chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrhea/ His diarrhea was worse than the older sons; first dose in his right thigh.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 5 year-old male patient received bnt162b2 (BNT162B2), administered in thigh right, administration date 14Dec2021 (Lot number: FL0007) at the age of 5 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU, administration date 2021. The following information was reported: DIARRHOEA (non-serious) with onset 15Dec2021, outcome "not recovered", described as "Diarrhea/ His diarrhea was worse than the older sons"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 14Dec2021, outcome "unknown", described as "first dose in his right thigh."  Additional Context: Caller was the mother and was called to report that her two sons had diarrhea after getting the COVID vaccine shot yesterday afternoon, 14Dec2021. Both of her sons are going to the bathroom like clock work. Both sons got the vaccine at the hospital. They started having diarrhea this morning. The diarrhea started this morning. The diarrhea started slow, but has continued. His diarrhea was worse than the older sons. This was withheld first dose in his right thigh. She doesn't know his exact height, but she does know he was over 4ft. He did get a flu shot a week or two ago.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101797686 Same reporter/drug/event, different patient.
This spontaneous report as received from a nurse, refers to patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, two patients were vaccinated with improperly stored (Oka/Merck) VARIVAX injection (lot # L011806, expiration date: 21-AUG-2016) (strength, dose and route unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaint (PQC) involved. No further details were provided. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
At approx 1am following my vaccination I experienced extreme chills/shivers, confusion, slurred speech, nausea, headache, dizziness, inability to stand and a fever of 103.2F   The symptoms continued after sunrise, however, they were less severe.   Today (4/12/21) I am still experiencing headaches and feel extreme exhaustion and fatigue. I have not been able to work a full day since the day of vaccination
Pt vaccinated with Pneumovax 23 developed a sterile abscess at the injection site & a temp 102. Arm was aching & swollen. Treated w/Cefadroxil.
swollen eye; hives; This is a spontaneous report from a contactable Nurse, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EH9899), via an unspecified route of administration on 11Jan2021 at 15:30 (at the age of 35-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included insulin resistance, vitamin D deficiency, GERD (Gastrooesophageal reflux disease) and allergy to pollen and possible allergy to cilantro. Prior to the vaccination, it was unknown if the patient was not diagnosed with COVID-19.  Concomitant medications included metformin, famotidine (PEPCID [FAMOTIDINE]), clarithromycin (CLARITIN [CLARITHROMYCIN]), topirmate, and diphenhydramine hydrochloride (BENADRYL); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took pregabalin (LYRICA) from an unknown date for an unknown indication and experienced allergy. On 01Feb2021 at 06:00, the patient experienced hives and swollen eye. The patient reported that the first vaccine was administered and the patient was fine then the patient had hives and swollen eye on the day the second dose was to be administered. The second dose of the vaccine was delayed. The events resulted in an emergency room/urgent care visit and the patient received treatment for the events with solumedrol shot and prednisone oral with benadryl/pepcid/atarax.  The patient received the second dose one week later, on Friday 05Feb2021, with prednisone on board. The clinical outcomes of the hives and swollen eye were recovering. It was also reported that since the vaccination, it was unknown if the patient had been tested for COVID-19.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Swollen eyes and Hives cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Patient reports tingling sensation in throat within 5 minutes of injection. She looked at tongue in mirror and noted tongue swelling. She reports observer at vaccine area also saw swelling. Swelling not thought sufficient for treatment or emergency care. Symptoms all resolved by 20 minutes.
Information has been received from a physician concerning a 20 year old female who was a previous smoker and took birth control pills in the past, who on 21-FEB-2007 was IM vaccinated with her first dose of GARDASIL (lot number unspecified).  On 25-Apr-2007 she was IM vaccinated with her second dose of GARDASIL (lot number unspecified).  On 25-Aug-2007 the patient received her third dose of GARDASIL (lot number unspecified) intramuscularly.  Concomitant therapy included hormonal contraceptives (unspecified) in the past.  A pap test on 07-Feb-2007 was negative.  A repeat PAP test on 07-Aug-2007 was positive for low grade dysplasia CIN 1.  She was also HPV positive for one of the high risk groups.  Colposcopy on 06-Sep-2007 confirmed CIN 1.  The patient had Cryotherapy on 27-Sep-2007.  A pap in February 2008 still shows low grade dysplasia.  The patient sought medical treatment with an office visit.  The patient has not recovered.  Additional information has been requested.
Sore arm at injection site; light rash all over body that continued (so far) for two days.
Violent rash red and inflamed that kept spreading with the days. It started on the wrists, then groin area, then under arm towards left arm, then towards trunk, then from left ground to left leg, then to arms, legs, face, neck... Doctors confirmed Gianotti-Crosti syndrome
Information has been received from a physician concerning a female teenager who on an unspecified date was vaccinated with the first dose of GARDASIL (lot number, site and route not reported). the patient developed a very large swollen area around injection site after receiving GARDASIL. Subsequently, the patient recovered from the event. Unspecified medical attention was sought. Additional information has been requested.
Symptoms started on 4/25/2022 with Fatigue and some wooziness, then Nausea (belching) along with fatigue and wooziness the next day 04/26/2022, then on 04/27/2022 I had a severe headache.  More fatigue on 4/28/2022 thru 05/01/22 then nausea and diarrhea on 05/02/2022.
VARIVAX was accidently given instead of ZOSTAVAX to 61 year old patient. Manufacturer said to revaccinate with ZOSTAVAX in 28 days.
tested positive for Covid; tested positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL0142), in arm, on 09Feb2021 as dose 2, single (Lot number: EL3247), in arm and on 30Oct2021 as dose 3 (booster), single (Lot number: 0809) at the age of 76 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Anal Cancer", start date: 2013, stop date: Aug2013, notes: Pertinent Details: Chemo/Radiation Remission; "Heart Disease", start date: 16Feb2016 (ongoing), notes: Pertinent Details: 3 stents placed; "Hypothyroid" (unspecified if ongoing); "Lipid high" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID] taken for cardiac disorder, start date: 2016 (ongoing); CO Q10, start date: 2001; PRAVASTATIN taken for hyperlipidaemia, start date: 2001 (ongoing); PLAVIX taken for cardiac disorder, start date: 16Feb2016, stop date: 29Apr2022; SYNTHROID taken for hypothyroidism (ongoing); VITAMIN C ACID, start date: 2000; VITAMIN D NOS, start date: 2019. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (11Jan2021) not detected; (28Jan2021) unknown results, notes: Test Method: Nucleic Acid Amplification Test including  reverse transcription polymerase chain reaction (RT-PCR)  and transcription mediated amplification (TMA); (17Apr2022) not detected, notes: Specimen information: Nasopharynx, swab. Therapeutic measures were taken as a result of vaccination failure, covid-19 included 14Oct2022 treated with paxlovid, Will treat again week ending 28Oct2022.
Her thyroid got bigger; This is a spontaneous report received from a contactable reporter(s) (Nurse), Program ID: The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GOITRE (non-serious), outcome "unknown", described as "Her thyroid got bigger". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Narrative: RECEIVED VACCINATION ON UNKNOWN DATE AT UNKNOWN LOCATION, HISTORICAL REPORT TO PRIMARY CARE MD
Initial report received from a health care professional on 15 February 2011. A 21-year-old male patient on 10 February 2011 at 4:30 PM received a right arm subcutaneous injection (dose 1) of MENACTRA, lot number U3473AA, a left arm intramuscular injection of HAVRIX, GSK lot number AHAVB443AB, and a right arm influenza vaccine lot number 111796P1. The patient had no medical history and had an allergy to sulfa drugs. The patient took no concomitant medications, had no illness at the time of vaccination and no other vaccinations within 4 weeks. On 12 February 2011 at 12:00 PM he experienced symptoms of a 4 inch area of redness, warmth and soreness at the injection site with body aches and headache. He required a doctor visit and the patient was treated with BENADRYL. The outcome was reported as unknown. Documents held by sender: None.
Severe headache, nausea, muscle aches, chills. Severe objection due soreness. Mild fever. Had to miss work the day after administration.
Flu like symptoms; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a  patient of an unknown age and gender 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.            No concomitant medication were provided by reporter. No treatment was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
Moderna COVID?19 Vaccine EUA Nausea, body aches, sore arm, mild dizziness
Pneumonia shot given 12/17/04. That evening severe pain. Unable to move ex. leg L in any direction. Sat morning deathly white and faced blackening int. Her sister rush her to the ER. Pain in the ex. leg lasted for several days. 2AM able to move the ex. leg with discomfort.
Patient was given an adult dose of Havrix Hepatitis A vaccine at 16 years old, should have received a pediatric dose. No adverse reactions or symptoms have been reported to Health department.
Information has been received from a physician concerning a 16 year old female relative with no pertinent medical history or drug reactions/allergies, who on 06-APR-2007 was vaccinated with a first dose of Gardasil, 0.5 ml, intramuscularly. Concomitant therapy included (YAZ). On 09-APR-2007 the patient experienced sweats, chills and diarrhea. Since this initial episode the patient experienced three to four similar incidences. All of the incidences have occurred one hour after eating meat. No laboratory tests were performed. The patient's sweats and chills and diarrhea after eating meat have persisted. Additional information has been requested.
Bloody sclera (started 6 hours after injection, both eyes), sore throat.
Side effects: Chills, fever, headache, weakness, slight nausea Symptoms ended 24 hours later
Kidney stones; Shingles on face; Very painful; This case was reported by a consumer via interactive digital media and described the occurrence of renal stone in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (the patient's wife had shingles).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced renal stone (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the renal stone, shingles and pain were unknown.   It was unknown if the reporter considered the renal stone, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 08-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that his wife had shingles and she was insisted him to receive Shingles vaccine. The patient received Shingles vaccine and four days after receiving Shingles vaccine he experienced Shingles on his face and it was very painful but not as painful as his kidney stone. Additional supportive information: Follow-up would not possible as no contact details were available. As the start date for kidney stone was not available conservatively the kidney stone was captured as event.
was not able to take the second dose of the Moderna vaccine as scheduled; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (was not able to take the second dose of the Moderna vaccine as scheduled) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (was not able to take the second dose of the Moderna vaccine as scheduled). At the time of the report, PRODUCT DOSE OMISSION ISSUE (was not able to take the second dose of the Moderna vaccine as scheduled) outcome was unknown.        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.   No concomitant medications reported. No treatment reported.
Head ache, chills, body aches - subsided on 5/28/2021.
12:10 PM - Patient honked horn and RN responded. Pt lightheaded, short of breath. "Chest felt heavy." 12:16 PM - 911 called, vitals (BP 140/76, Pule 50, RR 20, Ox 93%) 12:19 - EMS on scene. Pt still short of breath but talking, vitals remained stable. Pt c/o headache. Pulse ox 94-95% 12:30 - Pt transferred to hospital for cautionary monitoring
Pediatric dose admiistered to adult; Adult use of a child product; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 20-year-old female patient who received HAV (Havrix 720) (batch number D7HA9, expiry date 27-AUG-2024) for prophylaxis.   On 23-MAR-2023, the patient received Havrix 720. On 23-MAR-2023, an unknown time after receiving Havrix 720, the patient experienced underdose (Verbatim: Pediatric dose admiistered to adult) and adult use of a child product (Verbatim: Adult use of a child product). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-MAR-2023 The health care professional reported the case for a patient. The patient received Havrix 720 (pediatric) dose. The reporter consented to follow up. The patient received pediatric dose of Havrix 720, which led to underdose and adult use of a child product.
Called for telehealth visit after receiving 4th dose, prescribed Paxlovid symptoms subsided after a day or two.
Delayed, large local reaction - red, raised, 6 x 8 cm - indurated warm.
Had a sore arm for about 36 hours, no problems. Then one week later the arm got itchy and a mild raised red rash has developed. Continues to itch and have increasing rash on day 8.
Patient states she has been having mild pain that comes and goes.  It started after her immunization.  During consultation, she motioned toward her right arm, though she received the immunization in the left arm.
LEFT HAND TURNING BLUE; CHILLS/ SHIVERING; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 18-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced fever. On 18-MAR-2021, the subject experienced chills. On 18-MAR-2021, the subject experienced shivering. On 18-MAR-2021, the subject experienced left hand turning blue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, shivering, and left hand turning blue. This report was non-serious.
pt recv vax 21NOV95 & on 19JUN96 pt exp breakthrough varicella;
both arms contracted against chest-fingers not aligned;no control over movement;unable to ambulate or perform personal hygiene tasks;paresthesia all extremities;muscle pain;h/a,myalgia,cephalgia,blurred vision;Heglund's deformities;
Fever, muscle aches and fatigue onset approx 6 hours after vaccine. Nausea onset approx. 36 hours after vaccine, resulting in persistent vomiting. Nurse line recommended going to urgent care, was given fluids, and anti-nausea meds. Prescribed zofran.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Regulatory authority consulted with the regulatory authority and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare facility working with the regulatory authority on a compliance improvement plan and has been reinstated vaccination privileges.
I felt incredibly tired, fatigued the evening after I got the shot in the morning.  I also had body aches all over.  These symptoms lasted approximately 60 hours.
COVID 19 Treatment; COVID 19 Treatment; vaccine brand=Pfizer / BioNTech; vaccine administration date=13Apr2023; vaccine brand other=MODERNA, vaccine administration date=04Mar2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 91-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Apr2023 at 12:30 as dose 3 (booster), single (Lot number: GL0447) at the age of 91 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Feb2021 at 11:15 as dose 1, single (Lot number: 013M20A), in left arm and on 04Mar2021 at 13:15 as dose 2, single (Lot number: 012A21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "atrial fibrillation" (unspecified if ongoing); "enlarged prostate" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "seasonal allergy" (unspecified if ongoing); "mild asthma" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE, start date: May1993, stop date: 07May2023; TERAZOSIN, start date: Jul1956, stop date: 07May2023; FINASTERIDE, start date: Jan1980, stop date: 07May2023; METOPROLOL, start date: Feb2021, stop date: 07May2023; APIXABAN, start date: Mar2017, stop date: 30Apr2023; FLUTICASONE, start date: May1984, stop date: 07May2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 13Apr2023 at 12:30, outcome "unknown", described as "vaccine brand=Pfizer / BioNTech; vaccine administration date=13Apr2023; vaccine brand other=MODERNA, vaccine administration date=04Mar2021"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures paxlovid from 30Apr2023 to 05May2023 was taken as a result of drug ineffective, covid-19.
Patient received first dose at another pharmacy. One week later he got covid and states that he was told by hospital representative that he  needed to start the vaccine series over and repeat his first shot before getting a second. He received the 2nd and 3rd at another pharmacy. We were unaware that he had received the previous vaccination.
BAD COUGH; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient never had a fever. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced bad cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad cough was not reported. This report was non-serious. This case, from the same reporter is linked to 20211018110 and 20211018825.
Pt's an 18 year old, status post meningitis shot, 2 days ago, had pain L arm. Also had generalized body aches. Arm site got swollen. Had fever yesterday of 101F with chills. No pain before shot. Today has pain underneath arm to shoulder joint. On exam, eyes slightly swollen. Dx'd with reaction to Menactra. Tx: Motrin Q6 hours and follow up is new symptoms.