chrisvoncsefalvay/vaers-outcomes huggingface dataset:
From initial information received from a health care professional through a manufacturer's sales force representative on 10/6/04 regarding an adverse event occurring in the USA, it was reported that a child (no specific information provided), received INFLUENZA VACCINE on 9/17/04. The manufacturer, lot number, route and site of administration were not reported. Ten days later, on 9/27/04, the patient presented to the physician with bruising. Blood work was drawn and showed a decreased platelet count. The patient was subsequently diagnosed with idiopathic thrombocytopenia purpura. The patient's recovery status is currently unknown. From additional information received on 29Oct04 through a telephone call to the responsible physician, the office fax number was provided by a nurse at the facility. No additional information relevant information was provided for the adverse experience. This follow up information is not submitted to the health authorities. From additional information received on 22Nov04 from a health care professional, it was reported that the pt was a five year old male who received his fifth dose of Fluzone SV 2004-2005 USP vaccine, lot number U1383AA, administered IM in the arm on 16Sep04. Reportedly seven days later, on 23Sep04, the pt developed idiopathic thrombocytopenic purpura. The pt had no signs of the idiopathic thrombocytopenic purpura prior to the vaccination. His platelet count was 3,000. The pt reportedly recovered by 07Oct04. No further information is anticipated, this case is considered closed.
No additional AEs were reported; patients received improperly stored vaccines; This spontaneous report was received from a licensed practical nurse (LPN)referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 14-MAR-2022, the patient was vaccinated with improperly stored doses of the vaccines vaccine, live, oral, pentavalent (ROTATEQ) 1 dose (exact dose, route of administration, vaccination scheme frequency, and anatomical location were not reported; lot number u026664 with expiration date 24-FEB-2023 or lot number 1741817 with expiration date 30-JUL-2022) and of the vaccine haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 1 dose (exact dose, route of administration, vaccination scheme frequency, and anatomical location were not reported; lot number u026217 with expiration date 02-NOV-2023); both as prophylaxis (product storage error). The administered doses of the vaccines experienced a temperature excursion of 34.3 degrees Fahrenheit for 55 minutes. There was no previous temperature excursion. No additional adverse events (AEs) were reported.  This is one of several reports received from the same reporter.
area swollen & warm to the touch & inconsolable crying for sometime; (gave APAP & comfort measures, warm packs to area);
This spontaneous report was received from an 83 years old female consumer refers to herself with thyroid and high cholesterol problems. The patient had no pertinent medical history and drug reaction/allergies. On 07-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot# unspecified), one time injection, route and location unspecified. Concomitant therapies were taken for thyroid and high cholesterol. On Sunday, 11-AUG-2013 the patient started feeling light headed and unsteady on her feet. No treatment was given for feeling light headed and unsteady on her feet. The patient did not seek medical attention. In May 2013, the patient had lab work everything was good. Therapy with ZOSTAVAX was reported as continued. At the time of report, the outcome of feeling light headed and unsteady on her feet was unknown. Additional information is not expected.
This case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a 48-year-old female patient who received SHINGRIX (batch number Z9RR4, expiry date 15th November 2020) for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 27th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 20th June 2018, the patient received the 2nd dose of SHINGRIX. On 27th April 2018, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced inappropriate age at vaccine administration. On 20th June 2018, the patient experienced drug dose administration interval too short and inappropriate age at vaccine administration. On 1st August 2018, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and arthralgia. On an unknown date, the outcome of the vaccination failure, shingles, arthralgia, drug dose administration interval too short, inappropriate age at vaccine administration and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the vaccination failure, shingles and arthralgia to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The patient was administered the second dose of the SHINGRIX vaccine 7 days early than the recommended interval, which led to shortening of vaccination schedule. On 1st August 2018, 96 days after receiving 1st dose of SHINGRIX and 42 days after receiving 2nd dose of SHINGRIX, the patient presented to physician's office with moderate Shingles rash and severe pain on her right ankle and right upper lateral hip. The patient paid cash at the pharmacy to get the vaccine. No further details were provided.
9-28-2013 7:00 PM blood pressure shot up to 200/98, very dizzy, could not walk very good. Same condition for several days. In previous years (yearly) no bad effects.
Information has been received from a pharmacist, concerning his 16 year old daughter who on 14-AUG-2007 was vaccinated with the first dose of Gardasil (lot # not provided). There was no concomitant medication. In August 2007, "within the first 14 days" after the vaccination, she experienced diarrhea, that initially occurred up to 6 times daily. A stool culture was done and was negative (date not specified). At the time of this report, his daughter had not recovered, with diarrhea continued at up to 3 episodes daily. Additional information has been requested.
Client reports feeling warm the evening of the vaccination and the next day. Client says she had a sore arm right after the vaccine. She said the soreness went away and then came back. 3 days later, arm is still stiff and sore (cannot raise above half way). Bruise at site of injection.
No adverse event; Accidentally received Moderna Bivalent booster instead of first primary dose; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (Accidentally received Moderna Bivalent booster instead of first primary dose) and NO ADVERSE EVENT (No adverse event) in a 25-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Seafood allergy and Penicillin allergy.    On 30-Nov-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Accidentally received Moderna Bivalent booster instead of first primary dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Accidentally received Moderna Bivalent booster instead of first primary dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant medications were not reported.                                        No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2022: Non-significant Live Follow Up information received.
Pain immediately upon completion of injection, with slight tingling in hand. Within 2 minutes of injection, pain was experienced at site of injection in the arm. Within 30 minutes of injection, arm had very limited range of motion resulting in inability to lift arm away from myself and severe pain. Discussed symptoms with pharmacist at clinic and was told if symptoms do not improve within 4 days, contact doctor and to take ibuprofen for symptoms in the meantime. Contacted PCP 2 hours post injection due to how severe pain was and was told pain was normal and should clear up. 24 hours post injection- symptoms still remained - very limited range of motion of arm and severe pain at site of injection and surrounding area in arm and into shoulder and neck. 48 hours post injection- pain less severe and increased range of motion in arm. 72 hours post injection- slight increase from 48 hours in terms of range of motion and slight decrease of pain. Currently still monitoring symptoms and taking ibuprofen.
39 hours inpatient admission. Patient is a 74-year-old female with a past medical history of Alzheimer's dementia, hypothyroidism, hypertension, diabetes mellitus type 2 who presented to the emergency department after mechanical fall.  She tested positive for COVID-19 on 01/05/2022 1 multiple family members were positive.  She was noted to have a fall that was unwitnessed by her family currently on anticoagulation.  Family felt he has been falling more often recently.  As far as COVID symptoms, family stated that in the last 2 days she has had a cough, nasal congestion, generalized fatigue and weakness and diarrhea.  She also had nausea without vomiting.  She is fully vaccinated and boosted.  Upon arrival of EMS, she was found to be hypoglycemic with blood sugars in the 40s.  She was given dextrose with improvement.  She arrived in the emergency department with stable vital signs.  Head CT showed no acute process.  Blood work showed a potassium of 2.0, but was otherwise unremarkable.  She did end up with a magnesium level that was low as well.  Magnesium and potassium were replaced.  Her potassium improved.  Family was consult increased potassium in her diet or use supplements.  She should follow-up with her PCP for further lab work.  Her A1c was 5.1.  Her Lantus and metformin were held initially.  Blood sugars increased with eating, but were still not very high.  She was discharged without Lantus or metformin.  She was told to follow-up with her PCP and to monitor her blood sugar at home.  Initially there was concern for a urinary tract infection, but sample was contaminated with 13 squamous cells.  Repeat UA with straight catheterization showed moderate leukocytes, small blood in the 100 white blood cells.  This was not felt to be a true urinary tract infection and was likely asymptomatic bacteriuria.  Her symptoms were consistent with COVID-19.  Rocephin was initially started, but was stopped upon these results.  PT/OT recommended home with family.  She was discharged home on 01/09/2022.
Approx. 30 minutes after receiving vaccine, child broke out in rash. It started above his eye lids, and in the anticubital fossa of both arms, then progressed all over his body. He had fever and was cranky. No redness at injection site. Also watery eyes. No meds given, but was seen by PMD.
Itchy red rash/urticaria at injection site that developed on the evening of day 7 after vaccination.  Not debilitating... improved with topical cortisone cream. Present all of day 8 after vaccination and so far still present on first half of day 9.
OVERNIGHT I HAD SOME SORENESS AND SWELLING AT THE INJECTION SITE.  AFTER 24 HOURS I HAD FEVER, HEADACHE, BODY ACHES, THE SITE HAD A 3 INCH CIRCLE THAT WAS HARD, SWOLLEN, AND TENDER TO TOUCH AFTER 44 HOURS I HAD THE SAME SYMPTOMS.  THEY WERE REPORTED TO THE DOCTOR'S OFFICE, I WAS ADVISED TO TAKE CLARITIN AND IBUPROFEN, USE COOL COMPRESSES
States arm was sore after receiving vaccine, used ibuprofen. Two days later developed chest and back pain, arm was tingly, uncomfortable. Went to see medical provider, EKG, chest x-ray, and labs were done. Other than showing an elevated WBC count everything was ok. She is feeling better at present, symptoms have subsided but not completely gone.
Pt complained of itching on left arm, shortly after vaccine. She had more itching through the night. Did not tell nurse about the itching on 12/5/00. Came in to clinic the following morning. Left side of face was swollen. Had hives on upper extremities. BP 130/60; P-76. Gave Benadryl and prednisone.
Developed Coronavirus; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Developed Coronavirus) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced COVID-19 (Developed Coronavirus). At the time of the report, COVID-19 (Developed Coronavirus) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, COVID-19: positive (Positive) Developed Coronavirus on 11-JAN-2021.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
h/a in evening 8JUL96;elevated temp (2nd day 102.0) 9JUL96;tiredness/fatigue;
Swelling in elbow, into upper back, severe shoulder joint pain. Unable to lay on right side. Her pain and swelling persisted for two months before she sought treatment. She has been diagnosed with lymphedema and had a palpable mass at the site of injection. After several sessions of physical therapy, she has only regained 60% use of her right arm.
Patient became so dizzy she almost passed out and continued to be so dizzy for 4 days she couldn't get out of bed. She continues to have dizziness for over a year since the shot.
Narrative:  Pt is a 67 yo male with PMH of CAD, STEMI s/p PCI, multiple CVAs, reported history of PE, ruptured cerebral aneurysm s/p coiling, HTN, HLD, COPD, OSA, and paroxysmal AFib (on Xarelto) that presented to the ER on 3/15/21 with shortness of air and cough. Pt received 2nd COVID-19 vaccine on 3/1/21 during inpatient stay for CHF exacerbation and was discharged on 3/3/21. Pt reports that one day after discharge, SOA increased and he developed cough and nausea; family members began having the same symptoms as well and tested positive for COVID-19. Pt came to ER on 3/15 after having difficulty speaking bc of SOA while on 2L NC. Pt was admitted with COVID-19 pneumonia and transferred to ICU. He was intubated, given fluid boluses, and started on norepinephrine, linezolid, and tube feeds. Pt's principle diagnosis while admitted was acute hypoxic respiratory failure requiring mechanical ventilation with cardiogenic and septic shock and multiorgan failure due to COVID-19 pneumonia. Noted that pt developed symptoms of COVID-19 within days of 2nd dose and would not have been considered fully vaccinated against the virus.
Intense cramping and diarrhea that came on suddenly. Lasted a little over an hour
Treatment of COVID-19; Treatment of COVID-19; 4th dose got Moderna; 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 61-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6205), in left arm, on 24Mar2021 as dose 2, single (Lot number: ER8727), in left arm and on 22Oct2021 as dose 3 (booster), single (Lot number: FH8020), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 30Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Cholesterol" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; LEVOTHYROXINE; OMEGA-3-ACID ETHYL ESTER. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Apr2022, outcome "unknown", described as "4th dose got Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19; (2022) Positive, notes: Rebound of symptoms plus positive Covid test 8 days after finishing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient was treated with Paxlovid. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 19 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A, and expiry: 21-SEP-2021) .5 ml, start therapy date was not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211006668, 20211006371, 20211018789 and 20211009653.
This spontaneous report was received from a female patient of unknown age regarding herself. The patient's concurrent conditions included diabetes mellitus and chronic psoriasis. The patient began receiving ZOSTAVAX and GARDASIL in the beginning of 2007 to cure her chronic psoriasis. The patient's ZOSTAVAX initial vaccination began on an unspecified date in 2007; with another follow-up dose towards end of 2007. The patient then received up to another 7 extra doses of ZOSTAVAX between 2007 and in 2016. During this time frame the patient also received 5 or 6 separate doses of GARDASIL. She stated that the combination and amount of vaccinations had all but 'cured' her acute case of psoriasis. In order to receive the above mentioned treatment, the patient sometimes received each vaccine under an alternate assumed name among others. Additional information has been requested.
Patient states received Moderna vaccine lot # 004M20A-  first dose on 01/22/2021 Developed sore arm and localized redness at vaccination site x 2 days, then disappeared.  Then noticed a hard, bright red itchy lump on 01/29/202, same site    Patient is alert and oriented- no audible distress Denies fever/chills/sweats Denies any resp/swallowing difficulty    Did not try any cool compress or antihistamine  Redness measures about 4x4 inches diameter  Overall improving, no streaks No pain Not itchy now  Less warm to the touch  Denies other hives/rash
- Red rash at site of injection on day 2 after first injection - muscle pain/stiffness 3 hours after first injection and up to day 3 - low grade fever 10 hours after injection and continuously until day 3 - headache 6 hours after injection and on and off until day 2
soreness in her shoulder also; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in her shoulder also) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness in her shoulder also). At the time of the report, VACCINATION SITE PAIN (soreness in her shoulder also) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported by the reporter No treatment medication reported   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow-up information received on 04-MAY-2021 contains updated outcome of the event as recovered.
Shot may not have been administered properly and as a result I have been unable to move my arm freely.  There is localized pain and a burning sensation including joint pain.  I am unable to use my arm for normal activity.
I was told Monday (10/22/07) morning that a pharmacist may have given a flu shot in a patient's hip rather than in the deltoid.  I looked through the consent forms and found one for patient stating that the shot was administered in the hip.  It is my understanding that the patient insisted she be given the shot in the hip as she could not take in the arm.  No symptoms reported at this time.
Employee gave no warning and jammed needle into arm. Immediately, I hunched over in pain, never had this happen from a flu shot before. My arm was sore for a couple weeks, and slowly got worse and worse. As of today, March 13, 2021, I do not have full mobility in my arm (cannot wash myself properly, dress myself etc.), and experience sporadic severe pain. I cannot perform daily functions as normal.  I asked my doctor to fill out this form; he said he could not do it as it asks for personal information which he does not have access to. I have seen this doctor twice about my arm, then had. an X-ray. I will see a physiatrist next week. Problem is not resolved.
WHEN NEEDLE WAS REMOVED THERE WAS A SMALL AMOUNT OF BLOOD ATHAT CAME FROM THE INJECTION SITE AND I NOTICED THE TISSUE SWELLED SLIGHTLY ALMOST IMMEDIATELY. THE PATIENT SAID THEY FELT NOTHING I WAS CONCERNED BY THE SLIGHT SWELLING. AFTER 20 MINUTE PERIOD PATIENT WAS OBSERVED AGAIN FOR PRECAUTION AND THERE WAS NO CHANGE . PATIENT SAID THEY FELT FINE AND WAS UNDER NO DISTRESS. THE SITE WAS NOT RED OR INFLAMED JUST VERY SLIGHTLY SWELLED.
Patient came through the drive thru stating They had just gone for ice cream and had swelling in corner of mouth. Only thing different was flu shot. No difficulty breathing/swallowing. Pt contacted MD instructed to take Benadryl followed up w/ pt the following morning swelling resolved + said feeling good.
Moderna COVID?19 Vaccine EUA 2-inch red spot surrounding injection site appeared 8 days after injection.  Itching, no pain.  treated with topical Benadryl. Symptoms subsided in 3 days.