm;large area of redness; tender to touch w/in 24 hrs; antihistamine;
Burning sensation at injection site within 30 seconds, itchy throat started within 2-3 min. Then swelling of throat and eyes within 5-10 minutes. Swelling in eyes continued through today.
Crushing headache, general malaise, disturbing heart palpitations and skipping of heartbeat, neck pain, Chest pressure
THE PATIENT CALLED COMPLAINING OF LEFT ARM PAIN WITH REDNESS AND SWELLING. SHE THINKS THAT THIS IS MAYBE BECAUSE THE SHOT MAY HAVE BEEN GIVEN TOO LOW ON HER LEFT SHOULDER AND MAYBE NOT DEEP ENOUGH. I TOLD HER TO CHECK WITH HER PROVIDER IF HER ARM IS NOT BETTER IN A FEW DAYS WITH SELF CARE.
Initial itch at dosing; fine for six days; On day 7 noticed 2" vertical and 3/4" at widest width a deeply pink bright "shot-glow" shaped area at dose site but not itchy or painful. Removing sweater made site less pink as el cooled off to change for night time. On day 8, felt momentary itch at site followed by quick flash of HOT pain at site-then nothing ever again at site, but pink noticeable shot flow shaped area took weeks to fade. It is still evident (no big deal) but I hope it goes away over time. (I had chicken pox as a toddler).
I had a swollen lymph node in left arm pit. I went to the doctor and she stated she has seen it a look in other patients that have received the vaccine. No treatment was given, I am still in pain but not as constant as when I first got it.
Patient is fully vaccinated.  Tested + for COVID 1/4/2022.  Hospialized for GI bleed on 1/2/2022.63-year-old male who woke up with abdominal pain yesterday morning and had an episode of black diarrhea.  He stated that he has had 5 episodes of black diarrhea and 3 episodes of black hematemesis as well prior to arriving to the hospital. His hemoglobin and hematocrit on December 20 was 14.8/14.5.  On this admission, his hemoglobin and hematocrit was found to be 10.9/31.8, a 4 g drop in less than 2 weeks.He was given 2 units of PRBCs, and was evaluated by gastroenterology. he was deemed stable for discharge home, and was counseled to follow-up with GI outpatient in the next 1-2 weeks.
elevated heart rate; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (elevated heart rate) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039k20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 08-Jan-2021, the patient experienced HEART RATE INCREASED (elevated heart rate). At the time of the report, HEART RATE INCREASED (elevated heart rate) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Heart rate: high (Inconclusive) elevated heart rate..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided Symptoms have come and gone reappearing on Jan 17th and Jan 22nd. No Treatment information provided
This spontaneous report was received from a pharmacist, concerning an adult patient of an unknown gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On an unknown date, the patient, that was older than 26 year-old, was vaccinated with GARDASIL 9 injection (dose, frequency, route of administration, lot number and expiration date were not reported) for an unknown indication. No adverse effects were reported. Additional information is not expected, as no consent to contact the reporter was granted.
shingles; Initial information regarding an unsolicited valid non-serious social media case was received from a non-healthcare professional (consumer) on 07-Dec-2020.  This case involves Adult patient who experienced shingles (Herpes zoster), while he/she received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  The patient developed a non-serious shingles (herpes zoster) (unknown latency)  following the administration of INFLUENZA VACCINE.  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown.  There will be no information available on the batch number for this case.