chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The pt took 1st dose oral of Typhoid at 05/25/2002. On 05/27/2002, she took the 2nd dose. On 05/28/2002 at 4am, the pt woke up with itching on face, neck (red, swollen). Also developed very loose stools. On 05/28/2002, called the office and instructed to stop oral typhoid and encourage fluid. Suggested Benadryl. The pt recovered.
Pain in left arm; Patient felt achy; Patient felt a little tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in left arm), PAIN (Patient felt achy) and FATIGUE (Patient felt a little tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy, Allergy to chemicals (Sulfites, even in food), Hypertension (started at age of 25), Asthma (started at age of 30) and Hypothyroidism (started 6 years ago). Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) for Asthma, CHLORTALIDONE (CHLORTHALIDONE) for Diuretic therapy, LEVOTHYROXINE for Hypothyroidism, POTASSIUM and SALMETEROL XINAFOATE (SEREVENT) for an unknown indication.   On 06-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 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in left arm), PAIN (Patient felt achy) and FATIGUE (Patient felt a little tired). On 05-Feb-2021, PAIN (Patient felt achy) and FATIGUE (Patient felt a little tired) had resolved. On 09-Feb-2021, PAIN IN EXTREMITY (Pain in left arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had not taken COVID test. No treatment was given for immediate symptoms after vaccination.   This case was linked to MOD-2022-493586, MOD-2022-493598 (Patient Link).
Induration, redness, swelling and warmth at injection site.  Cellulitis treated with Keflex.
Left knee with four knee surgeries swelled and continues to swell and not bend (month following 2nd dose). Knee feels weak and has impacted the right lower back of the patient.  The patient now has shooting pain up and down her back on the right side as a response to the left knee.
following dose 1 pt's feet started itching, then devel edema feet to thighs, erythema, huge urticarial reaction & discharge of serous fluid from behind knees;
brain fog; chest pain (upper, left side); This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain (upper, left side)) and FEELING ABNORMAL (brain fog) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-2021, the patient experienced CHEST PAIN (chest pain (upper, left side)) and FEELING ABNORMAL (brain fog). At the time of the report, CHEST PAIN (chest pain (upper, left side)) and FEELING ABNORMAL (brain fog) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered CHEST PAIN (chest pain (upper, left side)) and FEELING ABNORMAL (brain fog) to be possibly related.    No concomitant medication information was reported. No treatment medication information was reported. This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain (upper, left side)) and FEELING ABNORMAL (brain fog) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-2021, the patient experienced CHEST PAIN (chest pain (upper, left side)). On 12-Aug-2021, the patient experienced FEELING ABNORMAL (brain fog). At the time of the report, CHEST PAIN (chest pain (upper, left side)) and FEELING ABNORMAL (brain fog) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered CHEST PAIN (chest pain (upper, left side)) and FEELING ABNORMAL (brain fog) to be possibly related.    No concomitant medication information was reported. No treatment medication information was reported.
According to the parents the arm started swelling 2 hours after it was given. They gave Benadryl and Tylenol. The following day they starting placing cold compresses. On Sunday morning the child woke to find his entire right arm swollen to the wrist, the swelling extended over the right side of the chest to the sternum, it extended down the right flank to his waist and extending to the right buttocks. They presented to the ER at 8:30 AM. There he had this extensive swelling which was pink, hot and the skin was tense. He complained of little pain, never had any problem breathing. Restricted movement of his arm because of swelling of the arm. Finger were pink always FROM. He looked he had right sided hemihypertrophy. Upon arrival he was given epinephrine SC 0.5mg, IV hydrocortisone 50mg and PO Benadryl 12.5mg. His vitals signs were always stable and within normal limits. Patient was sent home on Tylenol, Benadryl and prednilasone. Parents were also instructed to give warm compresses alternating with cold compresses. Patient call in AM about 24 hours later and parents reported that the swelling had gone markedly.
p/vax pt presented w/V; treated symptomatically for presumed viral gastroenteritis;5/22 V & stools w/bloody mucous;adm to hosp for hydration;persistent vomiting & bloody stools; intussusception reduced w/ air contrast enema;
No additional AE; 17month old moved when receiving VARIVAX and did not get the full dose. MIR on case: 02392526. No additional AE/No PQC.; This spontaneous report was received from medical assistant and referred to a 17-month-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.  On 19-MAY-2023, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, anatomical site of injection and route of administration, lot #, expiration date and indication were not provided). The patient moved when receiving varicella virus vaccine live (oka/merck) (VARIVAX) and did not get the full dose (Accidental underdose). No additional adverse event was reported (No adverse event).
Patient describes severe muscle cramping in neck, back and shoulders. Reduced use of left are and flaccid left deltoid muscle. He reports reduced strength in left arm that has only improved a small amount.
felt fine afterwards besides a slight headache Tuesday evening. Began feeling jittery and lethargic Wednesday evening and woke up with blotchy , itchy rash all over my body including a large circular rash around the injection site
Pt had seizure. Provided care and comfort. Made sure pt was better before leaving clinic. Rx: Triple mix for tongue sore.
Neck redness, low oxygenation, chest pain, headache for 10 days, nausea, sweating, weakness.
Presented to the ED with SOB, found to be COVID positive, small PE, patient was started on empiric IV antibiotics, steroid therapy with Decadron, infection Disease consulted, he was also seen by Cardiology due to associated atrial fibrillation with RVR new onset, most likely triggered by pneumonia, patient was started on heparin anticoagulation and later switched to Eliquis with loading dose for 1 week then switch to 5 mg b.i.d.
Patient reported swollen hands and joint pain, severe at first, decreasing by the next day. Swollen hands decreased also by next day.
temperature excursion/ one dose of VARIVAX was administered this morning; This spontaneous report was received from an office manager regarding an unspecified patient of unknown age and gender.  Information n unspecified medical history, concomitant medications, drug reactions, or allergies was not provided. On the morning of 05-OCT-2020, the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection once for prophylaxis (strength, vaccination scheme frequency, route of administration, and anatomical location of vaccination were not reported).  The dose had undergone a temperature excursion of 6 to 14 degrees Fahrenheit (F) for 45 minutes as detected by a data logger. There was not a previous temperature excursion. The involved lot numbers were reported as T010312 (expiration date 24-MAR-2022), T000697 (expiration date 07-JAN-2022), and T001311 (expiration date 24-MAR-2022); however, the reporter was not sure which was administered to the patient. Lot number T001311 was determined to be invalid for varicella virus vaccine live.  Follow-up information has been received from the reporting office manager on 22-OCT-2020, stating that the patient was a 12-month-old male. The reporter confirmed the lot number of the administered varicella virus vaccine live (oka/merck) (VARIVAX) was T000697, which underwent an elevated temperature in the freezer.   This case was previously considered non-valid due to the lack of patient identifiers, but upon receipt of follow-up, it was determined to be valid.
Patient came in and said she needed her first dose of Pfizer. After she received the vaccine, it was discovered she already had 2 doses of Pfizer and it has not been 6 months since her second dose.
non-stop pain that goes to left side, in underarm, arm, neck, shoulder, shoulder blade, muscle tendons, ligaments. Feeling of lumps, stiffness, muscle tenderness and muscle spasms, muscle cramping, a type of pressure that makes my arm feel heavy. It has gotten better but still not completely gone, now (7/3/21), I'm feeling numbness in my left arm and hand. My second dose of the vaccine was originally due on 6/12/21, it got postponed to 7/3/21 due to illness but I did not go for it as I'm still not well. Not sure now of when I should get the 2nd dose as it's supposed to be in a certain amount of days after the 1st dose.
She had covid in may 2020 and got covid this year after 3 pfizer shots; She had covid in may 2020 and got covid this year after 3 pfizer shots; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 43-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Codeine, reaction(s): "Allergies: Codeine"; Ibuprofen, reaction(s): "Allergies: Ibuprofen"; Lactose, reaction(s): "Allergies: Lactose"; Norco, reaction(s): "Allergies: Norco"; Vancomycin, reaction(s): "Allergies: Vancomycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She had covid in may 2020 and got covid this year after 3 pfizer shots". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2020) Positive; (19May2022) Positive. Clinical course: patient states she had covid on May 19 and had to stop RA meds for 5 days. Patient states she had sinus pain, headache and fatigue during that time. Doctor aware. Patient also states she had covid in May 2020 and got covid this year after 3 Pfizer shots.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of LOE.
Severe headache with nausea, vomiting, extreme light sensitivity and sound sensitivity. Severe bruising and pain at injection site. Aches, fatigue, malaise. All of the above are still present minus the headache, which eventually resolved.
7x5 cm large local reaction at site of vaccination and fever of 101.5, given prescription Keflex given on 2/1/07-reaction much improved on 2/2/07-redness resolved induration 2x2cm
Tendonitis in my shoulder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, siigle for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TENDONITIS (non-serious), outcome "unknown", described as "Tendonitis in my shoulder". The patient reported that shoulder started bothering him. Doctor indicated that he had tendonitis in shoulder and to get rehab.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
During post vaccine observation time, patient complained of feeling of swelling in mouth and neck. Provider of the day was immediately called to assess patient and 911 was called. Medics arrived approximately 10-15 minutes after call. Medics took over assessment and noted clear lungs, no signs of distress, only noted elevated BP, recommended patient to be evaluated at ER. Patient declined ambulance, signed AMA for medics stating will go to hospital.
Flu symptoms; pain in the arm; This is a spontaneous report from a contactable consumer reporting for her mother.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 27Feb2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient experienced pain in the arm on 27Feb2021, and flu symptoms on 28Feb2021. The outcome of the events pain in the arm and flu symptoms was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021303395 as same reporter/drug, different AE/patients.
Incomplete dose/part of a dose of Arexvy leaked from the needle; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 63-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 7L273) for prophylaxis.   On 21-SEP-2023, the patient received Arexvy. On 21-SEP-2023, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: Incomplete dose/part of a dose of Arexvy leaked from the needle).The outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date:21-Sep-2023 The reporter called to inform that earlier that day, during administration, part of a dose of Arexvy leaked from the needle, which led to incomplete dose administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Site: Swelling at Injection Site-Mild, Additional Details: Patient stated that she has had a small, BB-sized lump in her arm at the injection site since her second vaccination dose, which was a "couple months ago" (administration date given is an estimate as patient did not receive it from our site). She stated it was not painful or uncomfortable.
The pt experienced left thigh induration, triangular formation on thigh with redness over entire area with induration.
Shaking lips & feet appeared blue to mom; pt appeared to have "hard time breathing" when EMS arrived pt appeared OK;
Severe pain in armpit lasting several weeks - Intermittent pain afterwards for month. Abnormal mammogram - enlarged nodes under left arm and lump on left breast.  Injection site was on left arm for Moderna booster shot. I did not speak to my doctor about my suspicion that the vaccine may be the cause of the pain under my arm....but I went to get the mammogram because of my age and because I wanted to rule out that the booster could be the issue.  I plan to discuss with my doctor my experience with the Moderna booster.  I had no lasting side affects with the J&J vaccine.
Alopecia Universalis.    Two months after receiving vaccine, patient experienced extreme hair loss on scalp.  By June 2023, patient was completely bold on scalp and also has complete hair loss on entire body.   Pattern of hair loos - scalp, face and arms, eye brows and lashes, legs and pubic hair.
The patient was nervous about getting the vaccine. As soon as I injected the vaccine, she stated it felt like fire in her arm. Within a few minutes, she stated she felt very hot and she started hyperventilating. I called 911 and tried to assist with her breathing. When the paramedics arrived, they took her blood pressure. Since her blood pressure was very elevated, they transported her to the hospital.
PATIENT GIVEN THE VACCINE TOO EARLY. SECOND DOSE NOT DUE UNTIL 10/19/2021
Angioedema & SkinRash rash - leg and armpit, angioedema - hand and lip
patient reports burning pain in armpit and collar bone area of left arm. He also reports limited range of motion due to the pain. It started 2 to 3 days after the vaccination and has stayed the same (neither increase or decreased in severity)
localized swelling, redness, warm to touch to inj site where hep B recv;tx warm compresses & duricef;
Patient developed shingles approximately 1 month after immunization.  She was treated with acyclovir.  A viral culture collected early in her illness course confirmed the presence of varicella zoster virus.  She had an uneventful recovery.
1. Dizzyness (dose 2) 2. Low Fever (dose 2) 3. Muscle ache (dose 2) 4. Not able to lift left arm 5. Headache 6. Armpit swollen with minor pain 7. Tiredness
Patient had a spike in blood pressure (per Epic BP was at 153/84 at ED) starting the next early morning after receiving vaccine as well as fever (100.6 F at ED). She went to ED for these symptoms and nausea, myalgia and headache.Provider that she saw was unable to find any other reason other than possibly the vaccine. Patient was not admitted.
Severe overall itching and front and back torso pain. It was painful when she put covers on in bed. Patient took po Benadryl 25mg at noon and at 6PM on 07/18/2010. Pain gone on 7/19/2010 and itching relieved 80%. As of 7/20/2010, itching was totally gone.
Very strong headaches and high blood pressure for two weeks. Went to the hospital twice in that span of time. Monday May 10, he couldn?t see through his right eyes. He went to the ER and they found a blood clot in his artery(thrombosis) and that night had a stroke in the brain. Still at hospital.
Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a  patient of an unknown age and 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 an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.            No concomitant products reported.  Patient wanted to know if the event was life threatening.  No treatment products reported.
Report Adverse Event; vaccine administration past expiration date; This spontaneous case was reported by a nurse and describes the occurrence of IMMUNISATION REACTION (Report Adverse Event) and EXPIRED PRODUCT ADMINISTERED (vaccine administration past expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Report Adverse Event) and EXPIRED PRODUCT ADMINISTERED (vaccine administration past expiration date). At the time of the report, IMMUNISATION REACTION (Report Adverse Event) and EXPIRED PRODUCT ADMINISTERED (vaccine administration past expiration date) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.    No treatment information was reported.
Swollen lymph node in collar bone started 4 to 5 days after first injection.  Seemed to partially resolve after a week, but after second shot was swollen again.  Still remains palpable 6.5 weeks after second shot.
Pain at injection site; Nausea; Tiredness; Metallic taste in mouth; This is a spontaneous report received from a contactable nurse. The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162B2 (BNT162B2), intramuscular, administered in arm left, administration date 20Apr2021 10:45 (Lot number: EW0158) at the age of 62 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing). Concomitant medications included: VALACYCLOVIR [VALACICLOVIR]; MONTELUKAST; CITALOPRAM. Vaccination history included: BNT162B2 (DOSE 1; Lot Number: ER2613; 10:45 AM; intramuscular in left leg), administration date: 30Mar2021, when the patient was 61 years old, for COVID-19 immunization, reactions: "Pain at injection site", "Administered intramuscularly in left leg". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 20Apr2021 23:45, outcome "not recovered", described as "Pain at injection site"; NAUSEA (non-serious) with onset 20Apr2021 23:45, outcome "not recovered", described as "Nausea"; FATIGUE (non-serious) with onset 20Apr2021 23:45, outcome "not recovered", described as "Tiredness"; DYSGEUSIA (non-serious) with onset 20Apr2021 23:45, outcome "not recovered", described as "Metallic taste in mouth". Therapeutic measures were not taken as a result of vaccination site pain, nausea, fatigue, dysgeusia.  Additional Information: The patient was not diagnosed with COVID-19 prior vaccination. The patient was not administered with other vaccine in four weeks. Adverse events were after around 12 hours of injection of the second dose. The patient has not been tested for COVID-19 post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021455566 Same reporter, patient, and product; different events and dose
Received An Expired Dose of Heplisav-B; Initial Report Received on 07-Sep-2022  A compliance/privacy officer and quality improvement director at a doctor's office reported that a 52-year-old female patient (race and ethnicity unknown) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history, concomitant medications, and allergies at the time of vaccination were not reported.  On 07-Sep-2022, the patient received an expired dose of HEPLISAV-B (Lot # 934975, expiration date 13-Aug-2022, NDC # 43528-003-05, route not reported) in the right arm.    No further information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
pt c/o feeling dizzy , tingling in upper and lower extremities. Developed a headache while EMS assessed her  BP 151/105 Glucose 106 . Transported to Hospital