chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Little bruises; Broke out in hives; Little red lumps in his hands, feet, legs and arms; Itching everywhere; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of URTICARIA (Broke out in hives), PERIPHERAL SWELLING (Little red lumps in his hands, feet, legs and arms), PRURITUS (Itching everywhere) and CONTUSION (Little bruises) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Exercise induced asthma (Caller is currently under no medical treatment.). Concurrent medical conditions included Drug allergy (allergic to ibuprofen).    On 13-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 URTICARIA (Broke out in hives), PERIPHERAL SWELLING (Little red lumps in his hands, feet, legs and arms) and PRURITUS (Itching everywhere). On 02-Feb-2021, the patient experienced CONTUSION (Little bruises). The patient was treated with PREDNISONE (oral) at an unspecified dose and frequency. At the time of the report, URTICARIA (Broke out in hives) and PRURITUS (Itching everywhere) had resolved and PERIPHERAL SWELLING (Little red lumps in his hands, feet, legs and arms) and CONTUSION (Little bruises) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient was between the age of 10 and 18 years. Pertinent medical history and drug reactions or allergies were not specified. On 14-MAR-2013, the patient was vaccinated with a dose of GARDASIL (dose in series unspecified) 0.5 mL, once, intramuscularly, lot number J006850, expiry date 31-MAR-2016 or J011272, expiry date 21-APR-2016, that was exposed to 30 Fahrenheit (F) for 10 minutes on 06-MAR-2014. No adverse effects were reported. This is one of several reports received from the same reporter (linked to MARRS # 1405USA008203, 1405USA0082972, 1405USA008973, 1405USA008974, 1405USA008975, 1405USA008976, 1405USA008977, 1405USA008978, 1405USA008979, 1405USA008980, 1405USA008981). Additional information has been requested.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 08-APR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK-0.5mlSD-PFS LLokwTip (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 720 hours with the lowest recorded temperature of 27 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
felt off; Chills; This spontaneous case was reported by a nurse and describes the occurrence of CHILLS (Chills) and ILLNESS (felt off) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 01-Mar-2021, the patient experienced CHILLS (Chills). On 18-Mar-2021, the patient experienced ILLNESS (felt off). Not Provided      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.   This case was linked to MOD-2021-028367 (Patient Link).
pt recvd vax 4NOV88 & 10DEC88 devel t102, anorexia, asthenia, myalgia & back pain; 15DEC88 cxr revealed lt lower lobe pneumonitis; 28DEC88 lab eval revealed SGPT 112, serum iron 30 & ESR 79; pt treated w/ASA; also exp pericardial effusion;
Lack of eye contact and reaction to sites and noises, would not use arms when typically he would reach for things. His body was just limp and uncharacteristically unresponsive. Warm bath given with mom while nursing and massaging baby trying to stimulate his arms torso and legs. Put a call into the dr and was told to monitor him. Roughly 12 hours later he  perked back up.
Red welt at injection site  about 48 hours after injection. Injection site is warm to the touch.
Initial report received from healthcare professional on 28 September 2013. A male patient in the 20's, whose date of birth, medical history and concomitant medications were not reported, had received intramuscular dose of ADACEL vaccine (batch number, dose number and anatomical site of administration were unknown) on 26 September 2013. It was reported that on 27 September, one day after receiving ADACEL vaccine, the patient experienced fever, arm pain and shaking in the arm. It was reported that, the fever was lessened. The patient received KEFLEX, Ibuprofen and advised to use compresses as a corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome was not recovered. Documents held by sender: none.
patient was hospitalized for cellulitis after receiving Twinrix; This case was reported by a pharmacist via call center representative and described the occurrence of cellulitis in a 67-year-old female patient who received HAB (Twinrix) (batch number 75C72, expiry date 13th June 2022) for prophylaxis.   On 2nd March 2020, the patient received Twinrix (intramuscular). On 4th March 2020, 2 days after receiving Twinrix, the patient experienced cellulitis (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the cellulitis was unknown.   It was unknown if the reporter considered the cellulitis to be related to Twinrix.  Additional information was provided as follows: The patient was hospitalized for cellulitis after receiving Twinrix.
initial reaction was redness and swelling at injection site very painful on Wednesday. by 1pm Friday noticed itching on left ear. by 2pm visible rash staring all over body.by midnight itching was out of control felt like my skin was crawling.it affected my head feet, palms of hands ,and entire body.  Pt has photos if need further review.
PULMONARY EMBOLISM W INFARCTION, UNSPECIFIED HYPOXIA
This case was reported by a nurse and described an 8-year-old male patient who did not respond to immunization with hepatitis B vaccine (manufacturer unknown). On unspecified dates, "starting at birth," the patient received a series of three doses of hepatitis B vaccine (manufacturer unknown). Subsequently, on 07 September 2004, a hepatitis B surface antibody titer was negative.
Chest and head tightness pale. EMS evaluated P90. O298% Lungs clear. Discharged home
Approximately 5 minutes after the patient received his vaccination, he rested his head on the wall behind him in the chair he was being observed in and passed out and turned white. His wife began slapping his face and screaming his name and the observer called for me. I arrived within seconds and assisted his wife in moving him from the floor to the chair. Within seconds of getting his head to the ground safely, he came back to and was very sweaty, red in the face. He stayed on the ground laying down, and then sitting for approximately 25 minutes. During that time, he told us that he had previously passed out during 3 procedures done at doctors offices.  We got him an ice pack and a orange pop as he was complaining of being hot and having only eaten a granola bar all day. He was able to get up to a chair and sat there for an additional 5 minutes, before he was able to walk out on his own accord. I have spoken with the patient twice since, once last evening and once today and he reports he feels great now besides the expected body aches from the vaccination.
AT INJECTION SITE, REDNESS AND WARM TO TOUCH. RX ZYRTEC BY DOCTOR AND TOLD TO GET RECHECKED IF NO IMPROVEMENT.
Approximately 6-8 weeks after my 2nd dose, i had breast pain and swelling, similar to the pain and tenderness I had when I was about to get my period, but more painful (I have been  post-menopausal for 2 years). This lasted from about mid-March to the end of April 2021. The pain went away but came back in about mid-July.  The pain has been worse this time around. It has been over a month. Tonight I began experiencing cramps similar to menstrual cramps.  Now I'm experiencing bleeding. I haven't had a period since April 2019.
red, swollen, painful rt upper anterior arm, a few hr p/vax;vax given tx w/ATB, DPH, & cold packs;
Fever of 100.5 for 6 hours, very bad headache for 24 hours, very lethargic for 24 hours, body aches for 36 hours, arm is still lightly sore but was very painful for 24 hours
bad rash all over her trunk of body, her back, her stomach, upper neck; red, scary looking and itchy and looks like chicken pox; then they turn on red and itchy; then they turn on red and itchy; Big bumps all over her back and stomach; This is a spontaneous report from a contactable consumer (consumer daughter). A 23-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Lot number: EL3248), via an unspecified route of administration on 29Jan2021 (age at the vaccination 23-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had a Pfizer vaccine on 29Jan2021 and since then she broke out in a bad rash all over her trunk of body, her back, her stomach, upper neck. So, patient called her workplace where she got the shot and they told her to come in for COVID test, although she knew did not had it because she had not been isolated. So, she came back negative, but her test is on Friday of this week. We do not know with all this rash, is it safe for her to get it. I just do not know; I mean it is pretty red scary looking rash, but it did not happen until like a day or so and then they turn on red and itchy and looks like chicken pox. After vaccination two day later, she got big bumps and it continued to get worst. Big bumps all over her back and stomach on an unspecified date in 2021 and her employer told her you have to take a COVID test. She did not have COVID because she was not exposed to anybody. So, she took the COVID test, and it was negative and Friday she has another vaccine appointment. Reporter stated, patient took treatment for the adverse events Benadryl and we have been rubbing Cortisone on it. The patient underwent lab tests and procedures which included Covid test: negative on an unspecified date. The outcome of the events was unknown.  Follow-up (14May2021): Follow-up attempts are completed. No further information is expected.
hives the noc of vax 18SEP97;examined 19SEP97 periorbital edema, urticaria & bronchospasm;pt also c/o being very tired;rx zyrter for urticaria;proventil;
Cough; Hyperosmia (cannot bare the smell of cooking); Tinnitus (wind whisper in his ear); Not sure if he has developed asthma because sometimes he feels like he is choking; Worried these symptoms are changing his life; fever of 103; Body aches; This spontaneous case was reported by a physician and describes the occurrence of COUGH (Cough), PAROSMIA (Hyperosmia (cannot bare the smell of cooking)), TINNITUS (Tinnitus (wind whisper in his ear)), CHOKING SENSATION (Not sure if he has developed asthma because sometimes he feels like he is choking) and ANXIETY (Worried these symptoms are changing his life) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 COUGH (Cough), PAROSMIA (Hyperosmia (cannot bare the smell of cooking)), TINNITUS (Tinnitus (wind whisper in his ear)), CHOKING SENSATION (Not sure if he has developed asthma because sometimes he feels like he is choking), ANXIETY (Worried these symptoms are changing his life), PYREXIA (fever of 103) and MYALGIA (Body aches). At the time of the report, COUGH (Cough), PAROSMIA (Hyperosmia (cannot bare the smell of cooking)), TINNITUS (Tinnitus (wind whisper in his ear)), CHOKING SENSATION (Not sure if he has developed asthma because sometimes he feels like he is choking), ANXIETY (Worried these symptoms are changing his life), PYREXIA (fever of 103) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: 103 (High) Fever of 103.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to he events were not applicable.   This case was linked to MOD-2021-023851 (Patient Link).
The patient experienced immediate localized swelling, heat and pain to the forearm. There was the appearance of greater than 10mm + PPD.
Information was received from a healthcare worker who reported that multiple unspecified patients were vaccinated with improperly stored GARDASIL 9 or VAQTA (lot numbers, expiration dates, dosages, and routes of administration not provided) on multiple unspecified dates. No adverse effects reported. No further information provided. Temperature: Unknown Time frame: Unknown Previous temperature excursion: No Data logger involved: Yes. Follow-up information was received from the healthcare worker on 17-MAY-2017 who reported that multiple unspecified patients were vaccinated with improperly stored ROTATEQ (lot #M044395, expiration date 31-MAY-2018) and GARDASIL 9, (lot #M034780, expiration date 15-APR-2019 and lot #M041212, expiration date 21-JUN-2019) on multiple dates between 24-MAR-2017 and 15-MAY-2017 (24-MAR-2017, 27-MAR-2017, 28-MAR-2017, 29-MAR-2017, 04-APR-2017, 07-APR-2017, 10-APR-2017 to 11-MAY-2017, 13-MAY-2017 to 15-MAY-2017). VAQTA was not given. No adverse effects reported. Temperature excursions were reported as follows: Time frame in 47°F to 77°F (9°C to 25°C) from 5 min to 3 hrs 25 min for a total of 70 hrs 50 min. Follow-up information was received from a nurse on 18-MAY-2017 who reported that GARDASIL 9 (unspecified lot number) was actually exposed to 47°F to 77°F (9°C to 25°C) for a total of 256.5 hours, which is a longer time frame than what was previously reported. No further clarifying information was provided. No adverse effects reported. Additional information has been requested.
pt recvd vax 17MAR92 & approx 2 1/2 hrs following vax devel rt facial palsy; seen by MD; 20MAR92 pt also c/o of some blurred vision in the rt eye & c/o that could not close rt eyelid; dx rt bell's palsy;
This spontaneous report was received from a office manager (healthcare worker) refers to a female patient of unknown age with none pertinent history. The healthcare worker reported that the patient was vaccinated with a first "standard" dose of GARDASIL, (dose route and Lot # not reported) in approximately 2010 (reported as about 2 years ago). In approximately 2010 (reported as about 2 years ago) the patient experienced numbness in both of her arms. The office manager was "recalling this from about 2 years ago." Verified with the representative that he learned of the event on 24JUL2012. It was reported that the patient did not continue therapy with GARDASIL because of the adverse event. It was also reported that the therapy was not reintroduced. The outcome of numbness in both of her arms was reported as recovered/resolved (recovery date was not reported). Additional information has been requested.
ITCHINESS; TINGLING OF FEET; RASH ALL OVER BODY; This spontaneous report received from a parent concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported 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 an unspecified date, the subject experienced itchiness, tingling of feet, and rash all over body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash all over body, itchiness and tingling of feet was not reported. This report was non-serious.
I tested positive for Covid-19 on 16Jun2022; I tested positive for Covid-19 on 16Jun2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6205), in left arm, on 30Mar2021 as dose 2, single (Lot number: EN6206), in left arm and on 17Oct2021 at 11:00 as dose 3 (booster), single (Lot number: FF2590) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE medically significant), COVID-19 (medically significant) all with onset 16Jun2022, outcome "not recovered" and all described as "I tested positive for Covid-19 on 16Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) positive, notes: My positive result was confirmed by multiple rapid tests over the next few days; (16Jun2022) positive, notes: I tested positive for Covid-19 on 16Jun2022 on a rapid antigen test; (21Jun2022) negative, notes: I tested negative on a rapid antigen test on 21Jun; (28Jun2022) positive, notes: on the morning of 28Jun I again tested positive on a rapid antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient stated this as a 'rebound' case. He tested positive for Covid-19 on 16Jun2022 on a rapid antigen test and began treatment with Paxlovid the same day. COVID 19 Treatment Paxlovid started from 15Jun2022 to 20Jun2022. His positive result was confirmed by multiple rapid tests over the next few days. His symptoms improved steadily and tested negative on a rapid antigen test on 21Jun, the same day he completed his final dose of Paxlovid. On the evening of 27Jun, some symptoms returned and on the morning of 28Jun he again tested positive on a rapid antigen test. Other medication within 2 weeks was reported as Nyquil, with start date on 15Jun2022 and stop date on 23Jun2022. No known allergies were reported.
Family brought patient to ER for "droopy left side of face" and that the left eyelid would not close.  ER diagnosis: Bells Palsy
Pt recvd 1st dose of Hep B  vax on 7JUN91 & approx 24 hrs following the vax pt devel nausea, diarrhea, vomiting, & chills; tx w/meds;
Chills, body aches all over, fever of 100.7F, severe head ache, extreme fatigue, abdominal cramping
17-year-old female client came into South Pod vaccination site for 1st dose of Pfizer COVID-19 vaccine. Patient was checked in appropriately. Pfizer 1st COVID-19 vaccine (0.3mL) lot # FP7138 was administered in the left deltoid at 1340 by  RN. Client was then asked to wait in the observation area for 15 minutes. Per report from the nurse , client reported feeling ?a little dizzy?  at the post-vaccination observation area. Client was offered  Zero gravity chair. Initial vitals were obtained at 1352 and recorded as follows; BP 128/70, HR 76, RR 16, Temp 97.9 degrees Fahrenheit, Oxygen saturation 99%.   Client was also provided with crackers and water. After 3 minutes of being in the zero-gravity chair, client stated ?I am fine, maybe I am just tired because I have been awake since 5 am?. Client reported that recent labs (2 weeks ago) noted that hemoglobin was low but she does not take any supplements. Client is alert and oriented x4 and verbally responsive. Client denies any pain, headache, blurry vision, difficulty breathing and shortness of breath. At 1358, vitals were obtained as follows:  BP 118/72, HR 78, RR 16, Temp 97.0 degrees Fahrenheit, Oxygen sat 99%. Client continued to deny any pain or discomfort. At 1406 repeat vitals were obtained as follows: BP 116/74, HR 64, RR 20 Temp 97.9 degrees Fahrenheit, Oxygen sat 99%.  Client was encouraged by the to continue drinking water offered earlier. At 1411, client stated ?I feel better, I don?t feel dizzy anymore, maybe I just got nervous in the hospital-like environment, maybe sensory overload.? The last set of vital signs was obtained at 1417, BP 110/72, HR 77, RR 18 Temp 97.3 degrees Fahrenheit, Oxygen sat 99%. Client was encouraged to continue drinking fluids after leaving the vaccination site.  Client was also encouraged by the nurse to follow up with Primary Care Physician as needed and to call 911 for shortness of breath, difficulty breathing and any other emergencies. Client verbalized understanding and left vaccination site at 1422. The incident was also endorsed to the job Corp representative who had accompanied the client. Client left the site with steady gait and balance
Approximately three weeks post vax, pt experienced arthritis type pain in her wrists, ankles and knees.  Pt was treated with feniprofam 600 mg three times a day.
Itching on the arm; It just feels a little stiff; Itching on the arm; It just feels a little stiff; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  An 85-year-old patient received bnt162b2 omi xbb.1.5 (COVID-19 VACCINE OMI XBB.1.5 - MANUFACTURER UNKNOWN), as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation; tafamidis (VYNDAMAX), (ongoing). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown" and all described as "Itching on the arm; It just feels a little stiff". The action taken for tafamidis was dosage not changed.  Additional information: A patient on the line was taking the medication Vyndamax and reported an itching just on top of the arm. It might have been an injection (COVID Vaccine) that the patient took about four weeks ago for a COVID (Manufacturer name not clarified, hence tab left unchecked). It was just itching in arm and just felt a little stiff or something. The patient just wanted to make sure, the pill the patient was taking Vyndamax was an Amyloid. Further probing could not be done as the consumer was unwilling to file a safety report. Thus, product details and pharmacy details were unknown. Hence, limited information is available over the call.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Had the shot on Monday, February 18. By Thursday, February 21, became totally exhausted, waves of fever and sweats, headache and muscle ache. On Friday, I had nausea and diarrhea, which continued for 4 days, coupled with vomiting and continuation of previous symptoms. On Sunday, red rash erupted on my chest. Developed chest congestion and severe coughing, difficulty breathing and sleeping. Spent Thursday through Tuesday in bed, exhausted. Finally went to emergency room on Tuesday evening when symptoms were not improving. At this time, one month after the shot, my stamina has not returned and the congestion and cough persist.