chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left arm hurts on movement and when rolls over at nights, long after second shot/Painful to raise the left arm  long after second shot; Swelling on the injection site came back long after second shot; Swelling on the injection site (Softball Size) after second shot; Red injection site after second shot; Fever 102.3 F after second shot; Warm to the touch injection site after second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch injection site after second shot), VACCINATION SITE PAIN (Left arm hurts on movement and when rolls over at nights, long after second shot/Painful to raise the left arm  long after second shot), INJECTION SITE SWELLING (Swelling on the injection site came back long after second shot), VACCINATION SITE SWELLING (Swelling on the injection site (Softball Size) after second shot) and VACCINATION SITE ERYTHEMA (Red injection site after second shot) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch injection site after second shot), VACCINATION SITE SWELLING (Swelling on the injection site (Softball Size) after second shot), VACCINATION SITE ERYTHEMA (Red injection site after second shot) and PYREXIA (Fever 102.3 F after second shot). On 20-Jul-2021, the patient experienced VACCINATION SITE PAIN (Left arm hurts on movement and when rolls over at nights, long after second shot/Painful to raise the left arm  long after second shot) and INJECTION SITE SWELLING (Swelling on the injection site came back long after second shot). On 30-Apr-2021, VACCINATION SITE WARMTH (Warm to the touch injection site after second shot), VACCINATION SITE SWELLING (Swelling on the injection site (Softball Size) after second shot), VACCINATION SITE ERYTHEMA (Red injection site after second shot) and PYREXIA (Fever 102.3 F after second shot) had resolved. At the time of the report, VACCINATION SITE PAIN (Left arm hurts on movement and when rolls over at nights, long after second shot/Painful to raise the left arm  long after second shot) and INJECTION SITE SWELLING (Swelling on the injection site came back long after second shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.3 (High) High.         No concomitant medication was reported  No treatment medication was reported
soreness @ site; tenderness @ site; dec mobility in joint; on ATB & pain medication receiving PT treatments;
Almost immediately, sore injection site, later becoming sore shoulder muscle. Around 10 pm began feeling like onset of flu. Woke up around 3 am with temperature of 98, chills, cramps, muscle ache, headache. Temperature rose to 99.1 around 4 am. Woke up around 7 am still feeling same. Temp at 98.8 as of 8:45 pm.
Likely serum sickness. Fever, body aches, headache vomiting, dehydration, leukopenia, elevated liver function tests.
RED CIRCULAR RASH AND LUMP UNDER SKIN.  SKIN IS VERY ITCHY
Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 17 years old male patient who received 0.5 ml third dose of vaccine MENACTRA (lot U6204AA) via intramuscular route in the left deltoid instead of vaccine TRUMENBA on 12-Nov-2018. It was reported that, on the same day, the patient also received a 0.5 ml dose of vaccine FLUZONE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered and extra dose administered. It was not reported if patients had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
deep thrombosis on both of her legs; "made her nerve shot"; diarrhea; can see but little hard to read small prints; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm in Apr2021 (batch/lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. Caller (patient) said that she was on a blood thinner and has been for 2 years and they never mentioned anything about it when they gave her the vaccine. On her first shot of bnt162b2, she experienced increased heart rate (reached 133) and stomach ache. Caller also stated that her arm went sore but was not indicated whether it was on her first or second shot. On her second shot, she experienced deep thrombosis on both of her legs, diarrhea that comes and goes, "can see but little hard to read small prints", "made her nerve shot" in 2021. Patient also wanted to confirm if it would be advisable to administer the vaccine on the other arm if there is a cancer on one arm but did not state if she has this condition. Outcome of events was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Approximately 4 hours after the injection, around 1215, she had suddenly increased HR to 150 bpm and became diaphoretic. She was escorted to the Employee Health Office where her vital signs were checked and she laid down in a dark room. After about 30 minutes she was complaining of ongoing clamminess, mild nausea and some chest discomfort but no difficulty breathing. She was sent home to rest and given instructions for follow up. Vitals: 1240 - BP: 155/91 HR: 119 T: 98.3. 1300 - BP: 138/78 HR: 76
Pt recvd 3rd dose of Hep B vax on 19MAR92; w/in 15 min of receiving vax pt exp dizzy feeling, chest pain, swelling sensation of throat & joint pain; tx steroids & hospitalized;
erythema around injection site, macular rash to abdomen, back, legs, arm,hands
This case was reported by a healthcare professional and described the occurrence of lightheadedness in a 45-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included allergy to eggs and anaphylactic reaction to vaccine. On 14 December 2012 the subject received 3rd dose, 2nd dose and 1st dose of FLUARIX (.15 mL, unknown) and experienced inappropriate dose of vaccine administered and drug use for unapproved indication. On 14 December 2012, immediately after the 2nd vaccination with FLUARIX, the subject experienced lightheadedness. The subject was administered a three dose split series of 0.15 ml (from 0.5ml), the doses were administered every 20 minutes due to experiencing an anaphylactic reaction seven years ago following flu shot. The subject's job requires her to be vaccinated with flu vaccine therefore the three dose split series was administered by the physician. Right after the 2nd dose of FLUARIX the subject felt lightheaded but the series was completed 20 minutes later with the 3rd dose. After the series was completed the subject went home with EPIPEN and ZYRTEC, however, on follow up the subject did not experience any other reactions and did not need to use the EPIPEN or ZYRTEC. The reporting nurse had inquired about what to do since an expired dose of FLUARIX was administered. At the time of reporting the outcome of lightheadedness was unspecified. The healthcare professional refused to provide complete contact information. Please see A1005612B regarding the subject's anaphylactic reaction seven years ago following flu shot.
It is three weeks since I received the first vaccine and am scheduled for the second one in six more days. I am worried that my arm still aches after so many weeks. Don't know which arm I should get the second vaccine in. Everything I read says that the ache should have passed in less than two weeks.
My blood pressure has always been 110/65 and heartbeat at 65. I have experienced rapid-like a-fib heart palpitations since the Pfizer booster in September 2021. My blood pressure is usually now in the 130's/80 area. My resting heartbeat is in the 80's now. I am very athletic for my age. I am on thyroid medication, lowest dose. Otherwise very healthy. I assumed my heart rate was a "one-off" but it continued through Fall of 2021. February of 2022, I got a very mild case of COVID-19. I had no symptoms, but had to take a test prior to going to work. It resolved within five days. My blood pressure and heart rate continue to remain high. May of 2022, I emailed my doctor to maybe try a heart monitor, but I did not pursue the issue. I had a colonoscopy since then and it remained high. They attributed to being in the hospital and remarked, it was perfectly normal. For me it is not.
Narrative:  83yo patient who does not receive medical care from the agency receive covid vaccines from the agency on 3/19/2021 & 4/16/2021. Agency was informed pt died on 9/29/2021. No information available regarding pt's medical history or cause of death. Likely death is unrelated to covid vaccines given pt's advance age and length of time between death and dates covid vaccines were given.
11/11/22 I had a normal cleaning check up with my Dentist. I had a lesion in my mouth that I was unaware of. The dentist said if it did not go away in two weeks, he would send me to an oral surgeon.  After two weeks, it had not gone away so I went to see an Oral Surgeon in December.  They did not think it was anything. In January 2023, I went back to the Oral Surgeon, and they removed the lesion and diagnosed me with Lichen Planus.
SkinRash, CoughWheeze, Rash & UrticariaPruritus Narrative:
Arm was sore; little headache the second day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) and HEADACHE (little headache the second day) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore) and HEADACHE (little headache the second day). At the time of the report, PAIN IN EXTREMITY (Arm was sore) and HEADACHE (little headache the second day) outcome was unknown.            No treatment was mentioned. No Concomitants are mentioned.   This case was linked to MOD-2021-014749 (Patient Link).
Case received from a patient on 30 July 2007.  A 56-year-old female patient with a medical history of asthma, had received an intramuscular right deltoid injection of IMOVAX RABIES vaccine on 25 July 2007, lot number not provided.  The patient reported that within 24 hours after vaccination, she experienced flu-like symptoms, chills, fever, muscle aches and breakage of small blood vessels and bleeding in her extremities.  The patient reported that she had received BENADRYL before vaccination.  This had been the third dose of the rabies post exposure prophylactic series.  The first and second dose of IMOVAX RABIES had been administered on 19 July 2007 and 22 July 2007.  Her medical history included allergies to eggs, dyes and NOVOCAIN.  At the time of this report the patient had not been evaluated by a health care professional and she had not recovered.
Per child's mother statement - hives and itching noted on the face approx 3-4 hours after administration of Hepatitis A and PPD on 6/6/03. No fever. Hives noted for 2 days, relieved and hives subsided with Benadryl oral tx.
Redness started (L) thigh increased on 24 hr and worsened in 48 hr, gotten better, no trouble.
Information has been received from a physician concerning a female in her late 70's who in December 2006, was vaccinated with ZOSTAVAX (Oka/Merck) (lot no., route and site of administration were not reported). On 16-JUN-2008 the patient had Shingles; back of neck, rash, no pain. It was reported in follow-up that on 18-JUN-2008 the patient developed rash. The patient did not experience pain or tingling prior to the onset of her rash. On 19-JUN-2008 the physician saw the patient and diagnosed her with Shingles in the C3 dermatome on the right. The patient was not having any pain and was treated with VALTREX. Additional information has been requested.
A reddish rash appeared  approximately 2? x  3.5? that is a little itchy and slight inflammation and hardness in the area of the injection site upper right arm.
received third dose from vial refrigerated for more than 30 days; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter reported that the vaccine was defrosted in 30-Aug-2021. Date the vial was initially stored in the refrigerator was 30-Aug-2021. The reporter stated that it is unknown if patient is immunocompromised.   This case was linked to MOD-2021-358921, MOD-2021-358773 (Patient Link).
Initially had a very sore arm day of, then on the second night my entire body became itchy and I had welts similar to those from allergy shots around my body and the itchyness has lessened however I am still itchy.
I developed a rash  on my right and left arm and on my thighs. I just got a medicated cream.
pt recv vax 12SEP96 & on 24SEP96 pt devel redness, hardness the size of a baseball & nausea;pt recovered from nausea;
Patient came to the ED with altered mental status and lower abdominal pain.  Patient was admitted to the hospital with bacterial pneumonia, delirium, and Covid.  Patient was treated for Covid with remdesivir.
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild
administered with expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported The vials were not stored in the refrigerator and directly thawed them from the freezer before administration. The vial did not undergo any temperature excursions. No treatment medications were reported
rash on forearms 23FEB94 to present; h/a 23FEB94-25FEB94; soreness of lt arms (site of inject( 23FEB to now under lt arm ax soreness 23FEB94-25FEB94 joint pain of entire lt arm 23FEB to present;
Suspected infection after vaccination administered on Monday and spreading past demarcation line but was not discharged on antibiotics. Given clindamycin prescription did improve.
19APR99 pt recv vax & 22APR99 7AM had possible sz;disoriented, confused, foaming of mouth;went to ER via amb;seen by neurologist;observed for 24 hr & discharged;
This spontaneous report as received from a registered pharmacist refers to a 71 years old male patient with no pertinent medical history, drug reactions or allergies. The patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot # not reported) on 11-SEP-2012. No other co-suspects were reported. There were not concomitant medications. It was reported that 4 days ago on 24-SEP-2012, the patient developed nausea and rash after receiving ZOSTAVAX. The patient sought medical attention by contacting the pharmacist and no lab diagnostic tests were performed. No treatment information was reported. The outcome of nausea and rash was reported as not recovered. The relatedness for the reported events was not provided for ZOSTAVAX. Additional information has been requested.
patient had slight, light pink/redness around injection site, approximately 3 inches in circumference. patient stated it is warm to touch, slight stinging/burning with increasing itching as well
I had just had my period on 02/22/21 (first day of the cycle) and then received the first dose of the vaccine the following week (on 03/04/21).  I had a slight period the day after (03/05/21) which lasted about 3 days.  I thought it was just a coincidence and didn't think much of it.  The same issue happened after I got the second dose on 03/26/21; I got my period again.  My period is usually normal (every 27-31 days), so it was definitely strange to me that my period came so soon and both times were immediately the day after the shot.  It was just a normal period with no blood clots or anything abnormal, but I do feel like it's an adverse reaction of my body to the vaccine.
resident received a 2nd dose of covid vaccine today 06/01/2021. resident consented to the medication. No notation in his chart of a previous vaccine. MD and family notified. Resident was was informed of the medication he was about to receive and did not make mention to the nurse that he had it previously.  No adverse effects noted at this time. first dose was 4-2-2021
High Fever 103.1 right within 25 hours of receiving vaccine.  Resolved within 24 hours.  No other symptoms.
Bottom lip is not crooked or nothing like it but inside it is kind of little swelled; Mouth is kind of swollen up; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284, Expiry Date: Apr2021), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. The patient had the COVID shot on Tuesday (29Dec2020) and thinks her mouth is kind of swollen up. Her bottom lip is not crooked or nothing like it but inside it is kind of a little swelled. The patient started experiencing the adverse events in the morning of 31Dec2020. No treatment was administered for the events, and the patient was advised to contact primary healthcare professional. The outcome of the events was unknown.
Hospitalization: 10/17/2022 - 10/24/2022  Presentation to the ED: R HIP FRACTURE.  COVID + date: 10/17/22  Treatment: Decadron & hydrochlorothiazide, SUPPLEMENTAL 02.  Discharge to: REHAB FACILITY.
Pt recvd Hep B vax on 22MAY92 & devel flu-like illness characterized by lethargy, hot flashes & an aching also devel heat-like rash that itched;
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Date the vial was initially stored in the refrigerator was 05-Nov-2021. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.
really bad lower back pain feels like a ton of pressure built up but can't pop it; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (really bad lower back pain feels like a ton of pressure built up but can't pop it) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (really bad lower back pain feels like a ton of pressure built up but can't pop it). At the time of the report, BACK PAIN (really bad lower back pain feels like a ton of pressure built up but can't pop it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
This literature marketed report was received from the authors of the published literature article and refers to a 12 year old female patient. The patient had no significant history of infections and had normal growth (normal height and weight and an occipital frontal circumference on the 25th percentile). Sequencing of the ligase-4 (LIG4) gene revealed two compound heterozygous mutations leading to immunological abnormalities and severe B cell Lymphopenia was observed. On an unknown date, the patient was vaccinated with a dose of tetanus toxoid and had protective titers of antibodies to the vaccine. On an unknown date, she was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route of administration, lot # and expiry date were not reported). Upon immunization, protective antibody responses were detected against only 5 of 23 serotypes. The outcome of antibody response abnormal was unknown. The reporter considered the event to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). This is one of two reports received from the same literature article (cross referenced with MARRS# 1605USA011761). Additional information has been requested.