chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 79 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 08-Sep-2016, the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Not reported. Batch number: WT53706. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 08-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. The patients will be contacted for revaccination.
employee presented to Covid Vaccine Clinic for 2nd Moderna vaccine. Following administration sx onset began at 0845:  dizziness, a feeling of a "headrush", feeling faint. 0846, BP 100/70, HR 85, shaky. "I just don't feel right, I can't describe it. I feel like my heart is racing, My head feels really weird. My throat feels like it has a little tickle but I can't be sure." NO h/o anxiety, panic, anaphylaxis. 900 am "my throat feels like it is swelling on the inside"
07/18/2003: 1.5 inch pink area at vaccination site left arm.  sore to touch and itches.  Low grade temperature 07/15 & 07/16.  07/22/03: Vesicle on stomach and small lesions on thighs.  Generalized itching.
This spontaneous report was received from a registered nurse refers to a male patient of unknown age. On an unknown date in April (date and year not reported) the patient was vaccinated with GARDASIL dose 3 (dosing regimen unspecified). Information regarding concomitant therapies was not reported. On an unknown date in April (date and year not reported) medication error reported that the patient received the third dose of GARDASIL in April which would have been only 3 months after his 1st dose and no adverse effects reported. There was no product quality complaint (PQC) involved. The outcome of medication error-received the third dose of GARDASIL in April which would have been only 3 months after his 1st dose was unknown. Additional information has been requested.
Blood pressure out of whack; Having headache everyday; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INADEQUATELY CONTROLLED (Blood pressure out of whack) and HEADACHE (Having headache everyday) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE INADEQUATELY CONTROLLED (Blood pressure out of whack) and HEADACHE (Having headache everyday). At the time of the report, BLOOD PRESSURE INADEQUATELY CONTROLLED (Blood pressure out of whack) and HEADACHE (Having headache everyday) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication was not reported.  The treatment information was not provided.   Reporter did not allow further contact
SWEATING; RESTLESS SLEEP; JOINT ACHES; HEADACHE; This spontaneous report received from a patient via a company representative concerned an adult male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. The batch number was not reported. the company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 10-MAY-2021, the patient experienced sweating. On 10-MAY-2021, the patient experienced restless sleep. On 10-MAY-2021, the patient experienced joint aches. On 10-MAY-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, restless sleep, joint aches, and headache on 11-MAY-2021. This report was non-serious.
vomiting; This spontaneous case was reported by a health care professional and describes the occurrence of VOMITING (vomiting) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced VOMITING (vomiting). On 10-Jan-2021, VOMITING (vomiting) had resolved.        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.   No relevant concomitant medications were reported. The patient did not receive any treatment for the reported event.; 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.
felt like a tetanus shot and was painful; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (felt like a tetanus shot and was painful) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (felt like a tetanus shot and was painful). At the time of the report, PAIN IN EXTREMITY (felt like a tetanus shot and was painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; 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.
pt recv vax 12JUL95 & @ 1030PM started w/hard crying that did not stop until 230AM; APAP given p/vax; no fever; no tx other than APAP;
Hives present on whole body.  Ran fever, Mother stated child was very fussy until next morning.  Mom stated fever was 101.6.  Gave tylenol as appropriate for age.
patient was sitting on bench in front of pharmacy and fell out of the seat onto the floor. Patient became very dizzy, flushed, and vomited. This happened about 10 minutes after vaccine given and lasted for about 10 more minutes. After throwing up, patient drank plenty of water and rested in which they started feeling good enough to walk away with their parent.
Initial misuse report received from a healthcare professional on 12 December 2013. The patient had received ACT-HIB. The vaccine was reconstituted with sterile water. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
became ill on 28OCT92 w/sore throat bilateral earache; no fever, cough, no rhinorrhea;
16 MINUTES AFTER VACCINATION PT WAS WALKING TO EXIT AND EXPERIENCED A FLUSHED FEELING, LIGHTHEADEDNESS AND HEART RACING. SYMPTOMS RESOLVED IMMEDIATELY. PT CONTINUED TO EXIT AND EXPERIENCED SIMILIAR SYMPTOMS AGAIN. PT ESCORTED TO MED OBS BY STAFF. SIGNIFICANT OTHER AT BEDSIDE. VITALS OBTAINED AND MONITORED. VSS. WATER GIVEN. SYMPTOMS RESOLVED. PT RELEASED TO HOME WITH SIGNIFICANT OTHER DRIVING AT 0851. PT ESCORTED BY STAFF TO EXIT WITH NO FURTHER ISSUES. VITALS AS FOLLOWS: 0842 LYING BP 140/94 HR 78 SPO2 99 0848 SITTING BP 128/83 HR 76 SPO2 100 0849 STANDING BP 132/84 HR 78 SPO2 100
Had two dot-like..spider bite looking bumps on right chest above nipples...next day small rash under right arm within the same horizontal line and the first two dots had exploded into tiny bumps......called pediatric office and was told to give Benadryl. The next day after was Jan 30 and was still not any better and there were two new dots on his back; so I called the pediatric office again and was told to come in. Did not see Dr. saw the Nurse and she diagnosed it as Shingles after she had a second opinion from another Dr....then they told me there was nothing else to do and sent me on my way with no further questions about my son or information about what to do.
PT into Medical Inprocessing Clinic today with reports of bilat upper extremity rash to include trunk. PT received Typhoid series dose #5 (May 2018 last updated), on Sep 14, 2021. PT at time vaccination denied prior adverse reactions to previous Typhoid. PT also denied current illness to include skin rashes at the time of vaccination. PT vital signs were stable, PT vaccinated with Typhoid without immediate reaction. PT left Medical Inprocessing clinic ambulatory. Upon return on Sep 15, PT was referred to our clinic PA for evaluation. PT was referred to his TMC,  Health Clinic to see his PCM or ER if he begins with increased symptoms. PT immunzation records were were updated to reflect Medical Permanent exemption to Typhoid vaccinations.
3" x 5" hard reddened area on the injection site.  The hardness dissipated after 4 days but the discoloration lasted 10 days.  There was also fever, severe chills, and body aches for the first few days.
Pt recv vax on 12/29/98; on same day pt exp pain/ red/ warm/ swollen/ hard vax site, fever, chills, headache, nausea, arthralgias
Vitamin D low; feet started hurting very bad; fingers started swelling; Might triggered rheumatoid arthritis; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4308882-00 (AbbVie).  A 57 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 02Apr2021 (Batch/Lot number: unknown) at the age of 57 years as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Lot number: 1155129) for rheumatoid arthritis. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 2021, outcome "unknown", described as "Might triggered rheumatoid arthritis"; VITAMIN D DECREASED (non-serious), outcome "unknown", described as "Vitamin D low"; PAIN IN EXTREMITY (non-serious) with onset 11Apr2021, outcome "recovering", described as "feet started hurting very bad"; PERIPHERAL SWELLING (non-serious) with onset 2021, outcome "unknown", described as "fingers started swelling". The patient underwent the following laboratory tests and procedures: blood test: vitamin d low. The action taken for upadacitinib was unknown. Therapeutic measures were taken as a result of vitamin d decreased.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available and known safety profile the events rheumatoid arthritis flare up, vitamin D decreased, pain in extremity and peripheral swelling are most likely due to an inter current or underlying condition hence assessed as unrelated to the suspect drug bnt162b2.
Pt. had cold sweats woke up, got out of bed and then passed out. (Unsure how long she was out) came to. Husband downstairs unaware. This happened more then 31 hrs after shots.
3/25/99 first Hep B. 4/26 2nd Hep B. 5/3 pt devel subcranial hemorrhage, contusions and subdural bleed. Considered OMIC. Additional info requested.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOTENSION HYPOXIA 2/24/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
I am allergic to the flu shot; This case was reported by a consumer via interactive digital media and described the occurrence of allergy in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced allergy. On an unknown date, the outcome of the allergy was unknown.   It was unknown if the reporter considered the allergy to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Flu vaccine and had allergy. The patient stated that cannot ever had another one.
Patient admitted to cardiac unit with new onset of A-fib. Patient has history of hypertension. Patient presented with "feeling weak and sick," vomiting, and palpitations. (Admitted on 4/2/03)
Sore arm; fever/Fever as high as 99.5 degrees Fahrenheit; fatigue/Tired like a wet dish rag; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache), PYREXIA (fever/Fever as high as 99.5 degrees Fahrenheit) and FATIGUE (fatigue/Tired like a wet dish rag) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B212A) for COVID-19 vaccination.     Concomitant products included INSULIN, LISINOPRIL, LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) and AZELASTINE for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced HEADACHE (Headache). On 26-Mar-2021, the patient experienced PYREXIA (fever/Fever as high as 99.5 degrees Fahrenheit) and FATIGUE (fatigue/Tired like a wet dish rag). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 27-Mar-2021, HEADACHE (Headache), PYREXIA (fever/Fever as high as 99.5 degrees Fahrenheit) and FATIGUE (fatigue/Tired like a wet dish rag) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Body temperature: 99.5 (High) Fever as high as 99.5 degrees Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications also included Pepcid patient had a roach test for antibodies at 4 months and the result was 626 IgG and on the 6 months on September 20th she took the same test and dropped 400 IgG. That was 6 months after my last shots. she still have antibodies.   This case was linked to MOD-2021-226911 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Significant follow-up: Patient test details added in Inarrative
chills; diarrhea; nausea; she was so sick and this caused her stomach to start acting; she was so sick and this caused her stomach to start acting; deathly ill; pain at the shot site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm right, administration date 24Mar2021 10:00 (Lot number: ER2613) at the age of 63 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Diabetic" (unspecified if ongoing), notes: Diabetic, from one year; "Gastroparesis" (unspecified if ongoing), notes: Gastroparesis, from 5 years; "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: FARXIGA taken for diabetes mellitus (ongoing); LEVOTHYROXINE taken for thyroid disorder (ongoing); LISINOPRIL taken for blood pressure measurement (ongoing); FAMOTIDINE taken for gastrooesophageal reflux disease (ongoing); REGLAN [METOCLOPRAMIDE HYDROCHLORIDE] (ongoing); NEXIUM 1-2-3 (ongoing).  The following information was reported: MALAISE (non-serious) with onset 24Mar2021, outcome "unknown", described as "deathly ill"; VACCINATION SITE PAIN (non-serious) with onset 24Mar2021, outcome "recovered" (26Mar2021), described as "pain at the shot site"; CHILLS (non-serious) with onset 25Mar2021, outcome "recovered" (25Mar2021), described as "chills"; DIARRHOEA (non-serious) with onset 25Mar2021, outcome "recovered" (26Mar2021), described as "diarrhea"; NAUSEA (non-serious) with onset 25Mar2021, outcome "recovering", described as "nausea"; ILLNESS (non-serious), ABDOMINAL DISCOMFORT (non-serious) all with onset 24Mar2021, outcome "unknown" and all described as "she was so sick and this caused her stomach to start acting".  Additional information: The events did not require a visit to emergency room and physician office. There were no prior vaccinations within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Approximately five days after the injection, I had my first period since 2013.  Due to a combination of pregnancy (delivered 2/2014) and subsequently two Morena IUDs, I have not even had spotting since 2013.  For three days, I had period-like blood and cramping.  I reported this during my routine rheumatologist appointment who told me to report it here. Additionally, I had pain in the arm for three days as expected from the literature about side effects from the trials.  I am scheduled to have my second dose on 2/4/21 and will report any other side effects.
Still (on and off) has Pain at the injection site and it is itchy and burns sometimes; Still (on and off) has Pain at the injection site and it is itchy and burns sometimes; Below injection site has red rash; GI symptoms (Abdominal pain) since getting the shot; Like a mild case of shingles; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced injection site itching, injection site burning, red rash, abdominal pain and shingles. On an unknown date, the outcome of the injection site itching, injection site burning, red rash, abdominal pain and shingles were not recovered/not resolved.   It was unknown if the reporter considered the injection site itching, injection site burning, red rash, abdominal pain and shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 11-JUL-2022 Reporter's comment: The patient received the vaccine late October- early November, but did not remembered exact date.  The patient received Shingrix vaccine in right arm. Patient still had (on and off) pain at the injection site and it was itchy and burned sometimes.  Below injection site, the patient had a red rash like a mild case of shingles.  The patient had gastrointestinal symptoms (abdominal pain) since getting the shot.   The consent to follow up was given.
8:31 Reported to us increased heart rate and tingling lips. Stated she had several allergies and brought her epi pen with her. Brought her to EMS station. 8:32 Gave epi 8:35 HR126 SPO2 100% 8:38 IV placed 8:39 POC 108 8:39 Benadryl 50mg IV push 8:40 Solumedrol 125 mg IV push Continued tongue/throat/ head itching 8:42 second epi given 8:46 136/64 HR 125 8:48 Transported to Medical Center via EMS
Fevers; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Jun-2021 and was forwarded to Moderna on 03-Jun-2021.    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 PYREXIA (Fevers) and CHILLS (Chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fevers) and CHILLS (Chills). At the time of the report, PYREXIA (Fevers) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. The treatment information was unknown.
Tested positive for Covid-19 a week later; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid-19 a week later) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced COVID-19 (Tested positive for Covid-19 a week later). At the time of the report, COVID-19 (Tested positive for Covid-19 a week later) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Covid Toes. My toes became red and inflamed and blistered like a bad burn with no pain after 13 days of getting the vaccine. The swelling went away after a week, but the discoloration of red and purple are still present after one week.
Initial report received on 05/Jun/2006 from a health care professional. A 19-year-old female patient who was recovering from nipple piercing had received a subcutaneous injection of Decavac, lot number U1587BA, in the stomach on 04/Jun/2006 at 07;30 am. Fifteen hours post-vaccination, the patient developed a sore abdomen with walts. The patient returned to the emergency room for evaluation. No relevant diagnostic tests or laboratory data were collected. At the time of this report, it was unknown if the patient had recovered from these adverse events.
DONOR REPORTED NECK SWELLED, COULD HARDLY TALK, EAT OR DRINK. WENT TO HOSPITAL ER 8/30/18 AND 9/1/18. WAS TOLD HE HAD REACTION TO TETANUS SHOT, BUT IT WOULD GO AWAY ON ITS ON. NO TREATMENT GIVEN.
Erythematous area on right leg/thigh 4 1/2" X 4 1/2". No cellulitis. No oozing. No fever and not warm to touch. Rx'd po Benadryl every 6 hours X 24 hours and po Advil. Follow-up as needed. Seen today for 1st time.