chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling of the face; hives; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swelling of the face) and URTICARIA (hives) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced SWELLING FACE (Swelling of the face) and URTICARIA (hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 50 milligram; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 25 milligram; PREDNISONE at a dose of 60 milligram and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SWELLING FACE (Swelling of the face) and URTICARIA (hives) outcome was unknown.            No concomitant product use was reported  Action taken with mRNA-1273 Moderna COVID-19 Vaccine is not applicable   This case was linked to MOD-2021-033957 (Patient Link).
Sore Arm,Aches, Chills, low fever, headache. Effects lasted approx 3 days
This spontaneous prospective pregnancy report as received from a pharmacist refers to an 18 year old female patient. The patient's concurrent conditions, medical history, drug allergies and concomitant medications were not reported. On 31-AUG-2018, the patient was inadvertent vaccinated with GARDASIL 9 (dose number, dosage, route of administration, anatomical site of vaccination, lot number and expiration date were not reported) for prophylaxis. No adverse events were reported. The patient became pregnant with Last Menstrual Period (LMP) of approximately 05-JAN-2018 and Estimated Delivery Date (EDD) of approximately 12-OCT-2018. Initial exposure to GARDASIL 9 was at 34 weeks.
pt recvd 1st dose of vax 10FEB92 & w/in a day of vax devel a local reaction which was not described; 5 to 7 days following vax, devel a rash, fever, & exp malaise & myalgia;
Immediate onset of focal pain upon injection of L lateral shoulder; injection was very proximal to tendon.
nauseous; dizzy; weak; General Malaise; vomited; tired; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), ASTHENIA (weak), MALAISE (General Malaise), VOMITING (vomited) and FATIGUE (tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21A) 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) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DIZZINESS (dizzy), ASTHENIA (weak), MALAISE (General Malaise), VOMITING (vomited), FATIGUE (tired) and HEADACHE (bad headache). On 22-Mar-2021, the patient experienced NAUSEA (nauseous). At the time of the report, DIZZINESS (dizzy), ASTHENIA (weak), MALAISE (General Malaise), VOMITING (vomited), FATIGUE (tired), HEADACHE (bad headache) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided. The patient fell off the toilet.Patient still felt nauseous on 22-Mar-2021.
Right Arm Swelling, Redness, Erythema, Bruising about 2 hours after admin
Breakthrough COVID case. Moderna Spikevax-MOD 100mcg . 1st dose 2/16/21, 2nd dose 3/18/21. Lot unknown.
Report completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 01/08/21 pfizer,Lot#EL3248 2nd dose: 01/29/21 Pfizer,Lot# EN5318 Diagnosed covid positive:08/10/21 Symptom onset:08/11/21 Exposure:Travel Symptoms:Fever, cough, fatigue, loss of smell/taste, sore throat , runny nose ,headache.
THE PATIENT RECEIVED THE EXPIRED VACCINE. SHE REPORTED SORE ARM AFTER VACCINATION.
Swollen lymph node left armpit, swollen arm, pain in armpit and left shoulder blade
Information has been received from a physician concerning an approximately 70 year old "over 60 years old" female patient who in September 2009 "1 year ago", was vaccinated with one dose GARDASIL injection (Lot# not reported). It was reported that in September 2009 "1 year ago", the patient experienced shortness of breath 35-40 minutes later when the patient contacted her physician. She then felt better and the shortness of breath subsided later the same day. The patient sought unspecified medical attention. No further information is expected.
Information has been received from a nurse who reported that some patients were administered improperly stored RECOMBIVAX HB 2.5 ug/0.5 mL (lot# reported as 0391AE, expiration date unspecified) and pneumococcal 14v polysaccharide vaccine (MARRS # 1210USA002676). RECOMBIVAX 23 was exposed to two temperature excursions, exposed to 10 degrees celsius for 72 hours and a day later, exposed to 12 degrees celsius for 48 hours. No adverse effects were reported. Specific number of patients was unknown. Additional information has been requested.
First on a rash below the vaccine site. Second Rash around vaccine site, fever, chills, arm very sore, fatigue and had to call into work.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration: 19-Aug-2021  Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2021-363245, MOD-2021-363032, MOD-2021-363226 (Patient Link).
PATIENT INDICATED SHE WISHED TO RECEIVE COVID19 VACCINE-MODERNA BOOSTER DOSE.  PATIENT HAD NOT RECEIVED INITIAL/SECOND DOSES OF ANY COVID19 VACCINATIONS; PATIENT RECIEVED 1/2 DOSE.  PATIENT WAS OBSERVED FOR 15MINS POST VACCINATION WITH NO ADVERSE REACTIONS NOTED.  PATIENT SEEN BY HER PROVIDER FOLLOWING EVENT.  NO ILL EFFECTS NOTED. PATIENT REPORTS NO ISSUES/CONCERNS POST VACCINATION.
Pt c/o losing sensation immediately upon administration. Redness developed at site. Reports temp 100.3 Evaluated in office 48 hrs later (R) thigh with redness extending to posterior aspect included & swelling & complaints & itching. Treated with prednisolone 15mg/5ml 1 tsp po qd x 3d. Talked with mom (FU).
hot/cold sensation; back is bothering her; dizzy when getting up from a chair; body aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (hot/cold sensation), MUSCULOSKELETAL DISCOMFORT (back is bothering her), DIZZINESS POSTURAL (dizzy when getting up from a chair), MYALGIA (body aches) and CHILLS (chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (hot/cold sensation), MUSCULOSKELETAL DISCOMFORT (back is bothering her), DIZZINESS POSTURAL (dizzy when getting up from a chair), MYALGIA (body aches) and CHILLS (chills). The patient was treated with IBUPROFEN at a dose of UNK dosage form. At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (hot/cold sensation), MUSCULOSKELETAL DISCOMFORT (back is bothering her), DIZZINESS POSTURAL (dizzy when getting up from a chair), MYALGIA (body aches) and CHILLS (chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported.  Benadryl is used as treatment medication.
A physician reported that a 10 year old female, post vax, developed a fever of 104 to 105F, chills, body aches, cough and nasal drainage. A dx of influenza was made; however, the type was not specified.
Got it after both shingrix doses/Suspected vaccination failure; Got it in arm; Hurts like a bugger; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 05-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got them in his/her arm after getting both Shingrix vaccines. The patient stated that hurts like a bugger but could be much worse. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Child began crying and continued to do so for two hours. She was hysterical and inconsolable. She complained of extreme leg aches and could barely walk. About an hour after the vaccines she broke out in pimples, which then turned into large welts, on her abdomen, back, and legs.
COVID test result as positive; COVID test result as positive; Chills; Body aches; Headache; Weakness; This is a spontaneous report from a contactable nurse (patient).  A 46-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: 49899, unknown expiration), intramuscular in right arm, in Dec2020 at 09:00 AM, at single dose, for COVID-19 immunization.  Medical history included asthma, hypothyroid, and interstitial cystitis.  The patient has no known allergies. Concomitant medication included influenza vaccine in right arm (lot number: US47SAA) on 08Dec2020 for immunization. Patient also received other unspecified medication within two weeks of vaccination. COVID-19 vaccine was administered in a hospital. On 23Dec2020 at 01:30 AM, the patient woke up with chills, body aches, headache and weakness. On 31Dec2020, the patient had nasal swab for COVID with COVID test result as positive post vaccination. Patient is not pregnant at the time of vaccination.  The patient did not have COVID prior to vaccination.  The patient received ibuprofen for the events chills, body aches, headache and weakness. The patient recovered from the events chills, body aches, headache and weakness on unspecified date; while unknown outcome for the remaining events.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 23Dec2020, and nasal swab for COVID-19 test positive on 31Dec2020.  No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the positive COVID likely represents the pre-existing infection prior to vaccine use.  Further information is needed for full medical assessment.
positive COVID-19 test with no symptoms; positive COVID-19 test with no symptoms; This is a spontaneous report from a contactable other HCP. A 93-year-old male patient received fist dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose by injection at arm for COVID-19 immunization. Medical history and concomitant medications reported as none. The patient was not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. The patient, nursing home had turned positive after the getting the vaccine. The patient was tested negative for COVID 19 before getting the vaccine on 18Dec2020, then took his first dose of COVID vaccine. The patient had no reaction to the vaccine. The patient got on the plane on 19Dec2020 and tested positive on 22Dec2020. PCR test for COVID 19 was done on 22Dec2020 and received the results on 23Dec2020 and it was detected(PCR test was positive). Event reported as non-serious. The patient still had had no symptoms before the test and none after the test came back detected. He was pretty healthy. It was unknown if patient would receive the second dose but he was scheduled to receive it. Patient was not admitted to an Intensive Care Unit. Patient did not display clinical signs at rest indicative of severe systemic illness. Patient did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. Patient had no any new or worsened symptoms/signs during the COVID-19 illness experienced (including date of onset/worsening). The patient did not receive any additional therapies for COVID-19. The event did not require the initiation of new medication or other treatment or procedure. Patient's outcome with COVID-19 reported as not currently ill. The outcome of the event was unknown. Information on the Batch/Lot number has been requested.; Sender's Comments: The patient received BNT162B2 on 18Dec2020 and took plane on 19Dec2020.  The patient was tested positive for COVID-19 on 22Dec2020.  The event occurred only 4 days after first vaccination and therefore the patient was not under full protection by vaccine.
pt recv vax 9MAY96 & same day pt devel high fever, noc sweats, dehydration, large swelling of all lymph glands, strange behavior & was talking to himself;11MAY96 all sx cont;hive-like swelling of the glands;made grunting sounds;dx autism;
Saturday: very sore arm, extreme fatigue, large painful lump in my left armpit (assuming it was swollen lymph node). Went away by Sunday, but then today (Thursday, August 29) almost a week after the vaccination, I woke up with a large patchy rash on my upper left arm (near the injection site); I do not know if this is related to the shot or not. It does not hurt or itch, but I thought I should report it so if others experience this, they will know others have too.  I still plan to get my follow up shot on November 1 regardless, better than getting Shingles.
Approximately 30 minutes after receiving the vaccine the following occurred: I began sweating profusely and coughing. I began coughing so hard, I could not catch my breath between coughs. I began feeling dizzy and light headed. This lasted for approximately 1 hour.
I got my first shot on 4/28. the week after my last period. My period was supposed to start on 5/17 and it hasn?t come. After my second dose on 5/19, I have no period but horrible cramps and abdominal pain/constipation.
I woke up the next day with a stomach ache, body ache, headache, elevated temperature (101.1). I felt dizzy, weak, and like my head was in a fog. I went to work but left about an hour later as I felt so awful. Most of the symptoms were gone in 24 hours, except for the stomach ache, which lasted another day. I have no idea who the manufacturer is of the Tdap I was given. The clinic gave me a CDC hand-out/info sheet that I looked at after I got sick and thought that it might possibly be from the vaccine. I get allergy shots and occasionally get some swelling at the shot location, but other than that, have not had a bad vaccine reaction that I can recall.
ARTHRITIS WORSENED; WIPED OUT ME OUT; RASH ON BOTH ARMS; This spontaneous report received from a patient concerned a 58 year old white not Hispanic or Latino male. The patient's weight, height, and medical history were not reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 17-MAR-2021 for prophylactic vaccination. The patient did not experienced any issues with the primary vaccination doses of covid-19 vaccine ad26. cov2. s (dose number in series 1). The patient received booster covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 213D21A, and expiry: 11-APR-2022) dose was not reported, 1 total, administered at left arm on 10-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  It was reported that after about two weeks of booster dose (in Dec-2021), the patient had developed a rash (up both arms, especially on the left arm where the shot was administered). The patient went to PCP (primary care provider) for treatment and was prescribed on 08-FEB-2022 tacrolimus Ointment 1% apply topically twice daily, Doxepin 25mg 1 Capsule three times daily. The patient stated that rash was not resolved. The patient stated that dermatologist prescribed these medications. On an unspecified date, the patient experienced arthritis worsened, rash and wiped out me out (all events with dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on both arms, arthritis worsened, and wiped out me out. This report was non-serious.
FATIGUE; PAIN IN INJECTION SITE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included pre-hypertension, and other 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: 1805018, and batch number: 1805018) dose was not reported, 1 total administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced fatigue. On 10-MAR-2021, the subject experienced pain in injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, and pain in injection site. This report was non-serious.
herpes in eye; This case was reported by a consumer via call center representative and described the occurrence of herpes ophthalmic in a 88-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On 7th October 2021, less than 5 months after receiving Shingrix, the patient experienced herpes ophthalmic (serious criteria GSK medically significant). The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the herpes ophthalmic was recovering/resolving.   It was unknown if the reporter considered the herpes ophthalmic to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient's wife.  The age at vaccination was not reported, but it could be 87 or 88 years. In June or July 2021, the patient received Shingrix in an unknown arm.  On 7th October 2021, the patient was diagnosed by the eye doctor with early herpes in the eye (unknown eye).  The eye doctor treated the early herpes with Valtrex for 2 weeks which was completed at the time of reporting.  The eye doctor reported that, the patient's eye looked good after treatment with Valtrex. The reporter did not consent to follow up. The reporter did not give permission for GlaxoSmithKline to contact healthcare professional.
Patient contracted COVID-19 after receiving  a single COVID-19 vaccine dose (Janssen completed on 4/12/21. Patient was admitted to the hospital on that same date for COPD exacerbation. Patient was exposed to a COVID-19 positive roommate and tested positive for SARS-CoV-2 on 5/25 and was treated with monoclonal antibody on 5/26/21. Patient remains stable and is currently hospitalized for bowel perforation s/p ex-lap, partial colectomy, colostomy and wound vac placement.
Nausea, vomiting, palor, diaphoresis, warm, dizzy, muscle contortion of immunized arm. Recovery time greater than 30 mins, less than 2 hrs. 20 oz Powerade given once nausea subsided.
Patient required hospitalization due to breakthrough infection. He received J&J vaccine on 03/12/21. Hospitalized from 08/18/21 - 08/30/21. Below is copied from discharge (death) summary:   Hospital Course:  HPI: Patient is a 70 year old male with a PMHx of COPD / Emphysema with home O2 dependence recently increased to 3L/NC, HFrEF, recent Dx of PE one month ago on Eliquis and depression who presented to the ED for worsening shortness of breath and hemoptysis. He is Covid positive and did receive the J&J vaccine. He was admitted to the Hospitalist's Service. He has worsening shortness of breath and increased oxygen demand and work of breathing. He is transferred to the ICU for increased level of care.    8/22: CTA Chest negative for PE but showed severe centrilobular emphysema, left lung apex cavitary lesion (infxn vs. Malignancy). Echo pending. Patient on BiPAP 10/5, 70% FiO2. No other concerns.   8/23: Holding off Baricitinib given concern for CAP. Given Lasix 40 IV x 1 and will resume home Lasix BID in AM for HFrEF. Currently on BiPAP 10/6, 80%. Weaning to HFNC +/- NRB as tolerated.   8/24: Pt with high level of anxiety prn yesterday for which Buspar was effective. He has been anxious overnight. Remains on HFNC.   8/25: Over day time transitioned to bipap with improvement in oxygenation. Reports no change in respiratory status.    8/26: Patient had several episodes of removing HFNC or BiPAP. Placed in restraints w/mittens on HFNC + NRB. Patient with more confusion recently as well. Started on Seroquel. Currently on HFNC + NRB 60L/100%.   8/27: Patient with confusion/agitation yesterday. CT head ordered but patient unable to cooperate even w/Ativan. Patient maxed out on Precedex gtt and still agitated. Added ketamine gtt w/improvement in sedation and patient able to tolerate BiPAP. NG placed.   8/28: Patient with increasing O2 demands last night, patient subsequently intubated and placed on PRVC.  Today, patient changed from PRVC to PS with improvements in oxygenation.  Patient on 14/10 75% PS satting mid 90's.   8/29: Overnight patients blood pressure dropping despite being on Levo and Vaso infusions.  Neosynephrine infusion added.  Bedside ultrasound performed showing ~50% collapse of IVC on inspiration - patient bolused 1L IVF with minimal improvement of blood pressure.  Patient with increasing O2 requirements.  ABG performed showing Hgb 6.5.  Patient type & screened, crossmatched, transfused 1u PRBC's.  Vancomycin added for broad spectrum antibiotic coverage.  Spoke with patients significant other who came in to the hospital to see patient - she confirms status of DNR with being ok for intubation.   1957:  Maxed on 4 vasopressors.  GCS 3T.  HR trended down to asystole.  No heart tones auscultated.  Time of death 1957.  Significant other notified.       Discharged Condition: deceased