chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a consumer's husband refers to a 62 years old female patient. It was reported that the patient had a healthy immune system and had no history of cold sores. On an unknown date, the patient was vaccinated with ZOSTAVAX, single dose injection. Other suspect therapies included AFLURIA and pertussis vaccine (unspecified) were administered within the same week as with ZOSTAVAX. No concomitants were reported. On 28-JAN-2014 (also reported as a few weeks later), the patient developed body aches and a low-grade fever. The body aches were accompanied by a constant dull headache. On an unknown date in 2014, the fever worsened and the patient developed symptoms of a Urinary tract infection (no UTI was confirmed) and severe discomfort in her throat, which included difficulty in swallowing. Patient visited to a walk-in clinic (unspecified), where she was prescribed LEVAQUIN. The patient then visited her physician. where she was examined. On an unknown date in 2014, the patient developed white tongue and canker sores in her mouth and she began to experience more severe problems in swallowing and was unable to eat or drink. The patient sought the attention of an Infectious Disease Specialist and on 04-FEB-2014; she went to the Emergency Room and was hospitalized on 04-FEB-2014. On an unknown date in 2014, lab diagnostics studies included blood, urine tests, endoscopy, cultures, biopsies were performed. She was diagnosed with unspecified herpes virus blisters in her throat. Patient received acyclovir by intravenous administration in hospital and CARAFATE to coat the ulcerations. BACTRIM and vancomycin were also given as treatment. She was discharged on 09-FEB-2014, and was reportedly able to eat and drink lightly, but was still uncomfortable. All the reported events were recovering/resolving. Causality assessment was not provided. Additional information has been requested.
Urticarial rash at neck, face and lips several minutes after receiving annual flu vaccine. Sent to ED for observation - resolved fully after IM BENADRYL 50 mg, ALLEGRA 60 mg PO, Ranitidine 150 mg PO.
Patient states that she began feeling pain at the injection site several days following the vaccine administration. The pain initially presented at the site of vaccination, then began moving up the arm toward the shoulder and into the rotator cuff area. The pain progressively worsened to the point of the patient being unable to move her arm easily or get comfortable. She states that she was experiencing constant pain at rest and increased pain upon movement of the arm. She was seen by her PCP on 11/10/2020 for evaluation. She was prescribed meloxicam, methocarbamol, and lidocaine patches.
DIFFICULTY IN DRAWING BLOOD FROM FINGER; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced difficulty in drawing blood from finger. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of difficulty in drawing blood from finger was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
4/24 3:08 Pm - Dad called the office to report the baby had been crying for 1 1/2 - 2 hrs Inj site (LF th) red. recommendation to give Tylenol every 4 hrs - today and following day, cool compresses to thigh. We would call later with follow up. No known fever. 4/24  - 710 Pm pt no longer crying T 100.8. 4/24 - 10 Pm  - fever 102.2, whiney, fussy - spoke with physician on call
Patient was unresponsive with eyes open for a brief moment  ( 5 seconds) after receiving the vaccine.
Fever Chills Cellulitis (seen by OBGYN) Fatigue Headache
8/19 - Client had rash evening/night, temp 103.  Next day, 8/20, temp 101.  Left arm became extremely swollen, Mom described 2-3 x normal size, red and hot.  Advised Dr. to evaluate.  Mom took client to PCP.  Says prescribed antibiotic and Tylenol #3.  Mom says on 8/21 arm better and almost normal size.
High levels of burning when urinating as well as most of the time.  Sense of urgency in needing to pee.  Discomfort- feeling like shards of glass between my legs. Sleep at night limited to 1.5 hours before needing to pee.   Started 4/17/2021 and continuing up to today (7/13/21)
could not sleep last; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of insomnia in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 01-NOV-2023, the patient received Arexvy. In NOV-2023, an unknown time after receiving Arexvy, the patient experienced insomnia (Verbatim: could not sleep last). The outcome of the insomnia was not reported.   It was unknown if the reporter considered the insomnia to be related to Arexvy.     It was unknown if the company considered the insomnia to be related to Arexvy.   Additional Information: GSK Receipt date: 02-NOV-2023 This case was reported by patient via (Open field AE monitoring) interactive digital media. A patient reported that he/she had shot one day before reporting (yesterday) and could not slept last. Follow up was not possible, as no contact details were available.
Developed extreme case of eczema covering entire body.  Itching, scaling, not resolved.  Never had eczema before this time.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Lot number: C-H9694) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "tinnitus in ears" (unspecified if ongoing), notes: Other medical history: tinnitus in ears; "arthritis in knees" (unspecified if ongoing), notes: Other medical history: arthritis in knees; "high homocysteine" (unspecified if ongoing), notes: Other medical history: high homocysteine. Concomitant medication(s) included: LOVASTATIN, start date: 07Nov2021, stop date: 12Mar2023; CENTRUM A TO ZINC taken for vitamin supplementation, start date: 01May2022, stop date: 22Mar2023; BABY ASPIRIN, start date: 03Jul2022, stop date: 22Mar2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient had no known allergies.  No follow-up attempts are Possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162b2, BNT162b2 omi ba.4-5  vaccine can not be excluded for the reported events of COVID-19 and drug ineffective due to temporal relationship.  Case will be re-assessed upon the additional information provided.
Arm red with swollen from elbow up to shoulder: 2 days. Very sensitive to touch: constant pain and weakness: 2 days.
Nasal congestion; Rashes; Covid rash; Itchy arm; Back pain; Within an hour shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Within an hour shortness of breath), BACK PAIN (Back pain), NASAL CONGESTION (Nasal congestion), RASH (Rashes) and VACCINATION SITE RASH (Covid rash) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced DYSPNOEA (Within an hour shortness of breath). On 20-Mar-2021, the patient experienced BACK PAIN (Back pain). On 25-Mar-2021, the patient experienced RASH (Rashes), VACCINATION SITE RASH (Covid rash) and VACCINATION SITE PRURITUS (Itchy arm). On an unknown date, the patient experienced NASAL CONGESTION (Nasal congestion). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency. On 18-Mar-2021, DYSPNOEA (Within an hour shortness of breath) had resolved. On 27-Mar-2021, RASH (Rashes), VACCINATION SITE RASH (Covid rash) and VACCINATION SITE PRURITUS (Itchy arm) had resolved. On 03-Apr-2021, BACK PAIN (Back pain) had resolved. At the time of the report, NASAL CONGESTION (Nasal congestion) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
I took the vaccine around 8:15 am at Hospital. They had a special event for Employees. After I was home I felt extremely tired and that improved after i laid down for a bit. However, around 7 PM I became very cold and had a temperature of 100.3 with chills/shakes. It has lasted into the next day with chills being on and off. I experienced muscle cramps as well has some chest discomfort.
Extremely dizzy..felt light headed..had to lie down..continued dizziness..received 2nd dose Hep B 8/11/2010..not realizing the vaccine was causing the dizziness...finally realized around end of Nov. beginning of Dec. was no longer dizzy...declined third dose
About 1 hours, post vax, both arms and legs were stiff. Felt like they were falling asleep. Nauseated, which lasted 5-6 hours. Went to bed and went to sleep. Was OK the next AM.
This spontaneous report was received from a nurse and refers to a 15 year old patient of unknown gender. No information was provided regarding the patient's medical history, concomitant medications or drug reactions/ allergies. On an unknown date, patient received the first dose of GARDASIL 9 of the HPV vaccination series for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unspecified date, 3 months after the first dose of GARDASIL 9 was administered, the patient received the second dose GARDASIL 9 in the HPV vaccination series (Inappropriate schedule of vaccine administered). On unspecified date, 6 months after receiving first dose of GARDASIL 9, the patient received the third dose of GARDASIL 9 in the HPV vaccination series. The outcome of inappropriate schedule of vaccine administered was not reported.
. By The evening my armwas incredibly sore. I could not lift aglass of water with the arm thatreceived the shot; Pounding headache for about 20 hour; Small fever for about 24 hours; Very tired; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm on 10Apr2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient had no known allergies. Concomitant medications were not reported. Prior to the vaccination, 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 10Apr2021 at 18:00, the patient experienced arm was incredibly sore, could not lift a glass of water with the arm that received the shot, pounding headache for about 20 hours, a small fever for about 24 hours, tired. Patient also stated that she had no/little side effects after the first dose. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events arm was incredibly sore, tired recovered on an unspecified date in Apr2021. Whereas, pounding headache, small fever recovered on 11Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
We were traveling and I started to develop a throat irritation and cough and felt like something I get every 3 years. It developed over the next 7-10 days. When we returned home I went to the doctor's on the 29th. I was taking rapid test at least every day and they were negative. I was told I have a sinus infection. I was prescribed AUGMENTIN for 10 days and was starting to feel better towards the end of the dosage. Then my husband tested positive for COVID-19 on the 9/6. On 9/8 I started feeling bad again, took a rapid test and it was negative. I went to get a PCR test and it was positive on 9/8. I was prescribed PAXLOVID for 5 days. At the end of the dosage I felt better and I tested negative. My husband then felt better and was negative then rebounded. Three later I rebounded and started feeling bad and tested positive with COVID-19. 1 day of sore throat, bad cough, runny nose. By the 20th I tested positive on the rapid test for the first time. On the 23rd I tested negative and have been feeling better since then.
Shortness of breath and Feelings of having a fast-beating, fluttering, or pounding heart. Last for a few days shortly after the second injection. Didn't realize that these are the symptoms of Myocarditis
patient was waiting her 15 minutes.  After 12 minutes she reported to the pharmacy consultation window to report the feeling of itching all over from her chest up.  The pharmacist observed red hives on her forehead and neck. She verified with the pharmacist that she had no issue with her tongue, throat, or breathing.  pharmacist administer 25 mg of benedryl  and observed patient for another 30 minutes after calling her primary doctor.  Patients blood pressure was within normal limits before being driven home by her husband
Administered flu mist at public clinic 10-11-08, in a large room. Worked from 10 am to 4:43 pm. IM and FluMist given. During clinic lungs became tight and I required Ventolin inhaler. Sunday night became ill, asthma. Saw MD on Monday and Wed. Started on predinisone 60 mg, tappering q 3 days. Increased Advir, I have 7 doses, nurses in close proximity to me gave a toatl of 39 doses of FluMist. MedImmune Lot 500646P. IM Flu vaccine given during clinic.
This case was reported by a medical assistant and described the occurrence of hives in an 11 year old male patient who receive hepatitis B vaccine recombinant (Engerix-B).  On an unspecified date in 2000, the patient received a dose of Engerix-B.  At an unspecified time following administration of Engerix-B, the patient developed hives.  The patient was examined at a physician's office and was treated with oral corticosteroids.  The event resolved.  Report received via Merck and Co.
Moderate blockage or arteries. The first thing they did as put a stint in the right side to get a blood flow. 8 weeks later, they did the enterectomy of the left corroded artery. Currently, I've recovered from the artery issues. They did a follow up check of the flow rate. The enterectomy was almost totally at normal. Had to take plad ax to modify the chemistry of the blood.
itching; with round red rash at the injection site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (with round red rash at the injection site) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (with round red rash at the injection site). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at an unspecified dose and frequency and TRIAMCINOLONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (with round red rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the event included cetirizine (Zyrtec) and triamcinolone cream.  No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the other events, a causal relationship cannot be excluded.  The reported events are consistent with the product known safety profile.
Patient presented to emergency department on 7/722 with increased fatigue and generally not feeling well. Patient tested positive for COVID just after midnight on 7/18/22. She was intubated in the emergency department.
She presented to the ED on 4/30/21 due to left sided chest pain. She was found to have acute pericarditis with no identifiable source. Unclear if vaccine is related but did receive vaccine on 4/21/21 before this developed. currently being managed by cardiology with.
Delayed hypersensitivity reaction with morbilliform rash, along with slight itching, starting 28 hours after the injection.
Information has been received from a certified medical assistant (CMA) concerning a 25 year old female who on 06-DEC-2006 was vaccinated with first dose of Gardasil (lot # 653736/0868F). On 06-FEB-2007, the patient was vaccinated with second dose of Gardasil (lot # 655165/1425F) IM in the right arm. There was no concomitant medication. On approximately 02-MAR-2007, about one month after the vaccination, the patient experienced tingling and pain at the injection site (unspecified duration), and a lump of undetermined size at the injection site. The patient sought medical attention. at the time of reporting, the tingling and pain at the injection site and lump of undetermined size at the injection site persisted. No other information was available at the time of reporting. Additional information has been requested.
Narrative:  Patient received Moderna COVID vaccine #1 on 3/13/21. No other notes entered and date of death was recorded as 4/2/21. No scanned records or autopsy reports available. Time from administration of vaccine to date of death is 20 days.
pt recv vax 3APR97 & 15APR97 pt devel a rash consisting of hive-like lesions @ inj site as well as less than 30 varicella-like lesion on trunk;
Approx 12 hours after vaccination had severe headache , few hours later, nausea, then vomiting  X 3 and some loose bowel movements. Possible fever but did not take temperature. Symptoms subsided about 30 hours after vaccination.
1/2 hr p/vax pt began sx sweats, tachycardia, nausea, restlessness & feelings of anxiety or uneasyness; could not sleep & reported to ER in AM 22AUG93; given DPH sx subsided x/h/a;
Developed hives on her arms and legs; This spontaneous case was reported by a nurse and describes the occurrence of URTICARIA (Developed hives on her arms and legs) 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 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 11-Jan-2021, the patient experienced URTICARIA (Developed hives on her arms and legs). At the time of the report, URTICARIA (Developed hives on her arms and legs) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   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.; 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.
Increased Heart Rate 5 minutes after injection. 100-115 lasting for 5-10 minutes while at rest. Increased HR repeated several times the next 12hrs while at rest, at home.  Fatigue, headache (for 48hrs) and injection site swelling (entire deltoid was a solid lump).  Swollen lymph nodes in arm pit of injection arm.
Mother reports after shots given broke out in rash & hard induration on Rt. thigh. Continues 10/8.
Pain, redness day of shot, migraines for 5 days, rawness on roof of mouth at the back near throat (but not in throat), today: pain, swelling, itching and lump under skin at injection site
I95.9 HYPOTENSION 1/3/2023 SHORTNESS OF BREATH J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/3/2022 SHORTNESS OF BREATH J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 1/3/2023 SHORTNESS OF BREATH R57.1 HYPOVOLEMIC SHOCK 12/3/2022 SHORTNESS OF BREATH R57.9 SHOCK, UNSPECIFIED 1/3/2023 SHORTNESS OF BREATH I95.9 HYPOTENSION 1/3/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE    NONTRAUMATIC ACUTE KIDNEY INJURY J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/3/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE    NONTRAUMATIC ACUTE KIDNEY INJURY J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 1/3/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE    NONTRAUMATIC ACUTE KIDNEY INJURY R57.1 HYPOVOLEMIC SHOCK 12/3/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE    NONTRAUMATIC ACUTE KIDNEY INJURY R57.9 SHOCK, UNSPECIFIED 1/3/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE    NONTRAUMATIC ACUTE KIDNEY INJURY
R09.02 HYPOXIA 6/13/2021 ADENOCARCINOMA, OVERLAPPING SITES OF LEFT LUNG
muscle pain, muscle weakness and cramps; joint pain; chills and being too cold to sleep and too weak to get up and find a warmer blanket; dizziness and physical instability; inability to sleep; pain and itching at injection site. The most severe symptoms ran from about 7 p.m. Nov 29 to about 4 a.m. Nov 30. After that most symptoms eased, leaving me exhausted.
Employee had tongue tingling after injection denies swelling, SOB, chest pain. She waited 30 minutes and declined ED evaluation there were no further symptoms after observation.
Child did not experience an adverse effect , she was accidently given the flu shot. Nurse realized the mistake after administration and the DR was quickly made aware. DR spoke to the parent and the baby was fine before leaving the clinic .
Per pt, experienced weakness, fatigue, rash at injection sight, SOB, lightheaded, elevated HR and BP. Pt received vaccine doses at Hospital.
3 days following vaccination patient developed fever to 102, irritability, rash, wheezing
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a six-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 07-Dec-2011, the patient received expired FLUMIST. The product expired on 20-Nov-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.