chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lip blister/sores; itchy arm; swollen lymph nodes; red arm rash; headache; tiredness; fever; not feeling right; feeling cold; diarrhea; scratchy, itchy and tickle in throat; loss of appetite; ear infection on and off; cough; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling right) and FEELING COLD (feeling cold) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 012L20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LOSARTAN, FLECAINIDE, ROPINIROLE HYDROCHLORIDE (REQUIP), FUROSEMIDE (LASIX [FUROSEMIDE]), APIXABAN (ELIQUIS), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and PARACETAMOL (TYLENOL) for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 16-Feb-2021, the patient experienced MALAISE (not feeling right) and FEELING COLD (feeling cold). On 18-Feb-2021, MALAISE (not feeling right) outcome was unknown and FEELING COLD (feeling cold) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, Pyrexia: 100.4 (Inconclusive) fever of 100.4F.    Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: NNI case.
Patient reports feeling like body is on fire, chills, and weakness. Terrible headache. No swelling or redness at injection site but does have a little pain. Patient advised to come into office today.
Patient developed swollen area around site of injection. It covers most of his lower half on the back of his upper arm. The patient states it is itchy and a little painful. I recommended hydrocortisone cream and BENADRYL.
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Concomitant medication and current conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of VARIVAX (Merck) Lot number J012375 and expiration date 03-OCT-2015 (dose and route were not reported). Concomitant medication was not provided. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
enlarged lymph node on the left side of the neck, CAUSED FALSE POSITIVE IN NECK LYMPH NODE REQUIRING BIOSPY; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (enlarged lymph node on the left side of the neck, CAUSED FALSE POSITIVE IN NECK LYMPH NODE REQUIRING BIOSPY) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 031A21A) for COVID-19 vaccination.     The patient's past medical history included Hysterectomy on 28-May-2021. Concurrent medical conditions included Pre-diabetes since 01-Jan-2012 and Hypothyroidism since 01-Jan-2011.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced LYMPHADENOPATHY (enlarged lymph node on the left side of the neck, CAUSED FALSE POSITIVE IN NECK LYMPH NODE REQUIRING BIOSPY). On 03-Jul-2021, LYMPHADENOPATHY (enlarged lymph node on the left side of the neck, CAUSED FALSE POSITIVE IN NECK LYMPH NODE REQUIRING BIOSPY) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2021, Positron emission tomogram: abnormal (abnormal) saw an enlarged lymph node on the left side of the neck.. On 29-Jun-2021, Biopsy: abnormal (abnormal) positive biopsy in the uterus.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported.  It was reported that, in April/May patient was given a PET scan where they found enlarged lymph node in neck (left side), same side as the shots were given. In Jun, then the patient had to under go a needle biopsy in order to rule out cancer. The biopsy came back negative. The patient's oncologist agreed that this was caused by the Covid shot.   No treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Significant FU. medical history added.Event information updated. outcome of event recovered/resolved added.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL SULFATE] taken for asthma. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: anti viral details [product=COVID 19 Treatment, brand=Paxlovid, treatment start date=03Jun2022, treatment stop date=08Jun2022, indication=Treatment of COVID-19]  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
6 days after receiving the first dose of Pfizer Covid-19 vaccine, he developed severe disequilibrium to the point that he had severe difficulty sitting up and ambulating.   The disequilibrium was severe for twelve days but then seemed to be largely resolved.  The second Pfizer Covid -19  vaccine was received on 02/06/2021  (lot EN5318) and  the severe disequilibrium began again February 12.   complete evaluation with CT head, abdomen and pelvis, chest X-ray, lab , EKG and echocardiogram showed no explanation for symptoms.  The second round of severe disequilibrium resolved by February 25.
Rapid heartrate Itching throughout limbs Starting a few days after: pudendal nerve pain becoming severe after second shot Shooting pain, burning, numbness in pelvis and left leg  Acute itch on bottom of left foot Moderate burning while sitting (still feeling this) It gets better when I stand or lie down
This case was reported by a medical assistant and described the occurrence of seizure in a 2 day old male subject who was vaccinated with hepatitis B vaccine recombinant (Engerix B) for prophylaxis. On Jan 17 2002, the subject received 1st dose of Engerix B (lot ENG5252A2). At an unspecified time after vaccination with Engerix B, on or after 01/17/2002 an don or before May 4 2005, the subject experienced seizure. The outcome of the seizure was not reported. Comment: seizure was assessed as medically serious by manufacturer (OMIC).
-LIMP ARM WITHIN 30 MINUTES OF VACCINATION -LEFT ARM, NECK, AND FACE SWELLING WITHING AN HOUR OF RECEIVING VACCINE - LASTED FOR 6 DAYS -UNABLE TO MOVE LEFT ARM, RAISE IT, OR LIFT ANYTHING FOR THE PAST 18 DAYS -UNABLE TO GRASP OBJECTS WITH LEFT ARM FOR THE PAST 18 DAYS -UNABLE TO SLEEP ON LEFT SIDE - CAUSES EXTREME PAIN -TINGLING AND NERVE SHOOTING PAIN ON LEFT ARM FROM FINGERS TO NECK, FRONT AND BACK CHEST LEFT SIDE -MUSCULAR NODULE DEVELOPED ON LEFT SHOULDER UP TO MY KNECK - CAUSING SEVERE EAR PAIN -EXTREME FATIGUE - LETHARGIC FOR THE PAST 18 DAYS -SEVERE JOINT/PAINT THROUGH OUT ENTIRE BODY -LOST OF TASTE -NIGHTSWEATS FOR PAST 18 DAYS -FEVERS RANGING BETWEEN 99.0 - 103 F FOR PAST 18 DAYS -NAUSE FOR PAST 18 DAYS -LOST OF APPETITE -DIARRHEA AND LOOSE STOOLS FOR THE PAST 8 DAYS (NO BLOOD) -BRAIN FEELS FOGGY ALL THE TIME - FEELING AS IN A DAZE FOR PAST 18 DAYS -SHORTNESS OF BREATH - JUST FROM WALKING OR MOVING AROUND -SKIN IS SUPER SENSITIVE AND ITCHY -UNABLE TO DRIVE BECAUSE OF THE FATIGUE AND UNABLE TO USE LEFT ARM.  -UNABLE TO WORK - RELYING ON OTHERS TO TAKE CARE OF ME.
On May 30, 2022 I had a bad cough and tight chest. I did an at home Covid test that was negative. On May 31st it felt like a minor chest cold and still had a bad cough and tight chest. On June 3 I went to an urgent care and was given PAXLOVID. After 24 hours on PAXLOVID I started to notice my symptoms going away. I have not had any symptoms since then.
This infant began vomiting 18 hours after her immunization. She was taken to the doctor, stated possibly due to the shots. The mother called the doctor on 01/30/01 with complaints of continued vomiting. The doctor said now it's probably not due to the vaccines and watch child with next vaccines. No temp, no rash. Diarrhea started 01/31/01.
Associate broke out in an itchy, red bumpy rash on neck and bilateral arms a couple of hours post vaccine.
Arm swollen, red all the way down to elbow, lymph nodes under arms swollen, all symptoms started on 1/4,
Lump on her left shoulder; This is a spontaneous report from a contactable consumer(patient).   A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot: EL9261) on 21Jan2021 at single dose in the left arm for COVID-19 immunization.  Medical history was none.  There were no concomitant medications.  Patient got her first dose of vaccine on 21Jan2021. She woke up on 27Jan2021 with a lump on her left shoulder. Her doctor said to inform the center where she got the vaccine, this may be related to the vaccine. Patient stated she was not sure if it was related. She said she was so nervous hopefully it was nothing. The final outcome of the event was reported as not recovered. Patient is supposed to get her second vaccination between 07Feb2021-11Feb2021.
Severe pain in the left arm that goes up to my shoulder and neck.  Minimal motion on my left arm and pulsating pain that  interferes with me doing my job as a senior fitness coach and can't get a good night's sleep.
On 2/18/21, her arm felt itchy, got up and went and looked in the mirror and her arm was red and swollen.  She rubbed the area and the reaction was below the injection site (1/4" below).  It runs down the arm 3" from the injection toward her elbow, and width is 5".  It is not as puffy as it was, somewhat paler, but very obvious and noticeable.  It is not itching as bad, and is putting wet washcloths on it for relief.  The size of it is still the same size and has not changed, possibly spread a little.   She called her doctor who told her to take Tylenol and put the cool rags on it.
No additional AE; a patient was inadvertently administered VARIVAX via intramuscular rout rather than subcutaneously; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, and allergies were not reported. Concomitant medications included sterile diluent.    On 17-OCT-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) administered intramuscularly (lot #W012166 had been verified to be a valid number; expiration date 12-APR-2024 and upon internal validation established as the same date) (dose, vaccination scheme, frequency, and anatomical site of injection were not reported) (incorrect route of product administration). No additional adverse events were reported.
From initial information received on June 27 2005 from a health care professional regarding an adverse event, it was reported that a 19 year old male patient received a dose of Menactra vaccine, lot number U1589AA, administered at 4:00pm on June 22 2005. Reportedly ten minutes later the patient became lightheaded and felt faint. It was not reported if the patient needed any treatment. Reportedly the patient recovered from these events. The reporter of this case is the same reporter of cases: 200501235, 200501236, 200501237, 200501239 and 200501240.
Tachycardia (160 to 180 beats per minute), shortness of breath, lightheadedness.  Onset 2.5 hours after vaccine.  Treated with diltiazem CR 120 mg.  Resolved 6 hours after onset.
11/06/2001 0.5cc Pneumococcal vaccine Polyvalent 23 given IM left deltoid at 12:10. Received telephone call at 3:55pm. Pt reports arm is red, swollen and warm to touch. Advised to call MD for exam. Pt to provider (of vaccine) office at 4:05 pm. Left arm swollen, red, warm to touch, edematous inflamed from left elbow to shoulder (around injection site). Pt was treated with Zyrtec and sent home. No further complaints reported. Received Influenza vaccine 0.5cc IM to Right arm with no reaction.
12/03/2003: Mom reports red bump at Prevnar site right arm.  12/15/2003: Redness gone, able to palpate bump-size 0.5mm.  Did not cause discomfort with palpation.
Patient reports feeling lightheaded, felt he was going to pass out, feeling tired, no dizziness. Patient was assessed by EMs,  patient reports symptoms improved, he was feeling better, cleared by EMS. BP 161/83, pulse 72, Spo2 98%
Arthritis flare up after the first dose. Extreme fatigue, sleepiness, lack of appetite, extreme joint pain after the second dose.
Sore arm; Itchy rash on back; Swelling; Red blotches all over her arm; Fever; Worsening rheumatoid arthritis; Worsening fibromyalgia; Flu like symptoms; A spontaneous report (United States) was received from a consumer concerning herself, a 74-year-old, female patient who Moderna's COVID-19 Vaccine (mRNA-1273) and experienced worsening fibromyalgia, worsening rheumatoid arthritis, flu-like symptoms, sore arm, itchy rash on back, fever, swelling and red blotches all over her arm.  The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.     On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011L20A). On 05 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number:031L20A) intramuscularly in the arm for prophylaxis of COVID-19 infection.    On 06 Jan 2021, after the first shot of vaccine, the patient experienced worsening fibromyalgia, worsening rheumatoid arthritis like her fingers were hurting so bad that she felt like they were going to fall off and flu like symptoms with fever. On 05 Feb 2021, after the second shot, patient experienced sore arm, swelling, red blotches all over her arm and itchy rash on her back. Treatment for event included acetaminophen and diphenhydramine which didn't seems to help events at all.  Action taken with mRNA-1273 in response to the events were unknown.  The outcome of the events, worsening fibromyalgia, worsening rheumatoid arthritis, flu-like symptoms, sore arm, itchy rash on back, fever, swelling and red blotches all over her arm were considered unknown at the time of this report.; Reporter's Comments: Based on the current available information, a temporal association between the use of the product and the onset of the reported events, and the known safety profile of mRNA-1273 a causal relationship cannot be excluded
I received the vaccine on 06/06/21 and the following morning I had numbness and tingling in both hands and both feet.   I saw my primary care doctor on 6/16/21 to follow up on my symptoms.  She referred me to a neurologist.  The neurologist would not advise me whether to get the second vaccine dose.  I decided to get the 2nd dose on 7/8/21, and the following morning I had numbness and tingling in both hand and both feet, and it was much worse than after the first dose.
Information has been received from a certified medical assistant concerning an 8-year-old male with no pertinent medical history or drug allergies who on 19-JAN-2001 was vaccinated subcutaneously in the left arm with a dose of varicella virus vaccine live (Oka/Merck) (lot# 635191/0939K). Concomitant therapy included measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (manufacturer unknown) and tuberculin purified protein derivative (manufacturer unknown). On 20-DEC-2007 the patient experienced chickenpox. The patient was examined in the office on 22-DEC-2007 and there were 8 to 10 papules that were itchy on the face, chest and arms. The patient did not have a fever. No laboratory or diagnostic tests were performed. The outcome was reported as recovering. No product quality complaint was involved. Follow up information has been received concerning a white male who received a subcutaneous dose in the right arm of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (lot# 635281/0405K) on 19-Jan-2001. There was no illness at the time of vaccination. On 20-DEC-2007 the patient had 8-10 papule vesicular lesions on the face, chest and arms. On an unspecified date, the patient recovered and is done care. Additional information is not expected.
Pt reported few days of flu-like symptoms, sweating, headache, fever, chills, unable to stand up. Also body aches x 24 hours. Did not seek medical attention at the time.
Pt likely GERD flare up s/p MENACTRA vax - increased hiccuping, inc. abd pain - recurrent GERD sx.
For both the first and second dose there was an immediate response, within the first 30 seconds. My wife describes it as a "heavy limb" feeling. Legs and arms felt heavy, difficult to lift them. She felt her heart was racing (didn't feel like it from the pulse). For the second dose we specifically went to an urgent care facility where she could lie down as the first time at a pharmacy was very uncomfortable. After perhaps 20 to 30 minutes this response faded enough to be able to leave the facility though she still experienced some of the effect into the following hours. By the evening she was mostly better. Following the second dose, this morning she has chills and a low-grade fever (99.8°) and considerable body aches. Significant arm pain after both doses.
achy after first dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (achy after first dose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (NOS) (Stage IV cancer in remission.) and Walking difficulty. Concomitant products included PALBOCICLIB (IBRANCE) and LETROZOLE for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced MYALGIA (achy after first dose). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, MYALGIA (achy after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment activities for event was also done with Anti-viral medication.   This case was linked to MOD-2021-107109 (Patient Link).
Received extra (4th) dose of Rotateq and 4th dose of DTaP given too early. No adverse symptoms noted. Parents communicated desire for event to be reported.
On 1/30/2007 pt had fever of 99 and a few lesions: 1 lesion with an erythematous base, not quite a clear blister, but there was a papule, and she had some scattered erythematous fine papules in the diaper area.   Pt is a twin and her twin sister had a similiar reaction. Form submitted separately.
Narrative:  Sxs are still present. Advised it may be SIRVA- shoulder injury related to vaccine administration.
Sick (Kidney Problems); This spontaneous case was reported by a consumer and describes the occurrence of RENAL DISORDER (Sick (Kidney Problems)) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Kidney disorder (kidney problems (no dialysis)).    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced RENAL DISORDER (Sick (Kidney Problems)) (seriousness criterion hospitalization). At the time of the report, RENAL DISORDER (Sick (Kidney Problems)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       About two weeks after vaccination the patient became sick  and was hospitalized. The patient was sent to a  convalescent home from the hospital and then back to the hospital for 2 months then back to the convalescent home again. The patient had spent March, April and May 2021 in those facilities. On 27-May-2021, the patient came back home.  No concomitant medications and treatment information reported.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of these event, a causal relationship cannot be excluded. However, the previous history of Kidney disorder is a confounder.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these event, a causal relationship cannot be excluded. However, the previous history of Kidney disorder is a confounder.
pt stated that she started feeling bad and vomited.  She noticed a lump under her left armpit.  She stated she had a mammogram a little over a month ago and she did not have any lumps under her armpit at that time.  Pt will contact her PCP to make them aware of her symptoms but there are getting better at this time.
App. 20 min. after receiving vaccine, pt. c/o burning chest pain w/difficulty breathing.  V/S: 148/96 R-20 P-82, clear breath sounds and auscultation arteriorly and posteriorly, no rash, c/o tingling to both hands.  Had pt. breathe in paper bag with no relief.  Client stated CP too bad to ambulate, EMS called & pt. transported to local hospital. Pt. released same day from ER, DX: pleurisy.
Cough, sore throat, swollen glands, weakness, tiredness After about two weeks the symptoms lessoned substantially. I was given a Covid-19 test and a strep test. Both were negative. The PA prescribed lots of liquids and lots of rest.. That is what I have been doing and the symptoms have gradually lessened.
p/vax pt exp general urticaria. seen by MD in ofc & treated w/benadryl & aveeno bath.