chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain at the injection sites; This is a spontaneous report from a contactable other hcp. A 55-years-old female patient received BNT162B2 (Formulation: Solution for injection; Batch/Lot Number: EL3248, dose 1 intramuscular, administered in Arm Left on 09Jan2021 09:00 (Batch/Lot Number: EL3248) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included allergy to Pine Nuts, Sunflower seeds from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin (ATORVASTATIN), fish oil (OMEGA 3 [FISH OIL]), zinc (ZINC), (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication, start and stop date were not reported; vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), vitamins nos (VITAMINS NOS) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date of on Jan2021 patient experienced with the 1st and 2nd vaccine there was pain at the injection sites. The patient received treatment with Advil. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Itching started 01/13/2021 on left arm axillary area. Rash appeared 01/14/2021 to bilateral armpits, bilateral antecubital areas, chest, below breasts, groin, bilateral wrists.  Rash was blotchy and extremely itchy. Rash worsened and peaked on 01/17/2021. Rash is slowly going away
Report received from a PharmD student on 22-OCT-2009. A male (date of birth not provided) received AFLURIA IM on 23-SEP-2009. He had a medical history of insulin dependent diabetes mellitus (IDDM). On the same day, concomitant therapy was switched from regular insulin to LEVEMIR. On 05-OCT-2009, the patient's wife reported her husband was experiencing hallucinations. On 06-OCT-2009, the patient was seen in the clinic. His diagnoses included acute renal failure and hallucinations. At the time of reporting, the patient had recovered from hallucinations and was recovering from acute renal failure. Conflicting information had been reported by another PharmD student who noted that the patient signed out against medical advice (AMA) and was scheduled to follow-up with the Clinic. Additional information has been requested.
Burning hot; Itchy; Welted up; tender; Egg shaped spot, nos is beige colored and still there; Sore arm; Really tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (Burning hot), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE INDURATION (Welted up) and FATIGUE (Really tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ASCORBIC ACID, VACCINIUM MACROCARPON (CRANBERRY [ASCORBIC ACID;VACCINIUM MACROCARPON]), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and VITAMIN B COMPOUND [CALCIUM PANTOTHENATE;CYANOCOBALAMIN;ERGOCALCIFEROL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE] for Supplementation therapy, LOSARTAN, PROGESTERONE, ESTRADIOL (E2), ESCITALOPRAM OXALATE (LEXAPRO) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Really tired). On 22-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Burning hot), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE INDURATION (Welted up), VACCINATION SITE PAIN (tender) and VACCINATION SITE LYMPHADENOPATHY (Egg shaped spot, nos is beige colored and still there). The patient was treated with PARACETAMOL (TYLENOL) on 15-Jan-2021 for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE for Adverse event, at an unspecified dose and frequency and CORTISONE for Adverse event, at an unspecified dose and frequency. On 16-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved, FATIGUE (Really tired) was resolving. On 25-Jan-2021, VACCINATION SITE WARMTH (Burning hot), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE INDURATION (Welted up) and VACCINATION SITE PAIN (tender) had resolved. At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Egg shaped spot, nos is beige colored and still there) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medications included: turmeric. Additional event treatment included: cryotherapy.
Pt c/o not feeling well; pt skin was pale and was diaphoretic.  RN at side; assisted to lay down with legs raised on chair.  Also, EMT at side.  Pt. A&Ox3, speech clear and appropriate.  VS: 1510: HR 122, SpO2 97% laying down.  Pt. admitted to only eating a banana today and not much fluids.  Pt. reported feeling better and assisted to chair.  VS: 1515:% HR 59 SpO2 99% RA, SBP 84.  Pt. given juice, water and crackers which she tolerated.  Pt. reported feeling improved but a little shaky; color improved.  VS: 1520: HR: 74, SpO2 99% RA, BP: 98/62.  Pt continued to sit in chair and monitored.  Pt. reported feeling better and able to go home.  Pt. was d/c at 1550.
Administration of an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 009C21A and 048B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 04-Dec-2020.   On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that reporter doesn´t know if the patients are on any concomitant medication. It was reported that vaccine was expired for three days and had not undergone any temperature excursions. The patients didn´t have any allergies, acute or chronic illnesses at the time of vaccination, and no other vaccines were administered 1 month prior to Moderna Covid-19 Vaccine. The patient had no symptoms after receiving the expired dose. No treatment details were reported.   This case was linked to MOD-2022-521598, MOD-2022-521636, MOD-2022-521490 (Patient Link).
covid arm; I had  feeling swelling at the injection site; swelling at the injection site, covid arm, redness and itching; swelling at the injection site, covid arm, redness and itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (covid arm), VACCINATION SITE SWELLING (I had  feeling swelling at the injection site), VACCINATION SITE ERYTHEMA (swelling at the injection site, covid arm, redness and itching) and VACCINATION SITE PRURITUS (swelling at the injection site, covid arm, redness and itching) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 019B21A and 013A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and CLONIDINE HYDROCHLORIDE (CATAPRES TTS) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (covid arm), VACCINATION SITE SWELLING (I had  feeling swelling at the injection site), VACCINATION SITE ERYTHEMA (swelling at the injection site, covid arm, redness and itching) and VACCINATION SITE PRURITUS (swelling at the injection site, covid arm, redness and itching). At the time of the report, VACCINATION SITE REACTION (covid arm), VACCINATION SITE SWELLING (I had  feeling swelling at the injection site), VACCINATION SITE ERYTHEMA (swelling at the injection site, covid arm, redness and itching) and VACCINATION SITE PRURITUS (swelling at the injection site, covid arm, redness and itching) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment medications were not provided.
This spontaneous report as received from a medical assistant, refers to a currently 1 year old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an improperly stored M-M-R II, (which had a lot # of N014486 and an expiration date of 10-MAY-2019; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion since an unknown date: 49 F for 9 days. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1808USA006354:
Kinrix given, then Proquad.  As soon as Proquad was given, He developed a large welt next to injection site. Dr. informed and Benadryl given with good effect.  Parents advised to wait in waiting room for 20 mins.
Patient reports twitching in legs, GI issues including significant diarrhea, tingling and cramping in the feet
occasional headaches since corona vaccine 2 weeks ago; This is a spontaneous report from a non-contactable consumer via Pfizer-sponsored program. A 81-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included diarrhoea from Nov2020, alopecia from Nov2020. Concomitant medication included palbociclib (IBRANCE), oral from 2020 to an unspecified date, at 75 mg, cyclic (21 days on/ 7 days off) for breast cancer, letrozole taken for an unspecified indication, start and stop date were not reported. The patient reports before and after start of therapy diarrhea off and on. hair thinning. occasional headaches since corona vaccine 2 weeks ago on an unknown date. md thinks ibrance is working. advised to inform md. The action taken in response to the event for bnt162b2 was not applicable and palbociclib was unknown. The outcome of the event was unknown.  No Follow-up attempts are needed. No further information is expected.
Information has been received from a pharmacy intern referring to a patient of unknown age and gender. On 06-SEP-2016 the patient was vaccinated with expired PNEUMOVAX 23 lot # L002310 (expiration date 08-JUL-2016). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax 31JAN97 & on 22FEB97 pt exp rash w/ 8 to 20 lesions which began on lt arm 7 @ the time of report were on head & other areas of body;
It began as what appeared to be bug bites on my chest and about ten days later, I saw my PCP, because it looked like psoriasis. It was on my chest, back, neck and face. He did not know what it was and wondered if it was connected to the vaccine. It was the only change that had happened in my life. He put me on 50mg per day for five days of prednisone. That didn't seem to help at all. It actually seemed to become worse. He gave me more prednisone. The dosage went from 50mg for 2 days, 40mg for 2 days, 30 mg for 2 days, 20mg for 2 day and 10mg for 2 days. That did not help either. By now, we are three weeks into it. I saw a dermatologist on 12/02/2021. The dermatologist told me that he was almost certain that it was a reaction to the booster. The psoriasis is beginning to fade. He gave me a topical cream that I apply twice a day. In the meantime, I have developed what looks like a sunburn on my arms and a little on the tops of my legs. I sent pictures to the doctor and he feels that it's an immune overreaction to the vaccine. The redness on my arms looks like it's beginning to fade, but my skin is now very dry. I do see the dermatologist again on 12/16 for a follow-up.
received her second Moderna COVID-19 vaccine in incorrect amount; received her second Moderna COVID-19 vaccine in incorrect amount and in double dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (received her second Moderna COVID-19 vaccine in incorrect amount) and EXTRA DOSE ADMINISTERED (received her second Moderna COVID-19 vaccine in incorrect amount and in double dose) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (received her second Moderna COVID-19 vaccine in incorrect amount) and EXTRA DOSE ADMINISTERED (received her second Moderna COVID-19 vaccine in incorrect amount and in double dose). At the time of the report, INCORRECT DOSE ADMINISTERED (received her second Moderna COVID-19 vaccine in incorrect amount) and EXTRA DOSE ADMINISTERED (received her second Moderna COVID-19 vaccine in incorrect amount and in double dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.
Short (1-3 second) muscle contractions in opposite shoulder of injection site and in opposite posterior muscle (near the scapula); Drowsiness; Confusion; unclear cognitive function; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration on 15Apr2021 at 17:15 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, it was unknown whether the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, the patient experienced short (1-3 second) muscle contractions in the opposite shoulder of injection site and short contractions in the opposite posterior muscle (near the scapula); the patient also experienced some drowsiness and confusion (unclear cognitive function). Therapeutic measures were not taken as a result of the events. The clinical outcome of the events short muscle contractions in the opposite shoulder of injection site and in the opposite posterior muscle (near the scapula), drowsiness and confusion (unclear cognitive function) were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
MDA5 Dermatomyositisn with Rapidly Progressing Interstitial Lung Disease
Fatigue, Diarrhea, Headache with head pressure, Numbness on left side of face, Chest pressure, Abnormal heart rhythm, Loss of peripheral vision on left eye
administrated with an expired dose of Bexsero; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 22nd January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd March 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 2nd March 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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 details were provided as follows: The age at vaccination was not reported. The patient was administrated with an expired dose of Bexsero, which led to expired vaccine used.  No adverse event was reported. No patient's identifiers and lot number were provided. The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter.
On February 7, 2023, I developed upper respiratory symptoms. I tested for COVID-19, but I was negative. On February 8, 2023, I began using the inhaler SYMBICORT due to my reactive airway. I retested for COVID-19 on February 9, 2022. The result was still negative. The symptoms improved over that weekend. I began to feel sicker on February 13, 2023. On February 16, 2023, I was suspicious that I had pneumonia. I saw an urgent care doctor on February 17, 2023. I was coughing significantly and mildly short of breath. I also had a fever of 101-degrees. My oxygen was 91. They performed a Chest X-Ray which showed early Pneumonia. I received prescriptions for AUGMENTIN and a Z-PAK. I began improving significantly within a couple of days. I had a follow-up on February 22, 2023, with my Primary Care Physician and was feeling much better. By February 25, 2023, I felt normal.
severe arm pain and stiffness and difficulty moving arm which lasted four days. At time of completing this form (Sunday) still experiencing arm pain with plans to call family doctor on Monday if not any better. headache, chills, muscle pain, diarrhea, nausea 24 hours. Tiredness for two days.
I gotten the first does in April then the second dose in March. The first dies cause my knees muscles to atrophy so I very weak knees so I have hard time standing up, and I been having frequent headaches. and having some heart discomfort.
Left arm, left eye/face numbness (front teeth and cheek numb) and some lightheadedness. Vitals: 02 sat 98% on RA, BP 122/70, HR 60. No rash, itchiness or wheezing. Throat/neck/thorax clear. Patient given 25 mg PO Benadryl and 20 mg PO famotidine.
Patient started having symptoms within 48 hours of receiving the vaccine. The first night it started as pressure in the chest/heart and was able to fall asleep but then was woken back up to more of a sharp "stabbing" in the same area. This persisted for roughly 3 weeks with approximately 5 episodes during this time. Each episode did seem to be less painful. The last episode was around the 31st of march.
Extreme upper abdominal and mid back pain. Ultrasound obtained showing gall stones and inflammation of the gallbladder, admitted to Hospital for emergency laparoscopic cholecystectomy to remove gallbladder
"Moderna COVID-19 Vaccine EUA"  Emergency room visit for weakness and dizziness,
This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program COVAX US Support. A 85-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 27Feb2021 (Lot Number: EN6205) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient mentioned that she had slept for 3 days and she was sleeping a lot after she got the first dose in 2021, then a day before reporting on 03Mar2021 she was soaking wet and must have had a fever. This had never happened to her before. She was feeling kind of rotten for the past few days in 2021 and she wanted to know was that normal. On the day of reporting she felt like she was going to make it. She was scared to get the second COVID vaccine. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Patient c/o shortness of breath and "throat closing up"after receiving Covid vaccine at 10:00am..  O2 started at 4l/min via n/c at 10:10am. , BP taken and advised to administer her Epi pen that she had with her due to allergy to Gelatin, administered Left thigh by patient.at 10:15am. 911 called at 10:20am.   BP 152/93 HR 80 at 10:25am, 154/105 HR 75 at 10:27am, 148/92 HR 75 at 10:30 when departed to Medical Center. 02 sat remained at 99%.  Skin warm and dry and remained alert through out process.
heavy period/had never seen a period heavy like that before/it's coming like a storm for three days; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (heavy period/had never seen a period heavy like that before/it's coming like a storm for three days) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025120A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (heavy period/had never seen a period heavy like that before/it's coming like a storm for three days). At the time of the report, HEAVY MENSTRUAL BLEEDING (heavy period/had never seen a period heavy like that before/it's coming like a storm for three days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported like a storm for three days.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.     Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Non-Significant FU; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.