chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A, 010M20A and 038B21A) for COVID-19 vaccination.     The patient's past medical history included Renal insufficiency, Diverticulosis, Otitis media, Sinusitis, Viral infection, Headache, Tension, Lung cancer, Skin cancer, Chest wall pain, Prostate cancer, Ankle sprain, Colon cancer, Thrombocytopenia, Vitamin B12 deficiency, Neck pain, Back pain, Osteoporosis, Allergic rhinitis and Bundle branch block right. Previously administered products included for Product used for unknown indication: Influenza Vaccine (series 1) on 02-Oct-2019, Influenza vaccine (series 3) on 15-Oct-2021, Influenza Vaccine (series 2) on 15-Oct-2021, Influenza vaccine and Influenza vaccine. Past adverse reactions to the above products included No adverse reaction with Influenza Vaccine, Influenza Vaccine, Influenza vaccine, Influenza vaccine and Influenza vaccine. Family history included Heart disease, unspecified. Concurrent medical conditions included Spinal stenosis in cervical region and Hyperlipidemia. Concomitant products included DICLOFENAC SODIUM (VOLTAREN [DICLOFENAC SODIUM]) for Headache tension, SIMVASTATIN, CUCURBITA PEPO OIL, SERENOA REPENS, ZINC GLUCONATE (SAW PALMETTO [CUCURBITA PEPO OIL;SERENOA REPENS;ZINC GLUCONATE]) and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Prostatic specific antigen increased: increased (High) increased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient has to check for HEMOCCULT or sigmoid  Patient had to take Flu Vax, Pneumovax,TD Booster vaccines.
A non-serious, spontaneous report of administered FLUMIST to adult greater in age than 49, from a physician involving a 76 year-old patient subsequent to FLUMIST. The event was reported 19 days after the administration and the physician indicated the patient was doing fine and no reactivity was reported. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.
Complained of leg pain, rash. Dx shingles, Rx Zovirax.
WHEN I SAT UP IN BED UPON AWAKENING, I WAS HAVING A SENSATION OF REELING (NOT A SPINNING ROOM-MAYBE LIKE LOOKING OVER A CLIFF OR BEING ON A ROCKING BOAT) I HAD NO CONTROL OVER MY SWAYING BODRY) THIS LASTED PERHAPS 30 SECONDS-1 MINUTE. AGAIN OCCURED THAT MORNING WHILE SITTING ON TNE TOILET. THE EVENT REPEATED ITSELF FOR A WEEK. ON OCTOBER 10, 2015 I NEEDED TO CALL AN AMBULANCE AS THIS REELING AND SWAYING OCCURRED WHILE WALKING. I WAS SENT HOME FROM THE ER WITH NO DIAGNOSIS. (PERHAPS UNRELATED- ON 10/14/2015 HAS AN EPISODE OF SYNCOPE WHEN AT THE ENT OFFICE. DR SENT ME TO ER, UPON WHICH I WAS HOSPITALIZED. AFTER MANY SPECIALISTS (CARDIAC, ENT, NEUROLOGY NO DIAGNOSIS YET) I WAS EXPERIENCING ORTHOSTATIC HYPOTENSION WITH TACHYCARDIA IN THE HOSPITAL.
Began with chills that progressed to violent chills with my whole body trembling and my teeth chattering. I also have a dull headache and my arm is very sore. This is subsequent to my second vaccine. After the first vaccine in July, I had a very bad headache as well as a very sore arm.
lt upper arm pink 8cm area nl temp very itchy-treated w/DPH/cool compresses;
Prolonged crying x 3-4 hours after vaccine administration. Family gave Tylenol, but at sub therapeutic dose. Crying subsided after correct dose based on weight was given.
Lack of efficacy; COVID positive; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Lack of efficacy) and COVID-19 (COVID positive) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXINE [LEVOTHYROXINE SODIUM]) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, the patient experienced DRUG INEFFECTIVE (Lack of efficacy) and COVID-19 (COVID positive). At the time of the report, DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown and COVID-19 (COVID positive) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) tested negative, a few days earlier. On 09-Nov-2021, SARS-CoV-2 test: positive (Positive) Positive (taken swab test sample).         No treatment medications were reported.  The COVID symptoms started about 5 days prior to the patient's husband's onset and manifested as extreme painful nausea, stomach pain, dry breathing, dry cough, headache, exhaustion, diarrhea, cold sore in the mouth and terrible taste in the mouth (like blood, rubber) in the patient. The patient was having a difficult time. This is a Spontaneous case concerning a -year-old, male/female patient with unknown medical history,  who experienced the unexpected non serious (AESI) events of COVID 19 and Drug ineffective. The event occurred approximately 9 months and 13 days after the first dose and 8 months and 16 days after the second dose of Moderna COVID 19 vaccine. The rechallenge is not applicable.  The benefit-risk relationship of Moderna COVID 19 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case concerning a -year-old, male/female patient with unknown medical history,  who experienced the unexpected non serious (AESI) events of COVID 19 and Drug ineffective. The event occurred approximately 9 months and 13 days after the first dose and 8 months and 16 days after the second dose of Moderna COVID 19 vaccine. The rechallenge is not applicable.  The benefit-risk relationship of Moderna COVID 19 vaccine is not affected by this report.
Pt called with symptoms of chills, severe muscle pain, swelling, and a red line that started below the injection site and ran to the arm pit.
3 days post vax pts parent noticed a deep red area in arm pit that appears to be spreading and weeping a little bit. Pt experiencing some muscle aches. Pt treated with Tylenol
This case was reported by a nurse to a sales representative and described a female patient who received hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix) and subsequently tested positive for hepatitis A antibodies.  On an unspecified date in February 2004, the patient received the first dose of Twinrix.  Approximately one month after the administration of Twinrix, on an unspecified date in March 2004, the patient was anti-hepatitis A positive.
1) headache and muscle aches days 2 - 4 2) extreme fatigue day 4 3) very dark urine day 5
PATIENT STATED THAT THE INJECTION SITE ON THE RIGHT ARM WAS SORE, SWOLLEN, AND WARM TO TOUCH.
Pt recv vax on 10/21/98; on 10/23/98 pt exp headache, chills & shaking
3/20/13 GM home at 5:30pm observed rash over entire body (hives), injection site swelling, red & hot, BENADRYL given by GM, lip swelling, coughing & breathing difficulty. To ER at 6pm. Steroid Tx, breathing Tx, nausea med & BENADRYL given by ER & chest X-ray. Home with prednisone. F/U at physician's office on 3-22-13 prednisone stopped.
On Aug 10 I had completed a mammogram/exam and all was good. On Sept 11 I had my first shot in my left arm and had no reaction. On Oct 3 I had my second shot in my right arm. Within 24 hours the lymph nodes in my neck near my collarbone (right side) swelled to the point that it was uncomfortable (maybe the size of a small egg). After reading up on this I waited 14 days. After that period of time, the swelling had gone down but did not fully go away (now the size of a marble). After consulting with my DR, an ultra sound was done (I had a lumpectomy done on my left side 5 years ago). The lymph node was measured on November 1 and I was told to return in three mo (Feb 2022) for another measurement.
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On unknown dates the patients were vaccinated with improperly stored ROTATEQ (lot # reported as K012303, expiration date 10-MAY-2016) (dosage and strength unknown) (temperature: -10 degree centigrade, time frame: over a two day period with a cumulative of 12 hours (2 cycles)) orally. No adverse effect was reported. This is one of several reports received from the same reporter. Lot number K012303 is an invalid lot number for ROTATEQ. Additional information has been requested.
Pt recv vax on 12/16/96; on 2/26/99 pt exp breakthrough varicella
Sweating, cough, watery eyes over first hour. Progressing to throat closing, light headedness, passing out.
4 hours after the vaccine, flushing, red face, chest, neck and red eyes.  Throat tightness
COMPLAINT OF RECURRENT "NEURO-MUSCULAR DISEASE SYMPTOMS, SAME SYMPTOMS AS AFTER RECEIVING SWINE FLU VACCINE IN 2009, SMALL FIBER NEUROPATHY" WITH BURNING, ITCHING AND PAIN TO TOES SPREADING TO LOWER LEGS AND JOINTS ACHY.  sYMPTOMS BEGAN 3 DAYS AFTER RECEIVING MODERNA COVID VACCINE ON 5/3/21 AND GRADUALLY WORSENING.  PT PLANS TO FOLLOW UP WITH PCP DR ON 5/25/21.
Information has been received from a registered nurse concerning a 12 month old female who on 09-MAR-2009 and 02-JUN-2009 was vaccinated with a first and second doses of ROTATEQ (lot# not reported). The patient was seen for her 12 month appointment on 27-JAN-2010 and was inadvertently given a third dose of ROTATEQ. No adverse effects reported. The patient did not seek medical attention. Additional information has been requested.
On Dec 3 2008 I had Tetanus shot on the upper left arm. Pain started at night as I can't sleep on my left side. Left arm pain got worse and can't be touched. On Dec 9th the arm pain was better but pain got into elbow, wrist and fingers. In fact 3 fingers got numb. Could not perform work. Went to see Doctor in the PM. The upper arm area is red (looked like rash) and hot. Doctor could not tell if it is infection or allergic reaction. He gave me antibiotics. The medicine seems to work and today I can type again.
He did not have an adverse reaction to the vaccine.  On 01/20/2023, he began not feeling well with a cough, fever and fatigue. We tested him for COVID-19 on 01/20/2023 but it was negative. He was tested for COVID-19 several times and it was negative.  We gave him Tylenol and Motrin to help with his symptoms.
body rashes; This spontaneous case was reported by a consumer and describes the occurrence of RASH (body rashes) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (body rashes). At the time of the report, RASH (body rashes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.
Reports that 24 hrs after inj. of Pneumonia he had redness, warmth, swelling of upper arm down to elbow. Called Pharmacy was told to apply ice
shortness of breathe, fever 102-103, chills, weakness, congestion, dizziness, diarrhea for 36 hours - tried to treat with ibuprofen and tylenol
COVID test result: Positive; COVID test result: Positive; heaviness in left arm and left leg; Chest pain; rapid heart rate; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 10-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13May2021 at 11:30 as dose 1, single (Lot number: FJ5682), in left arm, on 03Jun2021 at 09:45 as dose 2, single (Lot number: EW0183), in left arm and on 07Jan2022 at 11:30 as dose 3 (booster), single (Lot number: FJ5682) at the age of 9 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin", notes: known allergies: Amoxicillin. The following information was reported: CHEST PAIN (non-serious) with onset 10Jan2022 at 08:00, outcome "not recovered"; HEART RATE INCREASED (non-serious) with onset 10Jan2022 at 08:00, outcome "not recovered", described as "rapid heart rate"; LIMB DISCOMFORT (non-serious) with onset 26Jan2022, outcome "not recovered", described as "heaviness in left arm and left leg"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21May2022, outcome "unknown" and all described as "COVID test result: Positive". The events "chest pain", "rapid heart rate" and "heaviness in left arm and left leg" required physician office visit. The patient underwent the following laboratory tests and procedures: Heart rate: (10Jan2022) Rapid; SARS-CoV-2 test: (21May2022) Positive, notes: Nasal Swab; (08Feb2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of chest pain included Ibuprofen.  Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.
Patient came to site on 01/15/2022 for second dose of vaccine and at that time it was discovered she was given Moderna first dose on 11/13/2021.  Due to her age she should not have been eligible for Moderna at 15 yrs old.  She was offered Pfizer, which parent declined.
pt recv vax 9NOV98 & 10NOV98 Pm large red area on 11NOV98 still increasing in size on 11NOV98 on exam + large area of rt thigh (orange size) red/indurated, sl warm, not hot;dx local rx rt thigh;
Rec call from pt stating after TDAP on 3/21/11 she developed fever on 3/22 of 102 degrees & body aches - decreased after APAP area of injection site sl red & swollen but improving did not want to come in.
Approx 48 after vaccination arm became severly inflamed, began to have nausea, low grade fever and body aches. Reportedly had fever > 101, lightheadness, nausea and diarrhea at 72 hours. Approx 90 hours after inject, had syncopal episode with collapse, high fever, diarrhea. Now has slight redness to arm that extends beyond injection site, runny nose and mild nausea. She is afrebile, and other sx have resolved.
Two days after receiving Menactra Vaccine, pt developed worsening asthma symptoms, diarrhea/vomiting, malaise, hypesthesia; Three days after receiving vaccine, had normal exam, but c/o diarrhea and vomiting; no pain or abnormality noted at immunization site.
Patient's mother noticed that the (L) arm of the child was sore on 1-15-14 in the am. Then during the PM that night she noticed it was hard, red and hot. He complained that it itched and hurted.
Fussiness, nausea, vomit, fever, pain and body aches.
Woke up in the middle of the night with severe chills and couldn?t warm up. T max 103.1 F
swollen neck lymph nodes five days after shot; My left arm was swollen; low grade fever; This is a spontaneous report from a contactable consumer reporting for herself. A 74-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL1283), via an unspecified route of administration (left arm) on 21Jan2021 15:00 at SINGLE DOSE for covid-19 immunisation. Medical history included cholesterol (abnormal) from an unknown date. Patient is not pregnant. No other vaccines were given in four weeks. Patient did not have COVID prior vaccination and patient was not tested for COVID post vaccination. Concomitant medications (medications in two weeks) included pravastatin from unspecified date for cholesterol (abnormal); estrogens conjugated (PREMARIN), allopurinol (ELAVIL), ascorbic acid, betacarotene, cupric oxide, manganese sulfate, selenium, tocopheryl acetate, ubidecarenone, zinc oxide (COQ10), aminobenzoic acid, biotin, calcium pantothenate, choline bitartrate, cyanocobalamin, folic acid, inositol, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate (B COMPLEX) from an unspecified date for an unspecified indication. The patient experienced low grade fever on 25Jan2021 that went away but the following morning on 26Jan2021, the patient also experienced swollen neck lymph nodes five days (five days as reported) after shot. Patient stated she does not know if it was going away. Patient's left arm was also swollen on 26Jan2021. Left arm was described as swollen just little bit, not much but that's gone down. The patient stated there was no fever as of reporting, but the swollen lymph node was being reported and since she has been up, it's gone down considerably but she can just feel them a little bit on her neck. Treatment was not given. She mentioned she has a person coming to do a work at the house and wanted to know if it is okay if she still comes. She asked if she should be alarmed about the side effect. She mentioned she was just concerned about if she needs to be concerned about this or if she can be around people. She mentioned she wear masks anyways but just need to know if it is okay if people come into her home. Outcome of the events low grade fever and left arm was swollen was recovered on Jan2021, while unknown for swollen neck lymph nodes five days after shot.
Whole body joints pain for 2 days, Injecting site still in pain for 2 weeks now, Tingling whole body starting at 10th day , still ongoing, Left neck(injected at left arm) pain / stifness on and off, Light headache ongoing
SHAKING; COULD HARDLY GET OUT OF BED; CHILLS; HIGH FEVER; REALLY FATIGUED/SO TIRED; This spontaneous report received from a patient via a company representative concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included stress.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced shaking, could hardly get out of bed, chills, high fever, and really fatigued/so tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, shaking, high fever, could hardly get out of bed and really fatigued/so tired was not reported. This report was non-serious.
Itchy painful,shingles like rash,all over body,only calms down with prednisone.Eight weeks and counting.
Extremely sore arm at injection site the following morning, accompanied by moderate fatigue and lassitude.  Lasted three days, decreasing each day.
Within 5-10 minutes of receiving vaccine, patient stated she was dizzy, nauseated, and felt flushed.  She didn't appear pale, sweaty, or flushed, but she said she had passed out once before when giving blood.  I kept her for observation for about 35 minutes and had her lower her head between her knees.  I offered her water or soda, but she declined.  She did accept a peppermint and stated that it helped her nausea tremendously.  She declined further medical help (e.g. EMS) and left with her boyfriend.  She stated she felt better and wanted to go home. I told her to call me and give me a follow up.
Patient was given incorrect dose of Moderna booster shot. Patient should have received 0.25 milliliters but received 0.05 milliliters in error.
Patient states that within 48 hours of vaccination with 2nd covid vaccine that the rawness on inside of her mouth returned (she experienced this after the first dose as well).  A lot of swelling present in front, back and sides of neck, cheeks and along clavicle bilaterally.  Patient in our office today 6/2/21 and neck still appears swollen but has improved.  States that she did not see the physician until April  when she became worried that swelling may be caused by something else.  Physician ordered an MRI.
c/o dyspnea and fatigue; Caller reports she is still able to perform ADLs without difficulty and questions if sx are anxiety related scheduled herself for covid test 3/16/21 at the clinic  may have been anxiety , saw doctor , everything negative .
her physician has prescribed GARDASIL 9 for her and she is 65 years of age and has not been able to find a pharmacy that will administer the vaccine; No other adverse event reported; This spontaneous report has been received from a consumer referring to herself as a 65-year-old female patient. The patient's concurrent conditions included Human Papilloma Virus (HPV) 14 and on an unknown date, she had a radical hysterectomy. Her concomitant therapies and drug/allergy history were not reported.  On an unknown date, the patient's physician prescribed her hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, anatomical location, route of administration, lot# and expiration date were not reported) (Product prescribing issue).  No adverse event was reported.
Red area swollen/hot to touch measured 3 1/2 x 3 1/2. Pt given rx. for Duricef and hydrocortisone 1% cream.
vacine site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (vacine site pain) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (vacine site pain). At the time of the report, VACCINATION SITE PAIN (vacine site pain) outcome was unknown.            No concomitant product information was provided by the reporter.  No treatment information was provided by the reporter.  This case was linked to MOD-2021-085605 (Patient Link). Based on current available information and the temporal association between product sue and the start of the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-085605 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Follow up received and contains no new information.; Sender's Comments: Based on current available information and the temporal association between product sue and the start of the events a causal relationship cannot be excluded.
Pt recv vax on 10/19/98; on same day pt exp vax site swelling to size of fist, became hard &hot to touch, red, tender, itchy.