chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patch on my stomach/rectangular area on her stomach double the size of a stamp/woke up with a patch double the size of a stamp; This is a spontaneous report from a contactable consumer (patient herself). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EL9266; Expiration Date: 31May2021), via an unspecified route of administration, administered in Arm Left on 13Feb2021 between 8:45 and 9:00 as dose 1, single for COVID-19 immunisation. Patient medical history included Shellfish allergy, Nut allergy, Chocolate allergy (had the allergy for quite some time), High cholesterol and high blood pressure. Concomitant medications included Amlodipine 10mg and Hydrochlorothiazide 12.5 mg taken for high blood pressure, Rosuvastatin 10mg taken for High cholesterol, Colecalciferol (D3), Pyridoxine hydrochloride (B6) and multivitamin. The patient previously took Allegra as she suffers with hay fever. She didn't take Allegra the day she got the vaccine. She did not take any vaccinations within 4 weeks prior to COVID-19 vaccine. It was reported that, on 14Feb2021 between 7:30 and 8:00, the patient experienced patch on her stomach. She woke up with a patch double the size of a stamp. It is rectangular in shape. It is like a frame on her stomach on the right side. On the left side it is very faint and didn't completely come through. She reports that the area is not itchy and is not swollen. The patch has not worsened. It might of had a little improvement but she would say it has stayed the same. She has not visited the Emergency room or physician's office. The outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 75 years 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: 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: Unknown results; Negative, notes: Paxlovid rebound - after five days of Rx tested neg x 2; Positive, notes: tested positive for COVID. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical information: No other medication in 2weeks. No other medical history. This report was not related to a study or programme.
feeling miserable; Chills; Extreme tiredness; fever 101-102; severe aches; Exhaustion; This is a spontaneous report from a contactable nurse. A 59-years-old non-pregnant female nurse (Patient) received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 09Feb2021 09:30 (at the age of 59 years) as dose number unknown, single for covid-19 immunisation. Medical history included allergies to several antibiotics and covid-19 (prior to vaccination). It was reported that patient had not tested Covid Post Vaccination. Patient was not received any other vaccine in four weeks nor any medications in two weeks. There were no concomitant medications. On 09Feb2021, the patient experienced Exhaustion and Chills in the evening and severe aches keeping me awake most of the night, Extreme tiredness, fever 101-102, and feeling miserable most of Thursday. Patient ate soup at 5 and fine thereafter. Patient was not received any treatment for the events. On an unknown date, patient had recovered from all the events.  No follow-up attempts were possible; information about lot/batch number could not be obtained.
Received vaccine Monday. Sore arm immediately. Tuesday morning and afternoon is fine. Tuesday night, high fever,  chills & sweating, arm has a huge swollen lump at injection site, body aches (legs) and a headache. Took 500mg Naproxen and went to sleep. Woke up next day with all symptoms gone except the swollen, painful lump in my arm at the injection site, which I still have as of today, June 10th.  It's not getting any smaller. If the lump and pain doesn't go away by Monday, I will be visiting my doctor again.
Woke up in the middle of the night super nauseous. Couldn?t go back to sleep. Felt off the whole next day.... body aches, chills, nauseous, tired.   A week after the shot my arm was really itchy and had a giant welt. It also looked like it had hives on the bump.
Increased heart rate, pounding heart beat, woke in the middle of the night and fainted. Body shakes along with chills. Once passed went to the ER.
pt recv vax 4NOV96 & 5NOV96 pt devel a facial rash;pt recovered the next day;pt mom did not feel the rash was d/t vax since child had 2nd dose w/no problems;
Information has been received from a 25 year old female with a history of overgrowth bacterial and "ZIPORO" (therapy unspecified) allergy who in March 2009, was vaccinated with the first dose of GARDASIL. Concomitant therapy included neomycin, erythromycin, "Saczimin" (therapy unspecified), NASOCORT and NASONEX. In March 2009, the patient had a large bump on her arm after the vaccination. Afterwards the patient experienced swollen glands, headaches, nausea, rash, loss of breath and kidney stones and was hospitalized. The patient had an outpatient visit in April, 2009. Her physician diagnosed her as having a yeast allergy. She underwent a CAT scan, MRI and ultrasound (results not reported). At the time of report, the patient's status was not recovered. The health care professional contacted during telephone follow-up could not supply the following information: dates of vaccination, dose number, lot number, date of event, recovery status. Additional information has been requested.
Heat on the injection site; Soreness and heat on the injection site, and it also itches; Soreness and heat on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Heat on the injection site), VACCINATION SITE PRURITUS (Soreness and heat on the injection site, and it also itches) and VACCINATION SITE PAIN (Soreness and heat on the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     The patient's past medical history included Arthritis. Concomitant products included IBUPROFEN for Arthritis, VITAMINS NOS for an unknown indication.    On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced VACCINATION SITE WARMTH (Heat on the injection site), VACCINATION SITE PRURITUS (Soreness and heat on the injection site, and it also itches) and VACCINATION SITE PAIN (Soreness and heat on the injection site). At the time of the report, VACCINATION SITE WARMTH (Heat on the injection site), VACCINATION SITE PRURITUS (Soreness and heat on the injection site, and it also itches) and VACCINATION SITE PAIN (Soreness and heat on the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment includes anti-itching medicine (unspecified) and ice pack.
Information has been received from a physician concerning a 10 month old patient who in 2007 was vaccinated with "one tube x 3 doses", PO, of Rotateq. On 31 MAR 2008 the patient was hospitalized with intussusception which was surgically corrected. On an unspecified date the patient recovered from intussusception. Unspecified medical attention was sought. There was no product quality complaint. The event of intussusception was considered to be an other medically important event (OME) by the physician. Additional information has been requested. 7/2/08-records received for DOS 4/3-4/5/08-DC DX: Ileocecal intussusception. Sudden onset intermittant crampy abdominal pain began on 3/31/08 morning with passage of 1 dark stool without pain and none since. Subjective fevers.  Exploratory laparotomy with reduction of ileocolic intussusception and incidental appendectomy.
Fever; Chills; Chatter; Fatigue; Aches; Headache; This is a spontaneous report received from a contactable consumer (patient himself). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration at (upper) right arm on 16Feb2021 (Lot Number: EL9266) as single dose for COVID-19 immunisation. Medical history included patient had COVID-19 in the year of 2020 to 2020 (that's why he had such severe reactions). The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration at deltoid right on 26Jan2021 14:00 (Lot number: EL9262) for COVID-19 immunization and patient experienced chatter, fever, chills, fatigue, ache, headache, myalgia, malaise, asthenia, nausea, arthralgia, injection site pain, musculoskeletal stiffness, gait disturbance and feeling abnormal. The patient wants to report an adverse reaction to the COVID Vaccine and he had fever, chills, chatter, fatigue, aches, and headache on 16Feb2021. It happened with the first shot on 26Jan2021 and then it subsided after 4 days and then it happened again 16Feb2021 with the second shot. They are milder no more fever but some headache and some aches. The patient received just Tylenol for the treatment of events. Outcome of event fever was recovered on an unspecified date in 2021, for chills, chatter and fatigue was unknown and for aches and headache was not recovered.  Follow-up attempts completed. No further information expected.
Patient came to the ED with dyspnea, nausea, and diarrhea.  Patient admitted to hospital with Covid.
elevated HR, Chest pressure. HR still approx 125. -Evaluated by EMS- Cleared
some excursions were discovered with ROTATEQ; No other adverse events reported; This spontaneous report as received from a physician and his clinical research coordinator and refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies, previous drug reactions, allergies, historical drugs or medical history.      On an unspecified date, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) single dose, orally, lot # 1661000, expiration date on 13-MAY-2021 as prophylaxis (strength, dose, and frequency were not reported).        On unspecified dates, the administered dose of vaccine experienced the following temperatures of excursion: 1.6 degrees Celsius above the recommended storage for a maximum of 19 hours and 31 minutes; on a separate occasion it was exposed to 1.3 degrees Celsius above for a maximum of 16 hours and 49 minutes;  0.6 degrees Celsius above for a maximum of 22 hours and 56 minutes; and 0.6 degrees Celsis above for 22 hours and 56 minutes (Incorrect product storage). There was previous temperature excursion however it was not reported.
3 month old inadvertently received Kinrix; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 3 month old inadvertently received Kinrix). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 13-Apr-2023 The physician declined to provide more information. The permission for follow-up was not asked. The patient inadvertently received a dose of Kinrix within in the past few days at an inappropriate age, which led to inappropriate age at vaccine administration.
This case was reported by a pharmacist and described the occurrence of dizziness in a 58-year-old male subject who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix, GlaxoSmithKline) for prophylaxis.  Concurrent medications included unspecified pain medications.  On an unspecified date in July 2007, the subject received the 2nd dose of Twinrix (unknown).  On an unspecified date in July 2007 after vaccination with Twinrix, the subject experienced dizziness.  The pharmacist reported that the subject may not take the 3rd dose in the Twinrix series.  At the time of reporting the event was resolved.  The pharmacist considered the event was possibly related to vaccination with Twinrix.
75 y.o. Caucasian female with history of HTN, HLD, a fib not on anticoagulation, and recurrent falls at home culminating in a traumatic SDH complicated by uncal herniation and TBI in October 2021 with slow recovery in the interim, and recent candidemia who presents with shortness of breath in setting of known COVID infection.  Patient was hospitalized in January 2022 for sepsis secondary to aspiration pneumonia.  Hospitalization was also complicated by candidemia and dysphagia.  She was treated with standard antibiotics for pneumonia and a 2 week course of micafungin for candidemia.  Repeat blood cultures were negative.  Although she had previously been receiving nutrition via NG tube, after working with speech path ology she was was advanced to a soft diet with nectar thickened liquids.  She discharged to a nursing facility for ongoing care on 01/26/2022.
On 4/7/21, the 17 year old patient recieved the Moderna vaccine at the state vaccination site.
Arthralgia, Fever, injection site pain Narrative:  Employee reports injection site pain/discomfort, fever, joint pain, and a rash. Reports using Benadryl and ibuprofen for symptom relief. Has not recovered as of date of this report.  Other Relevant History:
Mom describes reaction occurred about 6 hours after Menactra given left eye swollen, itchy. Dad described hives, mother did not see rash, described redness from scratching give one dose of prednisone and Benadryl by dad, Seen today 12/02/2005 no rash or swelling noted.
Patient stated Left Arm was very sore after first Pfizer Covid-19 dose, extending up his neck on the left side. He stated arm was still sore at time for second shot (5/17/2021).  Patient opted to have SECOND Covid-19 shot given in RIGHT ARM. He also experienced a couple of days having nausea, vomiting, and diarrhea, concurrently.   Patient complained that his Psoriatic Arthritis became aggravated also after the first  shot also.   Pharmacist askedif he wanted the second Pfizer Covid-19 vaccination and patient stated he did. Pharmacist administered the second shot in the series in the other arm (right) from the first shot (left). Patient was asked to remain for 30 minutes, which he did, then left stating he felt fine.
Patient reports having first dose Moderna vaccine 4/29/21. She started to have left eyelid swelling 4/30/21 which has progressed to mild facial swelling, 2 small hives on forehead and generalized pruritus. Advised to continue taking Claritin. She cannot tolerate Benadryl due to side effects. Started on prednisone taper and advised to go to ED if sx worsen
Fever up to 102 x 6 days, fussy, rash-faint, splotchy on back, stomach on 8th day after vaccine. Fussy x 2 wks after previous PREVNAR 13 on 5/4/11.
Inflammation of mouth and gums started on 2nd day after 1st vaccination.  Mouth inflammation cleared in about 8 days.  Inflammation returned in May and has worsened.  Gums and front teeth are very sensitive. Some days are worse than others.  Front center right tooth feels loose off and on during the day.
This spontaneous report as received from a pharmacist refers to a 73 year old female patient with no pertinent medical history or drug reactions/allergies. On 16-APR-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # H018799, expired date 14-JAN-2015). On 17-APR-2013 the patient experienced swelling redness and tenderness at the injection site 24 hours after she was given ZOSTAVAX. The patient also stated she had body chills, dizziness and "chill bumps" all over her body. The patient came to pharmacist for medical attention. There was no treatment given for the events. No lab diagnostics studies performed. At the time of the report, the patient was not recovered from the events. The causality was not provided. Additional information has been requested.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 72-year-old female patient 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) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 10-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.).    No concomitant information provided No treatment information provided    Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live Non-Significant follow up
sudden death (?sids) 3 days p/DTP/OPV/HIB-no fever or any other sx following immun; autopsy done-results pending;
Discharge Provider: PA-C Attending Physician: MD Primary Care Provider at Discharge: DO  Admission Date: 5/5/2022 Discharge Date: 05/08/2022  PRESENTING PROBLEM: Acute respiratory insufficiency [R06.89] COVID [U07.1]   HOSPITAL COURSE: Patient is a 77-year-old male with a history of remote ischemic stroke without residual deficits, hyperlipidemia, GERD, depression, and anxiety who presented secondary to severe worsening generalized weakness.  About 5 days prior to admission, he began to notice worsening weakness, along with a mild cough, sore throat, shortness of breath on exertion, diarrhea, nausea, and vomiting.  He had received his COVID vaccination x2 and 1st booster in 10/2021.  On arrival, he was febrile and tachycardic.  He desatted on room air and was placed on 2 L nasal cannula.  Labs notable for leukocytosis, acute kidney injury, and COVID positive.  Chest x-ray clear.  He was given 1 L of normal saline, started on Decadron and admitted for further care.  Procalcitonin elevated at 13 for which he was started on a ceftriaxone and azithromycin.  Supplemental oxygen weaned to room air.  Additional fluids held on admission given COVID positive status, but creatinine down trended to baseline with encouragement of oral intake. OT evaluated and recommended discharge home.  He was discharged home in stable condition on 5/8/22.  He will complete a 5 day total course of antibiotics with remaining 2 days of Ceftin and azithromycin.  He was advised to arrange hospital follow-up with his primary care physician.
chills, fatigue, elevated temperature of 99.7 on day one that increased to 100.9 on day two
No adverse reaction at all, Patient came to get his flu shot, I asked him if he didn't get it for the season yet since its March, he said no. Then when I did add it to electronic read , I found out that he did got it in 10/17, I called him to let him know that, and to ask who is his Primary Care Doctor, he said he doesn't have any PCP, and no reaction at all.
have really itchy rash; This case was reported by a consumer via interactive digital media and described the occurrence of itchy rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was unknown.   It was unknown if the reporter considered the itchy rash to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received Shingrix vaccine and experienced itchy rash. The follow up would not be possible as no contact details were available.
Pt returned to clinic w/swelling, itching (almost blister) area abot 2.2, no edema outside that area; was sent to ER to be checked; no MD in clinic @ time pt presented; was seen in ER by nurse only; dark area where shot was given;