chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented to Healthcare on 8/4/2021 with unknown past medical history found to be hypoxic on EMS arrival, presents critically ill on mechanical ventilation in the Covid ICU.  Left lower extremity with severe mottling, cold to touch.  The patient continued on mechanical ventilation, developed worsening renal failure requiring dialysis, unable to be weaned from vent.  He had persistent metabolic encephalopathy d/t sepsis and Covid-19.  The patient did not improve after 2 weeks on the ventilator and the family decided to make him comfort care.  The patient was palliatively extubated and expired immediately thereafter.
There was no event that was an adverse reaction, patient received a pediatric dose of Hep B instead of adult dose.
Day after vaccine administered pt developed large firm palpable hematoma under injection site and had flushing to face in the early am.  Towards evening pt developed flu-like symptoms such as body aches, chills, nausea, and headache.  Symptoms persisted 3 days.
Pt presented with fever to 101 degree-103. Dx'd with clinical pneumonia and treated. Did not keep f/up or get testing done.
Erythema below site of injection, swelling and darker in color.  Calor and itching also present. Site about 3x3, just above the right elbow.
pt recv vax 31OCT97 & w/in 24hr p/vax pt exp aggravation of asthma & devel croup;pt was hosp 1NOV97 & tx w/corticosteroid therapy;
dizzy, feeling numb, convulsions per spouse. Evaluated by EMS-Refusal to transport.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No medical history, drug allergy and concurrent condition was reported. In 2013, the patient received first dose of ZOSTAVAX. Again on 23-FEB-2015, the patient was vaccinated with the second dose of ZOSTAVAX .65 ml, subcutaneous. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Patient presented with swelling of the lips and little redness of the face. No tongue or throat involvement presented. Patient said he might have reacted to something he might have eaten or the vaccines he received on 11/10/17. Patient said he normally gets these rxns with foods. Patient pick up BENADRYL but I strongly recommended that the patient should see a physician as soon as possible and to call 911 if condition worsens.
Information has been received from a medical assistant concerning a 16 year old female with a penicillin, sulfonamide and cefaclor (CECLOR) allergy who on 29-NOV-2006 was vaccinated with a dose of HPV vaccine (yeast).  It was reported that ever since she was given the vaccine, the patient experienced hot flashes and nausea.  Unspecified medical attention was sought.  At the time of this report, the outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
WE WERE MISINFORMED BY THE HEALTH DEPARTMENT REP THAT WE CAN ADMINISTER THE MODERNA VACCINE TO ANYONE YOUNGER THAN 18 YEARS AND WE GAVE THIS 17 YR OLD PATIENT THE MODERNA VACCINE.  SHOULD WE GIVE HER  THE SECOND DOSAGE?  WE WANTED TO KNOW WHAT SHOULD BE DONE? THE PATIENT HAS HAD NO REACTION TO THE VACCINE.
The cases were received on 21 March 2014. Initial misuse report received from a healthcare professional on 24 October 2013. The patient had received FLUZONE HD, and after some time the patient saw that the clear liquid running down the arm. It was an underdose. No adverse event was reported. List of documents held by sender: none.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known Allergy: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: AVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid as covid-19 treatment (start date Apr2022 and stop date Apr2022).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a licensed practical nurse refers to an 8 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-APR-2015, the patient was inadvertently vaccinated with a dose of GARDASIL, intramuscular (dose, injection site, lot number and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
This spontaneous report was received from a pharmacist refers to a 25 year old female patient. Current condition was reported as Crohn's disease. Patient had no known allergies. On 01-NOV-2014 the patient was vaccinated with GARDASIL, 0.5 ml (lot # and expiration date not reported), subcutaneously in the right arm instead of intramuscularly. No concomitant therapy was reported. On 25-NOV-2014 (reported as last week) the patient visited pharmacy and complained of skin irritation and bump at the injection site of right arm. No treatment was given for the adverse event. On an unknown reporting pharmacist stated that the patient was referred to her primary physician for follow-up. No product quality complaint (PQC) was reported. Outcome of the events were not reported. Causality assessment was not provided. Additional information has been requested.
Bad reaction...third booster; Very dark; Bruise/ 3 inches long and 2 inches wide towards breast/big bruise//really alarming, bruising/probably going toward my breast/3 inches from where it started to 2-2.5 inches high; Under my left armpit swollen lymph nodes/swollen lymph nodes underneath her armpit; Twelve hours after the shot, real bad chills; A little nausea; A very small fever like 99-something; Could not stop shaking; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Bad reaction...third booster), CONTUSION (Bruise/ 3 inches long and 2 inches wide towards breast/big bruise//really alarming, bruising/probably going toward my breast/3 inches from where it started to 2-2.5 inches high), SKIN DISCOLOURATION (Very dark), TREMOR (Could not stop shaking) and LYMPHADENOPATHY (Under my left armpit swollen lymph nodes/swollen lymph nodes underneath her armpit) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced TREMOR (Could not stop shaking), CHILLS (Twelve hours after the shot, real bad chills), NAUSEA (A little nausea) and PYREXIA (A very small fever like 99-something). On 01-Sep-2021, the patient experienced CONTUSION (Bruise/ 3 inches long and 2 inches wide towards breast/big bruise//really alarming, bruising/probably going toward my breast/3 inches from where it started to 2-2.5 inches high) and LYMPHADENOPATHY (Under my left armpit swollen lymph nodes/swollen lymph nodes underneath her armpit). On an unknown date, the patient experienced VACCINATION COMPLICATION (Bad reaction...third booster) and SKIN DISCOLOURATION (Very dark). At the time of the report, VACCINATION COMPLICATION (Bad reaction..third booster), CONTUSION (Bruise/ 3 inches long and 2 inches wide towards breast/big bruise//really alarming, bruising/probably going toward my breast/3 inches from where it started to 2-2.5 inches high), SKIN DISCOLOURATION (Very dark), TREMOR (Could not stop shaking), LYMPHADENOPATHY (Under my left armpit swollen lymph nodes/swollen lymph nodes underneath her armpit), CHILLS (Twelve hours after the shot, real bad chills), NAUSEA (A little nausea) and PYREXIA (A very small fever like 99-something) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported.   This case was linked to MOD-2021-311511 (Patient Link).
First dose Heart rate was up for a very long time. Went to ER had chest pain and breathing problems, started IV to get heart rate down gave Tylenol for swelling arm. Lump still comes and goes and burns at vaccine site.
No adverse effects were reported; The patient received MMR II and VARIVAX via intramuscular; This spontaneous report has been received from a pharmacist concerning to a patient of unknown age and gender.   The patient's concurrent conditions, medical history, past drug reactions or allergies and concomitant medications were not reported.  On 21-JUN-2019, the patient received Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live Albumin status of rHA (recombinant human albumin) (M-M-R II) injection (dose number, dose, strength and anatomical location were not provided)(lot#: R031628, expiration date: 01-NOV-2020); sterile diluent was used to reconstitute the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live Albumin status of rHA (recombinant human albumin) (M-M-R II) (lot#: S008564, expiration date: 05-AUG-2021); the patient also received varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (dose number, dose, strength and anatomical location were not provided) (lot#: S002738, expiration date: 28-JAN-2021), sterile diluent was used to reconstitute the varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot#: S012824, expiration date: 18-DEC-2021). Both vaccines were administered intramuscularly (incorrect route of product administration) as prophylaxis. No adverse effects were reported.
Pt recv vax on 11/3/98; 5-10 min later pt fainted, exp rigid body, jaw clenched, vomited
Client started experiencing eye pain 2/23/07 pm, a headache 2/24/07 and a temperature of 101.4. 2/26/07. Tc doctor-no further recommendations.
10jun-92 had DTP & HIB w/in a 1/2 hr began crying; stopped @ 8PM & went to sleep; t101 R; lt leg was swollen & red, wouldn't eat;
This spontaneous report was received from a certified medical assistant refers to a 81 year old female patient. Pertinent medical history included high blood pressure, high cholesterol, and hyperthyroidism. The patient had drug reactions/allergies to penicillin, PERCOCET, naproxen and IMITREX. Patient had taken unspecified concomitant medications. On 12-OCT-2015, the patient was vaccinated with PNEUMOVAX 23 lot # L003188, expiry date 06-JUL-2016, 1 vial, intramuscularly in the left arm. The patient came into the physician's office on 14-OCT-2015 with redness, swelling, pain and warmth at the injection site, in her left arm. It was unspecified exactly when the symptoms started. Reporter requested the lot check PNEUMOVAX 23 single dose syringes. The patient was given 300 milligram (mg) Clindamycin and 25 mg Clindamycin (unspecified frequency and unspecified manufacturer). Lab diagnostics studies performed were reported as none. The outcome of the events was reported as recovering. Causality assessment was not provided. The patient sought medical attention (by office visit). No product quality complaint (PQC) was involved. No further information was given. Additional information has been requested.
Patient developed swelling under the arm (armpit) and pain in the arm.  No redness or swelling around the site and movement in the arm was okay.
Adverse events experienced and are they still occurring now:  Patient called in stating she received the vaccine on Friday 5/21/21 @10:30 am and later she started to experience soreness at the injection site and about the evening time at 6pm she felt nauseous and started throwing up shortly after. She vomited about 5-6 times on Friday night. Saturday morning she woke up with soreness of the body in neck, shoulder body (extreme body aches), fever also started on Saturday. Patient also c/o headache, rash on left wrist (only area), and she also feels fatigued, and chills.   **Patient does have a history of blood clots and anemia**  She stated as of Monday 5/24/21 @7:26pm she had a fever in the day but that subsided after taking Tylenol. Last time the patient took Tylenol was on 5/24/21 at 2pm.
Itchy, raised, red, hard, roughly triangular area 4? X 4? X  3?. Worst (severe)for first 24 hrs then intermittent and moderate for next 5 days.  OTC Cortisone cream, 1% helped some. Redness mostly gone after 5 days.
Shot was quite painful and swelling was within 30 minutes.  Swelling continued until a large area in the muscle developed.  After approximately 2 weeks, my arm was nearly paralyzed.  I couldn't lift it away from my body.  It continued to worsen.  I couldn't sleep at night because of the severe pain.  I finally went to my doctor and he thought it might be a hemmatoma.  However, an ultra sound test did not confirm that.  I am presently in physical therapy to regain use of my arm.  The swelling is still there, but it has subsided.  I still experience pain and have a prescription that I find it necessary to use at night.  I did report this to the VNA
Two tone reddened area upper right arm. Lighter red area 75mm x 70mm with dark red area 35mm x 30mm. Slight itching, denia burning.
Follow-up information pertaining to therapy and event start dates and recovery status was received from the reporter.  Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was reported by a healthcare professional concerning a 6 year old male pt who experienced 13 hours of vomiting after receiving the vaccine on 12/12/03.  Relevant medical history was not provided.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/12/03.  Dose regimen was 0.5mL (IN).  Pt was not taking concomitant medications.  The pt experienced 13 hours of vomiting (vomiting) after receiving the first dose of Flumist on 12/12/03.  The pt recovered.  It was reported that the pt received injectable flu vaccine on 02/06/04.
VACCINE THAT WAS OUT OF THE TEMPERATURE WINDOW WAS GIVEN TO THE PATIENT. NO SIGNS OR SYMPTOMS WERE REPORTED OR OBSERVED.
This spontaneous report as received from a other refers to a three patients of unknown ages. On 17-AUG-2017, one unspecified patient was vaccinated with an improperly stored dose of ZOSTAVAX, and on 21-AUG-2017, two unspecified patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # M037015, expiration date 22-NOV-2017) for prophylaxis. Concomitant therapies included sterile diluent. No adverse effects reported.
Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 31 March 2014. A 19-year-old male subject, with no reported medical history, received ACAM2000 (lot not reported) and Influenza Vaccine (live intranasal, other manufacturer) on 13 November 2013. He had also received Anthrax vaccine (other manufacturer) on 04 November 2013. On 24 November 2013, i.e. 11 days post-vaccination, the subject was diagnosed with unspecified disease of pericardium. Laboratory test results were not available, and outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study.
develop rash at injection site; rash spread to chest and throat at 12 noon and then all over body including thigh; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash spread to chest and throat at 12 noon and then all over body including thigh) and VACCINATION SITE RASH (develop rash at injection site) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L30N) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced RASH (rash spread to chest and throat at 12 noon and then all over body including thigh). On 22-Jan-2021 at 10:15 AM, the patient experienced VACCINATION SITE RASH (develop rash at injection site). At the time of the report, RASH (rash spread to chest and throat at 12 noon and then all over body including thigh) and VACCINATION SITE RASH (develop rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
12/31/20 RT ARM PAIN, SAW PCP SAID IT WAS BICEP TENDONITIS AGGRAVATED BY COVID 19 VACCINATION,  MULTIPLE APPTS WITH PCP FOR CONTINUED RT ARM PAIN, ANTI-INFLAMMATORY PRESCRIBED,    AS OF TODAY, 2/10/21, IT IS SOMEWHAT BETTER (4/10 PAIN SCALE), TOLERABLE BUT STILL FRUSTRATING
Information has been received from a pharmacy student concerning a male patient who on an unspecified date was vaccinated SQ with a dose of PNEUMOVAX 23 (lot number not provided). The pharmacy student reported that the patient developed a reaction. The pharmacy student did not known the nature of the reaction. The patient sought unspecified medical attention. It was unspecified if any lab diagnostic studies were performed or if any treatment was given for the adverse event. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
LOWER BACK PAIN; GASTROINTESTINAL ISSUES; DIARRHEA; PAIN AT INJECTION SITE; NAUSEA; HEADACHE; FELT YUCKY; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: narcolepsy, heart issues, penicillin allergy, non alcohol user, non-smoker, and sulfonamide allergy, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, expiry: UNKNOWN) dose was not reported, administered on 12-AUG-2021 for prophylactic vaccination. Concomitant medications included hydrochlorothiazide for heart issues, lisinopril for heart issues, and pneumococcal vaccine polysacch 23v. On AUG-2021, treatment medications included: naproxen sodium. On 12-AUG-2021, the patient experienced felt yucky. On 12-AUG-2021, the patient experienced pain at injection site. On 12-AUG-2021, the patient experienced nausea. On 12-AUG-2021, the patient experienced headache. On 14-AUG-2021, the patient experienced gastrointestinal issues. On 14-AUG-2021, the patient experienced diarrhea. On 15-AUG-2021, the patient experienced lower back pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from gastrointestinal issues, diarrhea, pain at injection site, nausea, and headache on 15-AUG-2021, was recovering from felt yucky, and had not recovered from lower back pain. This report was non-serious.
Shortly after receiving vaccinations, pt developed somnolence progressing to lethargy and eventually obtundation. Pt admitted to PICU and an infectious/metabolic workup is ongoing (all essentially negative thus far). Labs demonstrate a mild to moderate inflammatory state however patient remains profoundly encephalopathic and is mechanically ventilated.
tiredness; a minor fever; muscle pain; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. In July 2020, unknown after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the patient experienced tiredness and fever. On an unknown date, the outcome of the muscle pain was not recovered/not resolved and the outcome of the tiredness and fever were unknown.   It was unknown if the reporter considered the muscle pain, tiredness and fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received Shingrix and experinced muscle pain, tiredness and a minor fever. The patient inquired what would do to alleviate them.
10/28/2022 @ 1325 Patient presented to the clinic complaining of redness on right arm that  was red and swollen and spreading and was painful and did not feel right on 10/27/2022. Reports that today on 10/28/2022 started to go away. This nurse and other examined right arm and very small spot-on arm had slight redness. Patient is on thyroid meds and no concerning health conditions. RN
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 32-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 10Aug2022 as dose 1, single (Batch/Lot number: unknown) at the age of 32 years for covid-19 immunisation. The patient had no relevant medical history. Date of last menstrual period: Jun2022. The patient was 12 weeks pregnant at the event onset. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on limited information in the case , a possible causal association between  all  the reported events ,Drug Ineffective COVID 19and the suspect drug cannot be excluded.