chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ulcerative colitis; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (Ulcerative colitis) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Urticaria and Hypersensitivity reaction. Concurrent medical conditions included Asthma, Penicillin allergy (Rash), Sulfonamide allergy (Sulfa- rash.), Drug allergy (Cefdinir- wekts), Allergy to antibiotic (Moxifloxacin-rash), Diverticulitis since 2018 and Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, MULTIVITAMIN ACTIVE WOMAN for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COLITIS ULCERATIVE (Ulcerative colitis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 04-Apr-2021 due to COLITIS ULCERATIVE. The patient was treated with MESALAZINE (PENTASA) ongoing from May 2021 for Ulcerative colitis, at an unspecified dose and frequency. At the time of the report, COLITIS ULCERATIVE (Ulcerative colitis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-May-2021, Colonoscopy: abnormal (abnormal) Ulcerative colitis.         The GI doctor ordered a colonoscopy on 23-May-2021 and the patient was diagnosed with ulcerative colitis, as a result of adverse reaction to Moderna vaccine. The patient was prescribed Pentasa, but it did not relieve the symptoms. Following the second dose of Moderna, the ulcerative colitis worsened. On 02-Apr-2021, patient went to ER and was admitted on 04-Apr-2021 and spent five and half weeks there. The patient had three blood transfusions. Two infusions of a biologic were given, but did not help. The patient had two more colonoscopies and it was determined that she need ileostomy surgery.  Additional treatment information included an antibiotic (unspecified) for a rash and intravenous steroids.  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.     This case was linked to MOD-2021-037198 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Additional follow-up contains non-signification information.; 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.
This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown demographics. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored dose of GARDASIL 9 (lot# M036059, expiry date: 03-JUN-2019) (dosing details were not reported) for prophylaxis (incorrect product storage). Information regarding prior excursions was unknown. Temperature/Time Frame as follow: 32 Fahrenheit (F) to 35 F and 47 F to 77 F for 345 hours over a 90 day period. Call was not because of data logger. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA001551: US-009507513-1705USA001549: US-009507513-1705USA001550.
MMR, DTAP, IPV and Hep-A administered at 14:00 on 6/12/06 and nurse noted redness on L thigh. 6/12/06 (19:00)-6 inch diameter red, warm induration noted. 6/14/06-non-tender.
It started out just as a an aching and a stiffness primarily in my muscles but then into my joints, this progressed for the next two days then diminished after that. This was primarily in my upper body.
Varicella vaccine given at 11:30am on 7/10/2019. Patient waited 15 minutes after injection so we could monitor for adverse reactions. At 11:45am she stated her arm was really itchy. Upon evaluation her arm was red and hot to touch. She was given Benadryl 25mg & a ice pack. By 12:00pm she felt relief.
VACCINE ADMINISTRATION ERROR DUE TO AGE . NO ADVERSE EVENT AT CLINIC OR FOLLOW UP CARE
1/23 /21: Swollen and painful lymph nodes in left armpit and neck 1/24/21: Same as above 1/25/21: Same as above  and swelling  near injection site. Left arm near injection site also became red and itchy.  1/25/21: Same as above with patches of itchy redness on face
Ringing in my ears; This spontaneous case was reported by a nurse and describes the occurrence of TINNITUS (Ringing in my ears) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 025A21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (Codeine).   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TINNITUS (Ringing in my ears). At the time of the report, TINNITUS (Ringing in my ears) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's race was given as private. On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, batch lot number 029X21A, left arm.  On 25-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, batch lot number 049L21A, left arm.  Concomitant medication list was not provided. No treatment was received for the event. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  The patient was treated with a Pfizer product for COVID-19 from 02-Jun-2022 to 07-Jun-2022.
This spontaneous report as received from a physician via a company representative and a pharmacist who was informed by the physician refers to a 69 year old female patient. On 03-DEC-2013, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # J010654, expire date: 17-OCT-2014) injection, 0.5 ml, subcutaneous. On 03-DEC-2013, the patient experienced her arm swelled up, within a few hours, after receiving PNEUMOVAX 23. The patient sought medical attention by visiting the physician, who was also the patient's husband. Prednisone (manufacturer unknown) and BENADRYL were given to treat the adverse event. The outcome of the event was unknown. Additional information has been requested.
Dizziness on day of vaccine, 10/25/06 and also today. Muscle cramping evening of 10/26/06 and also today, lasted 90 min, today x 15 min heat, analgesic helped.
rash under armpits; it was my back went out; This is a spontaneous report from a contactable consumer. This 42-year-old  non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: Unknown), dose 1, administered in Arm Left on 05Feb2021 08:00 PM as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other vaccines within 4 weeks. On 05Feb2021, After going home and rest around 8 pm, the patient could not get out of sofa , her back went out and she had to crawl to bed and lay flat until Sunday. Then patient felt little better and then she had a rash under armpits.The patient underwent lab tests and procedures which included Nasal Swab: Positive on 18Feb2021. The patient did not receive any treatment for adverse event. The clinical outcome of the events was recovered.  Information on lot number/batch number has been requested.
I started just really hurting all over. Severe muscle aches, got up to 101.3 Fever and a really bad headache. I was also really tired, I was mostly worried about the fever which is why I called. I called a work medical line and was recommended to take Ibuprofen  which kept the fever in check. Didn't go away but kept it down. I got lots of rest and sleep and it got better in about 36 hours.
Information has been received from a physician concerning a female who on 02-AUG-2007 was vaccinated 0.5mL, IM with GARDASIL (Lot# not reported). Concomitant therapy included MENACTRA (lot# not reported). Following her vaccination the patient experienced flu like symptoms and mood swings. Subsequently, the patient recovered from flu like symptoms and mood swings. The patient sought unspecified medical attention at her physician's office. Additional information has been requested.
warmth; itchy; ache; redness; chills; Headache; Fatigue; Sore arm; Running nose; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Running nose), INJECTION SITE WARMTH (warmth), VACCINATION SITE PRURITUS (itchy), MYALGIA (ache) and VACCINATION SITE ERYTHEMA (redness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no historical condition was reported). Concomitant products included PARACETAMOL (TYLENOL) and ARNICA EXTRACT for an unknown indication.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced RHINORRHOEA (Running nose), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Sore arm). On 25-Jan-2021, the patient experienced INJECTION SITE WARMTH (warmth), VACCINATION SITE PRURITUS (itchy), MYALGIA (ache), VACCINATION SITE ERYTHEMA (redness), CHILLS (chills) and HEADACHE (Headache). At the time of the report, RHINORRHOEA (Running nose), INJECTION SITE WARMTH (warmth), VACCINATION SITE PRURITUS (itchy), MYALGIA (ache), VACCINATION SITE ERYTHEMA (redness), CHILLS (chills), HEADACHE (Headache), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient took anti viral Paxlovid started on 26Jun2022 and stopped on 30Jun2022. There were no known allergies. There were no other medication in two weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Loss of motion in my left shoulder/ arm. Pain when I raise arm up, back, or to the side. Pain if I lay on that side.  Not able to do any yoga etc.  My son researched it and said I have Servia.
soreness in muscles of left side of neck; Arm soreness; Slight Fever; Had some shivering; This spontaneous case was reported by a patient and describes the occurrence of NECK PAIN (soreness in muscles of left side of neck), PAIN IN EXTREMITY (Arm soreness), PYREXIA (Slight Fever) and CHILLS (Had some shivering) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     Concomitant products included CELECOXIB (CELEBREX) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced NECK PAIN (soreness in muscles of left side of neck), PAIN IN EXTREMITY (Arm soreness), PYREXIA (Slight Fever) and CHILLS (Had some shivering). At the time of the report, NECK PAIN (soreness in muscles of left side of neck) had not resolved and PAIN IN EXTREMITY (Arm soreness), PYREXIA (Slight Fever) and CHILLS (Had some shivering) was resolving.            No treatment information was provided.
Extreme fatigue, body aches, intermittent chills and headaches for 30 hours
dizziness, weight loss, erythema, rash, fever greater than 104, joint pain & swelling, extreme fatigue, chills (4hr long) noc sweats, tachycardia, arthritis, upper resp infect, neuropathy, back pain, high BP, depression, swollen tongue;
pt was found unresponsive. Was hospitalized and kept overnight. Discharged approx 28 hours after admit.
Vaccine that administered beyond use date after the thaw process/expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 28 years 02 months.  Concomitant medication of the patient was not reported. It was unknown if the patient had ever been diagnosed with or tested positive for COVID-19. It was unknown if the patient had any acute illness at the time of vaccination and up to one month before. It was also unknown if the patient had any chronic or long-standing health conditions.  Vaccine Ndc code was reported as 80777-0273-99.  The patient did not experience any adverse reactions after the administration of vaccine.  No treatment information was provided by the reporter.
I felt the normal achiness and swollen lymph nodes, fatigue the day of the vaccine. Later in the day my whole left arm locked up, just as it did after the 2nd dose. And I've had this nerve pain ever since, it's almost as a pinched nerve that starts at the point of injection, down my elbow and up to my neck. I was clammy but without a fever, I was given a muscle relaxer when I went to the emergency room.  I'm currently seeing a neurologist as I'm in a local long COVID unit. I have chronic fatigue. I'm unable to do strenuous activities because of flare ups and on 5 medications right now. Flare ups have been entire whole body aches. This happened when I had Omicron in May 2022 where I went to the ER and they discovered I had COVID. Symptoms included heart rate going off and on, unable to regulate body heat, joint and muscle pain, old prior injuries are painful, fingers and toes get numb. These symptoms lasted for 10-14 days and up until today I'm still dealing with long term COVID-19 symptoms. I'm currently having a flare up right now today. And before COVID-19 and any of the COVID-19 vaccines I never had any flareups. I was quite active going to yoga and running, and now I can't do that any of those things.
This spontaneous report as received from a physician via a pharmacist refers to a patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route, indication and lot number were not reported). No concomitant medications were reported. On an unknown date, after being administered ZOSTAVAX, the patient experienced rash with pustules. The patient called physician's office. The outcome of rash with pustules was unknown. Additional information has been requested.
29JAN92 rash devel in arms, torso, & legs; 4 days prior office visit 25JAN92 dx granuloma annularae; dx papulosa urticaria; hx rash 3-3 1/2 mos not went away resolved a rxn w/lotramin came back 2MAR92;
Ears felt hot for a couple of hours after vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (Ears felt hot for a couple of hours after vaccine administered) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EAR DISCOMFORT (Ears felt hot for a couple of hours after vaccine administered). At the time of the report, EAR DISCOMFORT (Ears felt hot for a couple of hours after vaccine administered) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.
Pt developed a vise-like headache, nausea, photosensitivity, hypotension, shaking rigors and dizziness. Symptoms persisted for 4 hours. Pt was given Benadryl X 2 doses in office. Dx'd with depressed immune system.
There is no adverse event; reporting that patient is 5 days away from 18th birthday, and he received a booster dose [3rd dose]; this 3rd dose would not be indicated based on age for this patient for another 5 days
My father received the zoster/shingles vaccination after starting skin cancer treatment with EFUDIX. He developed chicken pox or disseminated shingles. Fever of 104 degrees F, extremely swollen face with eyes closed, pox on chest, back, arms and legs and hemorrhagic vesicles on face. WBC Ct 33,000. Malaise, insomnia.
allergic reaction with her first dose; all on the left side of her face, inside of her mouth, her cheek area swelled up, and she had immense burning with a red rash on the left side of her face; all on the left side of her face, inside of her mouth, her cheek area swelled up, and she had immense burning with a red rash on the left side of her face; all on the left side of her face, inside of her mouth, her cheek area swelled up, and she had immense burning with a red rash on the left side of her face; 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. The reporter is the patient.  A 61-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2021 (Lot number: ER8733, Expiration Date: 31Jul2021) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "surgery" (unspecified if ongoing); "Bell's Palsy" (unspecified if ongoing), notes: on that left side in the past, 3 years before the vaccine. The patient's concomitant medications were not reported.  The following information was reported: HYPERSENSITIVITY (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "allergic reaction with her first dose"; SWELLING FACE (non-serious), RASH ERYTHEMATOUS (non-serious), BURNING SENSATION (non-serious) all with onset Apr2021, outcome "recovered" (Apr2021) and all described as "all on the left side of her face, inside of her mouth, her cheek area swelled up, and she had immense burning with a red rash on the left side of her face". Therapeutic measures were taken as a result of hypersensitivity, swelling face, rash erythematous, burning sensation.  Additional information: The reaction she experienced was all on the left side of her face, inside of her mouth, her cheek area swelled up, and she had immense burning with a red rash on the left side of her face. She kept drinking water that day to dilute the reaction. It lasted for about 7 hours. Caller was asking if there is anything she should be doing to receive a second dose, she was trying to do the right thing. She went back on 23Apr2021 for her second dose and the vaccination site would not administer the 2nd dose and advised her to talk to her doctor. Patient had surgery and was given the antibiotic Keflex and she experienced a reaction. Patient was asking if the same ingredients are in both, the Pfizer Covid-19 Vaccine and the Keflex.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101400198 similar report from same reporter
Pt lt. arm had a bump that was swollen, red and warm at touch on injection site. Lt. deltoid.
10/23/03 9 PM crying with discomfort. 10/24/03 Fever 100.4 PO; increased discomfort; 25 cent size redness at site, right arm. Redness and fever increased. Seen in ER and admitted. Temp 104 for 48hours. Erythema increased to 20cmx15cm size, warm, tender, decreased ROM. The discharge summary states pain, inflammatory swelling, nausea, and vomiting.
Approx. 1.25 hours after receiving vaccine patient started to experience slight pain left arm. On 7/31/2015 patients left arm was slightly red, swollen, itchy, and warm to touch.  As of 8/3/2015 3:45 all symptoms are starting to resolve.
Patient came into pharmacy with a red arm and thought it was infected. Pharmacist on duty thought it was more likely irritation from the bandage, not an infection.
Fever starting 18 hours after injection (approx 100 degrees). Lasting 36 hours.  Lack of appitite starting 18 hours after injection. Still ongoing after 72 hours. Nausea starting 24 hours after injection. Still ongoing after 64 hours.
Spontaneous Chronic Uticaria started randomly, hives and rashes throughout my body. Itching, burning, throat tightness all started and only has relief with anti-histamines. Dermatographia started as well. Now on daily anti histamines to control reactions. Still occurs daily.