chrisvoncsefalvay/vaers-outcomes huggingface dataset:
former 25 week premature twin, with a complicated medical history including autism spectrum disorder, chronic lung disease after prematurity, retinopathy of prematurity stage 2 bilaterally, bilateral hearing loss, and g-tube feedings who presents with 4-5 days of increasing cough, increasing sputum production, fevers, and listlessness.  Child was evaluated in a local urgent care, where he was found to be febrile to 102.8F. Oxygen saturations were reported to be 89-90% but improved to 94% on 1L NC. A CXR was obtained with a reported area of concern on the right per verbal report. Direct admission was requested by referring provider. Child was given a dose of dexamethasone 6.5mg.
Tues A.M. - upper arm swollen; as day progressed (L) arm became more swollen and painful (elbow to wrist) called doctor Tues (9/27/11) evening, told take BENADRYL and cool compresses symptoms are abating (9/29/11).
Chills, fever, nausea, aches and pains. Fever of 101 deg F.
Presented to the ED with a chief complaint of LUE pain.  Patient recently received the COVID-19 vaccine and is now experiences some redness, swelling and pain to the area which started about 7 hours after vaccine administration.  Skin is also warm to the touch.  He called his PCP who advised taking antihistamines and icing the area.  Patient received single oral doses of both cephalexin 500 mg and diphenhydramine 25 mg in the ER at 1020 on 1/7/21.
Information has been received from a health professional concerning a 10 year old female, who on 05-MAY-2007 was vaccinated with her second dose of Gardasil vaccine. On 29-OCT-2007, the patient received her third dose of Gardasil vaccine (lot number 658488/1264U). There was no concomitant medication. On 28-OCT-2007, the patient experienced cellulitis on her right forearm. The patient sought medical treatment with an office visit. Benadryl was prescribed and the patient was given a prescription for antibiotics to fill if the adverse experience worsened. Additional information has been requested.
fatigue, nausea, body aches, headaches, flu like symptoms and itchiness in the injection site; fatigue, nausea, body aches, headaches, flu like symptoms and itchiness in the injection site; fatigue, nausea, body aches, headaches, flu like symptoms and itchiness in the injection site; fatigue, nausea, body aches, headaches, flu like symptoms and itchiness in the injection site; fatigue, nausea, body aches, headaches, flu like symptoms and itchiness in the injection site; fatigue, nausea, body aches, headaches, flu like symptoms and itchiness in the injection site; Patient coudl not standup; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE, NAUSEA, MYALGIA, HEADACHE, and INFLUENZA LIKE ILLNESS in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 medical history was reported). Concomitant products included TRAMADOL.    On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced FATIGUE, NAUSEA, MYALGIA, HEADACHE, INFLUENZA LIKE ILLNESS, VACCINATION SITE PRURITUS and MOVEMENT DISORDER. At the time of the report, FATIGUE, NAUSEA, MYALGIA, HEADACHE, INFLUENZA LIKE ILLNESS, VACCINATION SITE PRURITUS and MOVEMENT DISORDER outcome was unknown. Not Provided          Treatment: Ibuprofen 400mg
Patient complains of soreness of left arm where shot was given and it's been almost six weeks that past. Patient taking TYLENOL and started warm compresses.
She had covid; severe vomiting; diarrhea; joint pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (severe vomiting), DIARRHOEA (diarrhea), ARTHRALGIA (joint pain), HEADACHE (headache) and SARS-COV-2 TEST POSITIVE (She had covid) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.    Co-suspect product included non-company product ATROPINE SULFATE, DIPHENOXYLATE HYDROCHLORIDE (LOMOTIL [ATROPINE SULFATE;DIPHENOXYLATE HYDROCHLORIDE]) for an unknown indication.    Concurrent medical conditions included Arthritis. Concomitant products included THYROID and PARACETAMOL (TYLENOL).   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ATROPINE SULFATE, DIPHENOXYLATE HYDROCHLORIDE (LOMOTIL [ATROPINE SULFATE;DIPHENOXYLATE HYDROCHLORIDE]) (unknown route) at an unspecified dose. On 30-Mar-2021, the patient experienced VOMITING (severe vomiting), DIARRHOEA (diarrhea), ARTHRALGIA (joint pain) and HEADACHE (headache). On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (She had covid). The patient was treated with ONDANSETRON HYDROCHLORIDE (ZOFRAN [ONDANSETRON HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 30-Mar-2021 at 12:00 PM, VOMITING (severe vomiting) had resolved with sequelae, DIARRHOEA (diarrhea) had resolved. On 31-Mar-2021, ARTHRALGIA (joint pain) and HEADACHE (headache) outcome was unknown. At the time of the report, SARS-COV-2 TEST POSITIVE (She had covid) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, COVID-19: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She took Zofran and Lomotil and Tylenol with extra strength to treat her symptoms. She is taking blood pressure medication, thyroid medication as concomitant medication.
Case number PHEH2016US023458, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 47-year-old patient of an unknown gender. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701, expiry date; not reported) at a dose of 0.5 ml intramuscular into left arm on 01 Dec 2015. It was reported that, the patient received FLUVIRIN that had been exposed to 8 to 10 temperature excursion and it was administered to unknown number of patients. No adverse event was reported following this medication error (incorrect product storage).
Severe nausea and vomiting, unable to tolerate PO intake for over 48 hrs and severe vomiting for 36 hrs
Within 12 hours, I had a temp of 100.6, aches and pains, headache, stayed in bed for 3 days.  I felt as sick at I did when I had Covid, but not congested.  Within several days, my hair started to fall out, and my cover recovery started all over again.  I had no energy and could only walk several feet at a time.
On 3/16/2021 at 7:30pm, 4.5 days after vaccine, injection site began to itch, and a red, slightly bumpy patch appeared - approximately 2.5 x 3 inches in diameter.  Patient self-treated area with "Sting Stop" gel [Active ingredients (HPUS):  Echinacea augustifolia 1X 10%, Ledum palustre 1X 10%, Urtica dioica 1X 10%.  Inactive ingredients include Citronella oil & Eucalyptus oil in a water gel base.]  Wheal itched intensely and was very slightly burning and tender for 24 hours.  There was no fever nor other symptoms.  By 7:00 am on 3/18/2021, the itching and rash were greatly diminished.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old female patient who received SHINGRIX. Concomitants products included COZAAR, LIPITOR, SYNTHROID and XANAX. On 15th May 2018 12:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm, injection site itching, injection site erythema, injection site hemorrhage, injection site macule, influenza-like symptoms and injection site rash. In May 2018, the outcome of the influenza-like symptoms was recovered/resolved. On an unknown date, the outcome of the pain in arm, injection site itching and injection site erythema were unchanged and the outcome of the injection site hemorrhage was recovered/resolved and the outcome of the injection site macule was recovering/resolving and the outcome of the injection site rash was unknown. The reporter considered the pain in arm, injection site itching and injection site erythema to be related to SHINGRIX. The reporter considered the injection site hemorrhage, injection site macule, influenza-like symptoms and injection site rash to be possibly related to SHINGRIX. Additional details were provided as follows: The patient stated that on the same evening she received the vaccine or day after, she developed pain in her arm along with redness and itching right below the site of administration. The patient had denied permission to contact their physician. All questions were asked. Limited information provided due to time constraint. On 24th May 2018, the Reporter called back to indicate that the patient developed a brown spot at the injection site which smaller than a dime about the size of a button after approximately 1-2 days after receiving the SHINGRIX vaccine. The event appeared to be resolving as it was getting lighter in color but she noticed for the first time yesterday that there were four red spots in the brown area. The patient had flu-like symptoms that resolved. She said that she still had slight rash below the injection site which was surrounding half of the left arm. The patient said that it might itch at the most twice daily and noted that there was not lot of bleeding from the injection site at the time of the initial injection.
Leg cramps, temp of 101.2, extreme exhaustion, "skin hurt", and unable to work for 2 days.
Patient has headache, nausea and vomiting since the day she got vaccination (09/02/18) until the day she saw the doctor (09/05/18) but she stated that symptoms are getting better.
5 minutes after receiving vaccine, patient stated he didn't feel so good.  Lost color in face and then fainted.  Pt layed on floor for 5 minutes.  A wet cloth was placed in forehead.  Pt came back to feeling better then sat up on floor for a few minutes then sat in chair.  Pt drank a bottle of water and called his brother for a ride.
Headache; Positive COVID test; Diarrhea; Body pain; Goose bumps; This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (Headache), DIARRHOEA (Diarrhea), PAIN (Body pain), PILOERECTION (Goose bumps) and SARS-COV-2 TEST POSITIVE (Positive COVID test) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history is provided and concomitant drugs are provided.  Concomitant products included Blood pressure medication, Cholesterol medication, Sleeping medication and Tranquilizer for an unknown indication.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), PAIN (Body pain) and PILOERECTION (Goose bumps). On 12-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive COVID test). On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache), DIARRHOEA (Diarrhea), PAIN (Body pain), PILOERECTION (Goose bumps) and SARS-COV-2 TEST POSITIVE (Positive COVID test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
**Dual report to incorporate both flu & Spikevax vaccines given. Quadrivalent Adjuvanted PF vaccine given 10/01/2023 (lot number 370679)**  11/6: He was confused. Saw his doctor on 11/7 where labs were normal. Had syncopal episode on 11/8  getting him admitted to hospital.  MRI done found multiple infarcts. TEE found thrombus vs. infection on aortic valve.   At time of report, patient is hospitalized on broad spectrum antibiotics to empirically treat infection on valve. Scheduled to have CT scan of chest & PET scan of body to help determine whether it is a thrombus or infection on valve.
Developed fever, chills, palpitations and lethargy which lasted approximately 24 hours after vaccination
Hives, slight difficulty breathing beginning approximately 1PM - hives began on right arm, then spread to left, then spread to whole body. Breathing gradually became more difficult over a period of approx. 2 hours. Benadryl was taken approx. 4PM and hives receded. The following day (9/29/2021), hives returned across the body and only receded after a double dose of Benadryl
gets some tiny cyst on arm the size of the bebe; Methicillin-resistant Staphylococcus aureus/staph infection; Cellulitis; Fatigued; High fever; Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DERMAL CYST (gets some tiny cyst on arm the size of the bebe), STAPHYLOCOCCAL INFECTION (Methicillin-resistant Staphylococcus aureus/staph infection), CELLULITIS (Cellulitis), FATIGUE (Fatigued) and PYREXIA (High fever) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa (moderate to severe).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced DERMAL CYST (gets some tiny cyst on arm the size of the bebe), STAPHYLOCOCCAL INFECTION (Methicillin-resistant Staphylococcus aureus/staph infection), CELLULITIS (Cellulitis), FATIGUE (Fatigued), PYREXIA (High fever), NAUSEA (Nausea) and CHILLS (Chills). At the time of the report, DERMAL CYST (gets some tiny cyst on arm the size of the bebe), STAPHYLOCOCCAL INFECTION (Methicillin-resistant Staphylococcus aureus/staph infection) and CELLULITIS (Cellulitis) was resolving and FATIGUE (Fatigued), PYREXIA (High fever), NAUSEA (Nausea) and CHILLS (Chills) had resolved.            Concomitant medication of the patient was not reported.  Formulation of Humira (Adalimumab) was reported as solution for injection in pre-filled pen. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was provided by the reporter.  Causality for Humira(Adalimumab): The reporter's causality for the event(s) of gets some tiny cyst on arm the size of the bebe, fatigued, high fever, nausea, chills, cellulitis and methicillin-resistant staphylococcus aureus/staph infection was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2022: Upon live follow-up additional new events, suspect vaccine dosing details and event related information (duration of some events) were added.
Rt thigh cellulitis 7cm x 8cm covering both injection sites. Had been to ER/on Keflex when seen in office; hospitalized x 1 day. DTaP thought to be cause. Medical records state fever, rash. msv
Pfizer vaccine was administered outside of clinic- reported by patient- ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------------------- PERIPHERAL NEUROPATHY 5/26/2021 UNSPECIFIED ANXIETY  ACUTE DVT, UNSPECIFIED VEIN 6/16/2021 UNSPECIFIED ANXIETY  PERIPHERAL NEUROPATHY 5/26/2021 NAUSEA AND VOMITING  ACUTE DVT, UNSPECIFIED VEIN 6/16/2021 NAUSEA AND VOMITING  PERIPHERAL NEUROPATHY 5/26/2021 BODY ACHES  ACUTE DVT, UNSPECIFIED VEIN 6/16/2021 BODY ACHES
General hive through out body approximately few hours (1-4 hrs) after administration of vaccines, patient went to ER & received BEBADRYL per mom.
Shingles outbreak. Muscle pain, then rash on right side of the torse, blisters.  Contacted Doctor on 03/09/2021 via online portal, described symptoms and sent images of the rash. Doctor prescribed Valacyclovir. The illness is still going on (03/12)
Severe flu like symptoms-headache, fever, chills, body aches starting around 7:00 pm same day. Persisted through Sunday. Starting Saturday afternoon, severe lower abdominal pain. Persisted through Sunday. To lesser degree felt symptoms in waves until Wednesday.
Patient began feeling sweaty, shaky, and nauseated. Eventually started ?seeing stars.? BP 40 min after vaccine was 90/50 pulse 110. Patient advised to drink water. 1 he 10 min after BP 140/80 pulse 80 stated she was feeling a little better but wanted to go home with roommate. Advised if symptoms are still present would prefer she stay on site but she declined. Counseled on signs and symptoms which would warrant further follow up. At no point did the patient complain of difficulty breathing, sore throat, mouth or facial swelling, or itching.
fever 5 hrs /p DTP, Pt stiffened- head back, eyes closed, bacame limp, did not respond to attempts to awaken. Slept 12 hrs.
4 year old female received Quadracel in left thigh,No AE; 4 year old female received two doses of Quadracel within 6 months,No AE; Initial information received on 30-Jun-2020 regarding an unsolicited valid non-serious case received from other healthcare professional (Medical assistant).  This case involves a four years old female patient who received two doses of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] one in Dec-2019 and other 0.5 ml on 29-Jun-2020 with lot number: C5688AA, expiry date 26-NOV-2021 via intramuscular route in the left thigh) within 6 months for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for prophylactic vaccination on  29-Jun-2020.  It was an actual medication error case due to extra dose administered and vaccine administered at inappropriate site.  No adverse event symptoms occurred to the patient.  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.
Information has been received from a nurse concerning three children, ages 7, 11 and 13 years old (age of patient not specified) of who on 23-JUN-2006 were vaccinated with Vaqta. Regarding this patient, the patient was administered the vaccine subcutaneously. The second dose of the region was administered on 28-Jul-2006, approximately 1 month after first dose. The patient also experienced redness of upper extremity. Unspecified medical attention was sought. No product quality complaint. Additional information has been requested.
Narrative:  product was administered after beyond use date. Manufacturer then CDC were contacted and because we could not guarantee potency of product, the recommendation was to revaccinate ASAP.
This spontaneous report was received from a medical assistant regarding a 68 years old female patient with asthma, osteopenia, hypertension, hypercholesterolemia, hypothyroidism, rheumatoid arthritis, melanoma, allergy to sulfa drugs, allergy to NORVASC, allergy to nystatin, allergy to LIPITOR and allergy to lisinopril. The patient's medical history included tachycardia, abnormal thyroid tests, carotid artery stenosis and abnormal liver function tests. On 24-JUL-2009, the patient was vaccinated subcutaneously with dose 1, 0.65 milliliter (ml) ZOSTAVAX. On 01-NOV-2012, the patient was vaccinated subcutaneously with dose 2, 0.65 ml ZOSTAVAX (lot# reported as 013017, expiry 09-OCT-2013). Concomitant medications included SYNTHROID, nitroglycerin (manufacturer unknown), PLAQUENIL, fluticasone propionate, ADVAIR DISKUS, CRESTOR, PROAIR HFA, omeprazole (manufacturer unknown), felodipine (manufacturer unknown) and atenolol (manufacturer unknown). On 01-NOV-2012, after administration of second dose the patient experienced body aches, chills, diarrhea, fatigue and headache. The patient sought medical attention (called Healthcare professional (HCP)). No treatment was given for the events. On 05-NOV-2012, the patient called her physician and reported that the adverse reactions had abated. The relatedness for body aches, chills, diarrhea, fatigue and headache was unknown for ZOSTAVAX. Additional information has been requested.
Diarrhoea; Fever; Patient has been feeling poorly; Sick; Headaches; Stomach pains; Body aches; This is a spontaneous case, reported by other non-health professional (consumer) to Med Communications (reference number: SEQ20-00530) on 05-Feb-2020, concerning a 43-year-old female patient.   The patient's medical history and concomitant medications were not provided.  On 09-Dec-2019, the patient was administered unspecified flu vaccine seasonal [influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number and expiry date: not reported) for prevention of seasonal influenza.  On the same day, after vaccination, the patient started to be sick. She was feeling poorly and developed stomach pain, diarrhoea, fever and headache.  On an unspecified day in Dec-2019, approximately a week and a half after vaccination, the patient started to have body aches.  Tamiflu (oseltamivir phosphate) was prescribed by patient's physician as a treatment for the events.  At the time of this report, the outcome of all events was not resolved. It was reported that the patient was still experiencing the symptoms of the events.  The case was assessed as non-serious.  The reporter did not provide causality assessment to unspecified flu vaccine seasonal.  Company comment: The patient experienced abdominal pain upper, pyrexia, diarrhoea, feeling abnormal, malaise and headache on the same day after receiving unspecified flu vaccine seasonal. The patient also developed pain (body aches) a week later. Chronology is plausible. More information regarding medical history is needed. With information available, causal role of the suspect vaccine is assessed as possibly related for all events.; Sender's Comments: The patient experienced abdominal pain upper, pyrexia, diarrhoea, feeling abnormal, malaise and headache on the same day after receiving unspecified flu vaccine seasonal. The patient also developed pain (body aches) a week later. Chronology is plausible. More information regarding medical history is needed. With information available, causal role of the suspect vaccine is assessed as possibly related for all events.
Patient states he received his booster Materna Covid shot approximately 3 weeks ago and he feels that since this immunization was given, he has lost ground in terms of ability to walk distance and overall energy level.  He has not had any overt shortness of breath and denies any chest pain or ankle swelling.   Comes in the clinic this morning with an EKG obtained this morning showing atrial flutter with a variable ventricular response same as previous.
6/30/08 11AM Child here for physical exam.  Nurse adm. vaccines - child fainted.  Recovered quickly.  No intervention necessary.  B/P 102/66.