chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a patient's mother refers to a female patient of an unknown age. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with the second dose of GARDASIL (dose, route of administration, lot number and expiration date were not reported) too early. No adverse effects were reported. Additional information has been requested.
Case number PHEH2013US015815 is an initial spontaneous report received from a nurse on 23 Jul 2013. This report refers to a 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number; A12123) intramuscularly on 22 Jul 2013. It was reported that he received MENVEO that had been at less than 2 degree C for a 48-hours period time with the lowest temperature reading of minus 14 degree C. No adverse event was reported following the medication error.
In June, I was having back pain from my neck to the middle of my back to my lower extremities. I was also was sick on June 6 with a low grade fever and then on June 7, I went to work and I asked my colleague to draw blood for me because I was having pain. I did check my cardiac enzymes and my troponin was at a high critical level. At 9 times the value of the normal range. I also ran my cardio CRP to make sure I don't have any other inflammation. My CRP was at 38 and the normal value was 0-3. I ran my SED rates and it was at 50. I told my cardiologist that I have this problem and he did not reply. I went home considering that I had the high troponin. My wife said I needed to go back to the ER, so I went to the Hospital and all my records were there. I was admitted for observation in ICU while calling for my cardiologist. At the time, they ordered me a cardiac enzyme and it was elevated, they ordered another one a couple hours later and it was higher. I was admitted to the ICU and they kept me for observation. They ordered many tests and another troponin test and an echocardiogram. That showed that it was normal but the troponin was getting higher and higher. My cardiologist and I talked, and I asked if there was a blood clot or blockage in my heart. They sent me to a heart hospital in the city. They did another x-ray and other tests such as an EKG. Everything seemed normal, then on June 8 in the morning ? I was sent for a CAT scan on me. The doctor found that I don't have any blockage and they said I had Endo pericarditis. The result is normal, but there is inflammation. I was given a high dose of ibuprofen 800 mg a day. I was given Colchicine and took that for 3 months. They also gave me Pantoprazole 40 mgs since July 6, 2022 for one month while I was taking ibuprofen for a week. After taking the medications for a month, I checked my CRP and SED rate were both going down. My CRP was negative and SED rate was also negative.
Sunday, six days after I received the vaccine, my left arm began hurting a lot. On Monday morning, 7 days after the vaccine, I had swollen, a large  painful palpable bump near the anterior part of my armpit. The bump could easily be visualized. The pain was moderate and did affect my activity of daily living. The discomfort could be felt at rest, and took about 5 days to improve. Three and a half weeks later I can still palpate the bump. I am not getting the second vaccine. I did have a mammogram two months ago, which was normal. If the bump does not go away within the next two weeks I will go see my primary care physician.
Severe muscle fatigue, mostly in the legs. Numbness in feet 1 week following administration of vaccine. Progressively worse symptoms following and ongoing at this time. Including the following: numbness and tingling of hands and feet on a daily basis, body fatigue, pain in back, mental lethargy, exhaustion and difficulty breathing at times.
no adverse effects; Patient have been administered doses of improperly stored vaccines; This spontaneous report as received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided.  On 16-MAR-2020 at 10:34, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot # S023219, expiration date on 03-MAR-2022, at a dose of 0.5 mL, intramuscular on the right thigh (RT). On that same day, the patient also received pneumococcal 13v conj vaccine (CRM197), diphtheria toxoid, hepatitis B virus vaccine rHBsAg (yeast), pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (Vero), tetanus toxoid (PEDIARIX) and rotavirus G1 P1 vaccine live (89-12) (ROTARIX). Administered dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced the temperature excursion above 9 degrees Celsius (15.5C) for 4 hour and 6 minutes. Digital data logger was involved. There were no previous temperature excursions reported. The outcome was provided as "supported". No adverse events reported.   This is one of several reports received form the same reporter.; Sender's Comments:  US-009507513-2003USA002275:Original Case : 2003USA002275 US-009507513-2008USA008889: US-009507513-2008USA008876: US-009507513-2008USA008885: US-009507513-2008USA008883: US-009507513-2008USA008890: US-009507513-2008USA008875: US-009507513-2008USA008877: US-009507513-2008USA008878: US-009507513-2008USA008879: US-009507513-2008USA008880: US-009507513-2008USA008881: US-009507513-2008USA008882: US-009507513-2008USA008884: US-009507513-2008USA008886: US-009507513-2008USA008887: US-009507513-2008USA008888: US-009507513-2008USA008891: US-009507513-2008USA008892: US-009507513-2008USA008893: US-009507513-2008USA008895: US-009507513-2008USA008896: US-009507513-2008USA008897: US-009507513-2008USA008898: US-009507513-2008USA008899: US-009507513-2008USA008900: US-009507513-2008USA008901: US-009507513-2008USA008902: US-009507513-2008USA008903: US-009507513-2008USA008904: US-009507513-2008USA008905: US-009507513-2008USA008905: US-009507513-2008USA008907: US-009507513-2008USA008908: US-009507513-2008USA008909: US-009507513-2008USA008910: US-009507513-2008USA008911: US-009507513-2008USA008912: US-009507513-2008USA008913: US-009507513-2008USA008914: US-009507513-2008USA008915: US-009507513-2008USA008916: US-009507513-2008USA008917: US-009507513-2008USA008918: US-009507513-2008USA008919: US-009507513-2008USA008920: US-009507513-2008USA008921: US-009507513-2008USA008922: US-009507513-2008USA008923: US-009507513-2008USA008924: US-009507513-2008USA008925: US-009507513-2008USA008926: US-009507513-2008USA008927: US-009507513-2008USA008928: US-009507513-2008USA008929: US-009507513-2008USA008930: US-009507513-2008USA008931: US-009507513-2008USA008932: US-009507513-2008USA008933:
Employee had hard knot appear at injection site 20 12/26/2020, experienced headache, tiredness, dizziness, and weakness for 4 days.
Mild flu-like symptoms, bruise 1 cm diameter, 10cm diameter red, hot, indurated tissue. Symptoms lasted Thursday the 17th to Saturday the 19th, and fully resolved.
no adverse event; they inadvertently administered the the 6-11 year old bivalent booster dose to a 37 year old patient today, 06Feb2023.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (they inadvertently administered the the 6-11 year old bivalent booster dose to a 37 year old patient today, 06Feb2023.) and NO ADVERSE EVENT (no adverse event) in a 37-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 06-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (they inadvertently administered the the 6-11 year old bivalent booster dose to a 37 year old patient today, 06Feb2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (they inadvertently administered the the 6-11 year old bivalent booster dose to a 37 year old patient today, 06Feb2023.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (they inadvertently administered the the 6-11 year old bivalent booster dose to a 37 year old patient today, 06Feb2023.).    Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. On 08-SEP-2017, the patient was vaccinated with improperly stored doses of VARIVAX lot # M047662 with expiration date 02-DEC-2018, (dose and route of administration were not reported) for prophylaxis (incorrect product storage). Properly stored sterile diluent (DILUENT MERCK INJ) was used to reconstitute the improperly stored VARIVAX. It was stated that the VARIVAX was exposed to a temperature between 15 and 46 Fahrenheit degrees for 2 hours and 50 minutes. Digital data logger was involved. No previous temperature excursion was reported. No adverse effect was reported. There was no product quality complaint(PQC) involved. This is one of the several reports received from same reporter.; Sender's Comments: US-009507513-1710USA007380: US-009507513-1710USA007379: US-009507513-1709USA007245: US-009507513-1710USA007381: US-009507513-1710USA007383:
This spontaneous report as received from a nurse refers to patients of unknown age. On 17-DEC-2013 the nurse reported that 52 patients (demographics unspecified) were vaccinated with PNEUMOVAX23. Lot number and expiry date for PNEUMOVAX23 were reported as J011651 and 22-AUG-2014 respectively. Co-suspect therapies included ZOSTAVAX (lot J011338 exp date 19-DEC-2014) and DTAP both given on 17-DEC-2013. The nurse reported that all patients received PNEUMOVAX23, but that some of the patients may also have received ZOSTAVAX or DTAP administered concomitantly depending on circumstances and history of each patient. Approximately on December 2013 (within 12 to 24 hours following vaccination) the patients developed large and blistered injection site reactions, bigger local reactions, vomiting, nausea, fever, chills and headaches. The patients were treated with ALEVE and ibuprofen. Approximately on December 2013, the nurse reported that some of the patients (unspecified number) have missed 2 or three days of work (disability). The outcome of missed 2 or 3 days of work, bigger local reactions, some vomiting, nausea, fever, chills, headaches, patients developed injection site reactions and large and blistered was reported as recovering/resolving. The nurse reported that some of the patients are recovering quicker than other patients, but all are expected to completely recover. Causality of events was unknown. This case is linked to 1312USA010164 via same reporter link. Additional information has been requested.
50 yo patient with minimal past medical hx (no cardiac disease or prior VTE) presented with dyspnea on exertion and CP after receiving pfizer vaccine booster shot on 10/4/21.   SOB and CP developed 5 days after shot was administered.  Found to have bilateral pulmonary emboli with signs of right heart strain. started on anticoagulation.
pt began developing diffuse redness and cough approximately 10-15 min post immunization. Within 30 min, pt had bright red urticarial rash from face to hind thigh. Lungs plus wheeze with decreased breath sounds after 2 albuterol nebs, O2 at 6 liters and 2 Epi Renal, within one hour, rash and wheezing resolved.
12 April 07 (PM) developed fever 102 self tx with tylenol and had to take leave from work on 13 April 07
Complaining of fever, left arm hurts for 2 days with increased redness and soreness at site; 2cm diameter, erythema with mild induration.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. On 08-SEP-2017, the patient was vaccinated with improperly stored doses of VARIVAX lot # M047662 with expiration date 02-DEC-2018, (dose and route of administration were not reported) for prophylaxis(incorrect product storage). Properly stored sterile diluent (DILUENT MERCK INJ) was used to reconstitute the improperly stored VARIVAX. It was stated that the VARIVAX was exposed to a temperature between 15 and 46 Fahrenheit degrees for 2 hours and 50 minutes. Digital data logger was involved. No previous temperature excursion was reported. No adverse effect was reported. There was no product quality complaint(PQC) involved. This is one of the several reports received from same reporter.; Sender's Comments: US-009507513-1710USA007379: US-009507513-1709USA007245: US-009507513-1710USA007382: US-009507513-1710USA007380: US-009507513-1710USA007381:
Moderna Covid-19 Vaccine EUA Painful injection site 1 week after injection. The following day a red half dollar size red area developed at the injection site. A day or so later another same size rash appeared about 4 inches below the original area.  In the days following the 2 red areas became 1 and the site was quite itchy and painful.  On or around March 28th the area became raised/swollen however did not appear to increase in size. I treated with otc antihistamine cream.  I did not take anything for the arm pain. Eventually the rash and pain subsided and resolved.
Four bouts of Tachycardia (174 BPM), PVC's, raised blood pressure (170/120), abdominal and intestinal discomfort. Diagnosed hyperthyroid. Different dosages of methimazole and metoprolol. Almost 10 months later and doctors still can't get thyroid level in normal range through meds as I swing from hyper to hypo 3 times already in  almost 10 months. Endocrinologist says thyroid is acting erratic.
Patient developed fussiness at 2 AM on 1/6/01 followed by a fever of 103 degrees and inconsolable crying for 1.5 hours at 4 AM on 1/6/01. Patient was given Tylenol at 2 AM.
Fever and sweating through the night, and fever and hot body upon rising in AM; stiff, sore neck starting about 5-6 hours after injection; headache upon waking in AM; significant shoulder pain. General lousy feeling upon rising day after injection. I did not experience these symptoms with my first injection 2-1/2  months ago. I did have mild pain in my arm.
Had extreme chills approx. 8 hours after being vaccinated. I have had to use my inhaler daily since getting vaccinated which is abnormal for me.  My asthma seems to be heightened since . Unsure if both are related however, it is abnormal for me.
pt states that after she took the covid vax that the following day she had some flu like symptoms.  Four days later she had chills and severe joint pain that was very debilitating.  she had to get a walking cane to be able to get up move around.  she had this joint pain for about 9 days.  pt contacted her PCP and was prescribed Percocet 10mg.  pt has appt w/her PCP on 3/25/2021.
Initial report received from a healthcare professional on 04 December 2013. A 3 year old 1 month old child patient had received a 0.25 ml  influenza USP trival A-B subvirion. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
fever of 100, chills, headache, nausea, body aches, rash
Two weeks after my second Pfizer COVID-19 vaccine shot, I started feeling muscle tightness/soreness in my right pec muscle between my chest and my right shoulder. Shortly after I felt the same thing in my left pec muscle between my chest and left shoulder. The feeling is a tightness or soreness pain that I mainly notice when I breathe in or out deeply, or use the muscles in various ways. However, it does not feel like a muscle pull, and I can't find a place where I can stretch the muscles to feel a pull. The symptoms have stayed the same since two weeks after my second shot in March and have lasted until now. I have not previously had COVID to my knowledge. I do not remember having any medications or events at the time that would have caused these symptoms, and I was not doing anything physical strenuous to have caused this. I got an x-ray that showed no abnormalities. I got an electrocardiogram and an echocardiogram. I met with a cardiologist who evaluated those tests and told me that I had no abnormalities that he thought would cause my symptoms. He along with my primary care nurse practitioner suggested that my symptoms could be from the vaccine and said that I should report this to you.
Within a day of the shot I started to develop a burning sensation on the right side of my body.  Within 2 days of the initial vaccine I developed a rash on my right leg.  It became more painful and developed blisters by 3/13/2021.  I had burning on the inside of my leg and on the right side of my body but no other area of breakout.  I was out of town, but cut my trip early to go to a physician.   I went to the doctor on Tuesday, March 16th, the diagnosis of Shingles was confirmed at the time.  No medication was given as it was already outside of the acceptable "window" for treatment.  I used topical treatment, I continue to have scarring to this date.
There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included Smoker. Concurrent medical conditions included Diabetes, Hypertension and Hypercholesterolemia. Concomitant products included METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET), INSULIN GLARGINE (BASAGLAR), AMLODIPINE and LOVASTATIN for an unknown indication.    On 17-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on). On 17-Sep-2021, EXPIRED PRODUCT ADMINISTERED (There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on) to be not related.    Treatment details were not given.
I got my flu shot on November 5, 2020. FLUZONE QUAD 2020-2021 VIAL SUSPENSION I have been sick since the day after, feels like a head cold. I am so tired my nose is stuffy then I get headaches. I can seem to have enough energy to get through the day. I got tested for Covid and tested negative. Will this feeling go away or do I have to see a doctor? Please advice do I need to go see a doctor?
Patient reported redness, itching, swelling and mild pain at the injection site. Followed up on the next day and she mentioned she was improving. Administered on 12/7/18 by another pharmacist. I received call on Saturday and informed the patient to take OTC BENADRYL and Ibuprofen (or NSAID) for a few days to help fever and her symptoms of redness, swelling, and pain at injection site. I also recommended to the patient to contact her primary care provider if her condition doesn't improve and still follow-up with her physician. Followed up on Sunday with patient and she mentioned that she was improving as the swelling and pain had decreased.
fatigue; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue) 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 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). On an unknown date, the patient experienced FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 09-Feb-2021, PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 test negative: negative (Negative) negative.      No relevant concomitant medications reported.
Information has been received from an office nurse concerning a patient who on an unspecified date was vaccinated with varicella virus vaccine live (Oka/Merck) (lot# 658586/1272U). In January 2008, the patient experienced cellulitis at the injection site on the thigh. It was indicated that the patient also experienced stiffness of the leg. The patient was treated with antibiotic (therapy unspecified). On an unspecified date the patient recovered. A product quality complaint was not reported. This is one of three reports from the same source. Additional information has been requested.
Phone call attempted 9/20/2004 at 10:30am. Left message on answering machine. Phone call attempted 9/20/2004 at 11:30am no answer.
Redness, swelling, pain, and itching to an area 14 cm distal the insertion site and 7 cm at the widest portion on pt's right upper arm. Pt recommended to take Benadryl, Ibuprofen, and to use ice packs on the site. Also, given the option to use topical Hydrocortisone if the Benadril and Ibuprofen did not seem to help.
Woke up morning after Anthrax vaccine and my left arm and under arm area were numb and a rash had formed along lymph node area. Shot received in left arm. Also a golf ball size lump.
Administered an expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 7P2Y3, expiry date 08-APR-2023) for prophylaxis.   On 21-APR-2023, the patient received the 2nd dose of Pediarix. On 21-APR-2023, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: Administered an expired dose). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 21-APR-2023 The nurse reported that she administered a dose of Pediarix which had expired. That was the patient's second dose in the series. At the time of reporting, the dose was not been repeated. The Vaccine Administration Facility was the same as Primary Reporter She did not had the facility street address available at time of call. The reporter consented to follow up. The patient was administered with expired vaccine which led to Expired vaccine used.