chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore left arm; Shaking; Very tired; 99F without high fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm), TREMOR (Shaking), FATIGUE (Very tired), PYREXIA (99F without high fever) and CHILLS (Chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced PAIN IN EXTREMITY (Sore left arm), TREMOR (Shaking), FATIGUE (Very tired), PYREXIA (99F without high fever) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Sore left arm), TREMOR (Shaking), FATIGUE (Very tired), PYREXIA (99F without high fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Nov-2021, Body temperature: 99 (normal) no high fever just 99F.         No treatment details provided. No concomitant medications reported.   This case was linked to MOD-2021-374891, MOD-2021-374892 (Patient Link).
Cold and cough; Cold and cough; She developed a rash, and it has progressed to different places on her body. He states it is now on her legs, knees, arms, and hand.; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (husband).  A 78-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: ER2613) via an unspecified route of administration, in arm left on 19Apr2021 at 11:30 as dose 1, single (age at vaccination 78 years) for covid-19 immunisation. Medical history included ongoing high blood pressure, was diagnosed 35 years ago; ongoing hypothyroidism was diagnosed 35 years ago, ongoing bloating around midsection, she was allergic to eggs, so flu shots made her sicker than dogs, the patient was in a wheel chair and the reporter had to get her around in that. The patient previously took sulfa drugs and had allergic reaction. The patient took Armor for a real long time for hypothyroidism. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for hypothyroidism within the past year since an unknown date, orally; atenolol taken for high blood pressure since an unknown date and ongoing; furosemide taken orally for bloating around her midsection since an unknown date and ongoing. On an 26Apr2021 the patient experienced Cold and cough, She developed a rash, and it has progressed to different places on her body. He states it is now on her legs, knees, arms, and hand. The patient experienced rashes after getting first dose. It was reported that a week later from getting the vaccine she developed a rash, and it had progressed to different places on her body. The reporter stated it was now on her legs, knees, arms, and hand. He stated that it originally just showed up on the side of her elbow but then progressively started spreading all over. He stated that it had not gone to her face yet. He stated that wife had a cold and she was coughing and he was having a hard time hearing over her. He stated that it was an allergy cold and she got them every other month. It started 26Apr2021 and was still ongoing and persisting. There was no history of previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of the Pfizer suspect. Patient scheduled for the second dose 13May2021. The events did not require a visit to emergency room or physician office. The prior vaccinations (within 4 weeks) were not reported. The patient's family medical history relevant to events was not reported. There were no relevant tests. The outcome of the events was not recovered.  Description of complaint:  Furosemide: The reporter stated the patient was bloated around the midsection and the doctor can't get the excesses water out of her. He stated that it was very uncomfortable for her. He also stated that she was allergic to eggs, so flu shots made her sicker than dogs.  No follow-up attempts are needed. No further information is expected.
Onset of soreness at injection site w/i 24 hrs. Soreness continued, then worsened over period of 10 wks. Firm movement restrictions began approximately 10/16 and got progressively worse through late November. Frozen shoulder diagnosed 11-21-14. Manipulation under anesthesia performed 12/10/14; P.T. continues through 1-6-15.
pt recv vax 5AUG98 & lightheaded;taken to ER because was confused;had x-rays of head & neck & CAT scan negative;lab work nl x/dec calcium referred to neuro;unable to drive;pt did not eat that day;
This is a spontaneous report from a contactable pharmacist reporting for her husband. A 41-year-old male patient received PREVNAR 13, probably intramuscular in right upper arm at 0.5 ml single. Medical history included spleen operation (removal). Concomitant medications were none. The pharmacist reported that approximately three weeks after receiving PREVNAR 13, the patient (her husband) complained that his white blood cell count was 4.5 and his neutrophils count was 29.1. The patient experienced low white blood cell 4.5, neutrophils down to 29.1 and lymphocytes 56.6 on 29Jan2016. No therapeutic measures were taken as a result of the events. It was recommended to repeat blood test later. Additionally the patient complained that the arm, where he received the injection of PREVNAR 13, was sore for several days. The outcome of the events was unknown. The pharmacist didn't know if low white blood count was related to PREVNAR 13. Follow-up (29Feb2016): New information based on the information received by Pfizer from Merck (Service Request Number# 1-14186003814) includes: new event added and details provided. Follow-up (29APR2016): Follow-up attempts are completed. No further information is expected.
Swollen left axilla noticed 2 days after 2nd covid vaccine2/4/21.  (same side as the vaccine was given) I had  a mammogram done 2/16/21 and was told I had abnormal results in my left lymph nodes in axilla.   I had a left axilla ultrasound done 3/9/21 and the lymph nodes are still abnormal.  I have been asked to come back in 8 weeks for another ultrasound.
Chills, achy, headache, fatigue, large red area at injection site that is warm to touch: 7? x 3"
This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose taken more than 35 days ago, did not get second dose), ADVERSE REACTION (Severe reaction), NAUSEA (Nausea), MYALGIA (Body aches) and HEADACHE (Slight headache) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D40A21A) for COVID-19 vaccination. Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL + HIDROCLOROTIAZIDA), DOXEPIN, LEVOTHYROXINE, LANSOPRAZOLE, FAMOTIDINE, ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), METHYLCELLULOSE (CITRUCEL), VITAMIN D3, FLUTICASONE PROPIONATE (FLOVENT), ALBUTEROL SULFATE, CHONDROITIN SULFATE (BIOFLEX CHONDROITIN), GUAIFENESIN (MUCINEX), OMALIZUMAB (XOLAIR), FLUTICASONE, MELOXICAM, GABAPENTIN (NEURONTIN), IVERMECTIN and METRONIDAZOLE for an unknown indication. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced NAUSEA (Nausea), MYALGIA (Body aches) and HEADACHE (Slight headache). On 09-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose taken more than 35 days ago, did not get second dose). On an unknown date, the patient experienced ADVERSE REACTION (Severe reaction). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose taken more than 35 days ago, did not get second dose) had resolved and ADVERSE REACTION (Severe reaction), NAUSEA (Nausea), MYALGIA (Body aches) and HEADACHE (Slight headache) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medication was provided. The patient had a severe reaction after the first dose, so the patient did not get the second dose. The patient asked if the patient could get a second dose. Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: follow up information : reporter address updated, first dose start date was updated,  New events were added (missed dose and adverse reaction), added concomitant medications
The pt arrived on 1/4/10. He received multiple vaccinations on 1/5/20 at which time he was healthy. He had no adverse reactions. On 1/7/10 he noted that he felt feverish, chilled, had a sore throat, rhinorrhea, slight cough, and body aches which lasted about 4 days. There were other people around him who were also sick. On 2/12/10 the pt received multiple vaccinations. On 2/14/10, the patient experienced fever, chills, diaphoresis, severe sore throat, cough and generalized body aches. He does not recall that others were also sick. On 2/20/10 the pt noted numbness on the bottom of his feet and his fingertips. 2/21/10 he also noted numbness of his lips, tongue and blurry vision. On 2/22/10 he was treated in the ER for a sinus infection and was instructed to follow-up in the am for his neurological symptoms. On 2/23/10 the pt was seen in medical for a headache, blurry vision and numbness/tingling of the bottom of his feet, mouth, and fingertips. The pt was evaluated by a neurologist. PE revealed "stocking loss of sensation in association with areflexia in the legs; subtle breakdown in smooth pursuits coinciding with blurred vision." A NCS was performed. It was felt that the pt most likely had Guillain-Barre syndrome but his symptoms were so mild that treatment was not warranted so the pt was returned went to work with instructions to f/u in 2 days. The pt returned to medical on 2/24/10 with complaints of headache, difficulty walking, numbness in his calves, anus, scrotum and worsening of his blurry vision. He denied bowel or bladder incontinence but he did have urinary hesitancy. The pt was reevaluated by the neurologist and released due to "no progression in his paresthesias". The patient was admitted to the hospital for observation. The physical exam revealed distal areflexia, ataxic gait, instability with Romberg testing, muscle strength and tone was 5/5 and symmetric in BLE/BUE. Over the next 48 hours the patient's symptoms progressed to include onset of LBP, generalized myalgias, perioral and facial numbness, difficulty managing his oral secretions and coughing with intake of liquids. On 2/26/10 PE revealed normal BLE/BUE muscle strength and tone, weakness of facial muscles, diminished corneal reflexes, mild dysarthria. The pt was transferred to another hospital with complaints of numbness of his finger tips, feet, legs, hips, pelvis, abdomen up to the rib cage, and difficulty swallowing and talking due to numbness of his mouth and lips, and blurry vision. He was diagnosed with Miller-Fisher variant of Guillain-Barre syndrome. The pt was treated with IVIG 0.8mg/kg daily for 3 days. As of 3/8/10 the pt's headaches were being treated with IMITREX, there was improvement of the facial paresis and pt was ambulating with a cane. Symptoms: numbness, dysphagia, headache, general, numbness, numbness, blurred vision, numbness, fever, chills, diaphoresis, pain, muscle pain, cough, productive, fever, chills, pain, nasal drainage, cough, productive, muscle pain.
FULL BODY ACHES AND PAINS,  FOR 3 DAYS      ACETAMINOPHEN
Patient had injection site reaction approximately 5 cm in diameter. Area is hard, erythematous, and warm. Mildly tender.
Appendicitis (could have not been related but worth reporting in the event there is a  correlation)
No adverse events reported, only reporting an administration error. When giving the vaccine, the needle came loose from the syringe and less than half of the dose was given in the patient's right deltoid. I contacted Moderna support and was advised that if less than half the dose was administered the first time then to re-administer the full dose of the vaccine in opposite arm. So I administered the full dose of 0.5mL in the patient's left deltoid. Patient has not reported any adverse events from this situation.
shots given on 7dEC94 sl cold sx @ time; afebrile that evening pediacare given for cold sx; later in noc; cried for 2 hrs stretches-high pitched-inconsolable; recurrent crying episodes throughout noc; examined next day; no ear infect;
Headache, lightheaded, nausea, dizziness, muscle aches, malaise, and chest "squeezing" prior to syncopal episodes x 3. This occurred in OR where she works. "I don't know when I passed out." Rapid Response called s/p sternal rub by MD not effective. Taken to ED via stretcher. In ED, had EKG, IV fluids, Benadryl, and Phenergan. Regained consciousness on arrival to ED. Cleared to return to work on 12/24 by MD in ED. Will follow up with PCP.
Information has been received from a registered nurse, concerning a 71 year old female patient, who on 16-APR-2008 was vaccinated IM in the left arm, with a dose, 0.5 mL, of pneumococcal 23v polysaccharide vaccine (lot # 658673/0990U). Concomitant therapy included lisinopril (manufacturer not specified). On approximately 17-APR-2008, the patient developed an "injection site reaction," with redness and pain at the site. On 18-APR-2008, she was seen in the office and stated she "felt better than yesterday" (treatment not specified). At the time of this report the patient was recovering. This is one of 3 reports from the same source. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/30/2008.  Initial and follow up information has been received from a registered nurse and a licensed practical nurse concerning a 71 year old female who on 16-APR-2008 was vaccinated IM in the left deltoid with a 0.5 ml of PNEUMOVAX (lot # 658673/0990U) at 2:00 PM.  Concomitant therapy included lisinopril (manufacturer not specified).  On 16-APR-2008 (previously reported as approximately 17-APR-2008) the patient developed an "injection site reaction," with redness and pain at the site and surrounding area.  On 18-APR-2008, she was seen in the office and stated she "felt better than yesterday" (treatment not specified).  At the time of the report the patient was recovered.  This is one of 3 reports from the same source.  Additional information has been requested.
Since the vaccination, has the patient been tested for COVID-19; Since the vaccination, has the patient been tested for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 14Nov2021 15:00 (Lot number: FH8027) at the age of 46 years as dose 3 (booster), single, administration date 30Mar2021 15:00 (Lot number: ER8733) as dose 2, single and administration date 09Mar2021 15:00 (Lot number: EN6706) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing), notes: other medical history: Depression. Concomitant medication(s) included: BUPROPION. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Jan2022, outcome "unknown" and all described as "Since the vaccination, has the patient been tested for COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Jan2022) positive.  Clinical course: Patient had no allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine.  Follow-up attempts are completed. No further information is expected.
Tender at site of vaccine ((L) arm) extending to shoulder, neck, axilla, (L) breast.
Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 (dose and route unknown, lot# L038917, expiration date: 20-FEB-2018). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
swelling edema on each thigh;lethargy;projectile vomit;eyes glassy;pupil sluggish; T103;inconsolable,high pitched crying;somnolence;egg size mass lt inj site;lt leg stiff-would not bend;scream w/pain when touched;arching back;poss sz;
This case was reported by a pharmacist via sales rep and described the occurrence of cough in a 70-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, immediately after receiving SHINGRIX, the patient experienced cough. On an unknown date, the outcome of the cough was unknown. It was unknown if the reporter considered the cough to be related to SHINGRIX. Additional details were provided as follows: The patient started coughing soon after the vaccination with SHINGRIX and kept coughing for 10-15 minutes. The reporter made the patient stayed until she stopped coughing. The patient coughed later the day, but could not remember if it was that night or not. The follow up would be requested.
Patient experienced local bruising at site of injection, which was still present on 09/11/14. Patient also experienced swelling, tenderness, redness, and warmth in the lower region of her upper arm that began about 3 inches below injection site that was approximately 3-4 inches in diameter. Symptoms last about 7 days.
chest pain, not consistent with pericarditis/myocarditis, after recieving Bivalent covid vaccine, patient is unsure which manufacturer
Parent called 6/26/07 to report that child became very ill with a severe headache, sweats, fever, GI , rash on cheeks, after receiving Hep b#2. Recommended taking child to MD and be evaluated, was told family does not have a provider as yet, recommended ED. This is the 2nd time this child has had a become ill, after the 1st Hep B#1 5-6 days after injection child became ill GI, flu like symptoms, but Parent didn't think to much of this reaction, until after this incident. Parent reports that this child never get ill and has always been very healthy. Parent did not take child to the ED (no insurance, or provider) family is working on getting a provider and health insurance for the children
About  1 week after the 1st dose 2/22/2021,  I started to notice the tips of my right  fingers (index, middle, ring, pinky) red pustules (they look look herpes virus/cold sores). Around that time, I also got chronic daily diarrhea. I went to see my PCP on 3/8/2021 and was prescribed a stool study.  I did a stool study on 3/9/2021 and everything came back negative and normal.   I went ahead and decided to get my 2nd dose of Moderna on 3/22/2021.   I went to  my dermatologist on 3/23/2021 to have her look at my covid fingers  and was diagnosed with "pink erythermatic purpuric papules" most likely from the covid-19 vaccine.   She also suspected that I may have had asymptomic mild covid illness and my covid fingers developed after the vaccine.  I was prescribed a clobetasol topical cream and Valtrex oral tablets.   After 3 weeks, my covid fingers resolved.   I was still having diarrhea.    On 3/30/2021 I went to see a GI specialist for the diarrhea and I did blood work and various studies to find the source of the diarrhea, which all came back normal.  For the diarrhea, I was prescribed Xifaxan every 8 hours for 2 weeksfor the diarrhea.  The medication has help the diarrhea,   The diarrhea has improved but has not completely resolved.
Patient experienced soreness and tenderness in the armpit on the same arm the vaccine was administered in the next morning.  The swelling improved every day and is now gone.
Heart palpitations overnight. Rapid heartbeat for several hours next morning, often 100-120. Fever 2.2 degrees above my normal morn temp.  Improved over several hours, but remained 1 deg.high. Rest & water. Resolved next day.  Vaccine arm itchy & pink-red patch 2-3 days later. Daily cool compresses, but grew to reddish 3"x5" over 7 days, then faded. Occasional itchiness persisted.  Details. Resting HR was 92; declined to 84; by afternoon, to low 70s.  Much higher than my normal rate of 55-59. Took several days to return to normal.  HR taken by Smart Watch; confirmed by Omron BP device and neck pulse.  Note:  I consulted cardiology office twice via phone.  Not listed on the right, so I checked "office visit" instead.
sick with the flu; sick with the flu; Initial information was received on 26-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via social media. This case involves an unknown age male patient who experienced sick with the flu (influenza and illness) after receiving vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination 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 and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick with the flu (influenza and illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  It was reported "My husband used to get the flu shot every year and every year he'd get sick with the flu. Two years ago, he stopped getting the flu shot and hasn't gotten sick with flu since. To each his own I guess."  It was not reported if the patient received a corrective treatment for the events.  At the time of reporting, the outcome of events was reported as unknown.  There will be no information available on the batch number for this case.
PATIENT EXPERIENCED REDNESS, SWELLING, AND WARMTH TO THE TOUCH ON THE INJECTED ARM.  THE PATIENT CAME TO THE PHARMACY ON 10/9/15 AT 7PM TO THE PHARMACIST.  HER ARM WAS RED, SWOLLEN, AND WARM TO THE TOUCH. SHE HAD BEEN TAKING MOTRIN OVER THE COUNTER WHICH SHE SAID HAD BEEN HELPING.  PHARMACIST RECOMMENDED TAKING SOME BENADRYL AS WELL AND REPORTING TO HER PCP.
Per doctor, it is a localized allergic reaction on left upper arm. Treatment-hydrocortisone cream, ice pack, and Benadryl  Recommended to take the 2nd dose
Malignant neoplasm of pyloric antrum. Hospital admission within 6 weeks of receiving the COVID vaccine.
RN was vaccinating a stormy and stuck herself with a dirty needle while trying to activate safety device.