chrisvoncsefalvay/vaers-outcomes huggingface dataset:
"Janssen COVID-19 Vaccine EUA"  Patient was diaphoretic, feeling faint and reported blurry vision. Patient denied dizziness, shortness of breath or chest pain. Patient was assessed by medical doctor and registered nurse . 911 was called , EMS responded , EMS assessed and treated patient . Patient was discharged in stable condition.
I believe he tested for COVID after getting Pfizer COVID-19 Vaccine; I believe he tested for COVID after getting Pfizer COVID-19 Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I believe he tested for COVID after getting Pfizer COVID-19 Vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I believe he tested for COVID after getting Pfizer COVID-19 Vaccine. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Additional information: He tested for COVID after getting Pfizer COVID-19 Vaccine and he was treated with Paxlovid.  No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Information has been received from a physician concerning a "16 year old" female with unspecified medical history and allergies reported, who on 11-APR-2007 was vaccinated intramuscularly with a third dose of Gardasil (657621/0387U).  On 11-APR-2007 the patient experienced "lipodystrophy".  She had loss of muscle in her left deltoid where she received the vaccine.  The adverse event started as mildly red and it progressed to be muscle loss of 4.5 by 3.5 cm.  The patient went to see the orthopedic surgeon who confirmed the diagnosis.  The patient is now being referred to a plastic surgeon.  The outcome was reported as not recovered.  No product quality complaint was involved.  Additional information has been requested.
Fever, Chills, Nausea, Dizziness, Severe Headache
I had stroke like symptom. I my left side was numbness. I could not move my left leg or arms. I had face dropping. I went to the ER. They did EKG, MRI, and Chest x-ray, showed that I had a transient ischemic attack (TIA). They also did lots of blood work, normal results.
patient called saying that one day ago, she woke up with redness and swelling at her injection site that was hot to the touch. She was not running a fever.
Pt recvd vax & exp swollen glands, sore throat & red rash over cheeks; rash persisted for 4 wks & then slowly faded away;
This spontaneous report as received from a male patient of unknown age (who was also a company representative) via company representative, refers to himself. There was no information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies reported. On 05-FEB-2016, the patient was vaccinated with M-M-R II (lot#, therapy type, expiration date, dose and anatomical location were not reported; subcutaneously) and with VARIVAX (Merck) (lot#, expiration date, dose and anatomical location were not reported; subcutaneously). On 08-FEB-2016, the patient experienced chills and a fever. On 27-FEB-2016, he was diagnosed with pneumonia. The treatment was given and included antibiotic quinolone and an unspecified steroid. The physician also suggested bed rest. The outcome of the events was reported as recovering. The patient sought medical attention and visited physician and emergency room (name or location were unknown). The relatedness between the events and vaccination with M-M-R II and VARIVAX (Merck) was not reported. Additional information has been requested.
Information has been received from a nurse concerning a 66 year old female with no pertinent medical history and no known drug allergies who on 13-OCT-2008 was vaccinated with the first dose of PNEUMOVAX 23 (Lot#659199/1541U) IM right arm. After administration the patient experienced severe muscle pain in her right arm, "She would not let any touch her arm." She developed erythema of right arm with central induration at the injection site. The skin was warm to touch. The nurse considered these events to be disabling because the patient "is not able to drive". On the same day the patient also received influenza virus vaccine (manufacturer unspecified), but in the left arm. The patient sought medical attention and at the time of report on 16-OCT-2008, patient was not recovered. This is one of several reports received from the same source. Additional information has been requested. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
Headache, fever, fatigue, nausea, site pain, lasted about 12 hours.
shingles; 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 HERPES ZOSTER (shingles) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Graves' disease.    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 HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not provided. No treatment medications were not provided.
Redness and swelling of left upper arm began on 03/07/2002 with no pain, feels tight, some itching, feels warm to the touch according to client. Advised by the doctor to take Ibuprofen and use ice pack.
This case was reported by a physician via call center representative and described the occurrence of lyme disease in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 18th December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced lyme disease (serious criteria GSK medically significant). On an unknown date, the outcome of the lyme disease was unknown. The reporter considered the lyme disease to be unrelated to SHINGRIX. Additional details were provided as follows: Batch number and expiry date of vaccine were not available. The patient was diagnosed with lyme disease some time after she had received SHINGRIX. The reporter did not seemed to think it to be related.
had to cancel her case today because she showed up without covid testing and then tested positive in PACU. Can you add her on to 11/30/21? It's a Tuesday which should work for her dialysis schedule and will be 21 days after todays test. She will not require another covid test since she tested positive this time.
suspected vaccination failure; had them; get the shot every year; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the vaccination failure, shingles and inappropriate schedule of vaccine administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient received Shingles vaccine every year, which led to inappropriate schedule of vaccine administered. After receiving Shingles vaccine, the patient got shingles. The patient did not want them ever again. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Pt was given expired dose of Pfizer covid vaccine for ages 5-11.  It is recommended that Pt revaccinate as soon as they are able to. No adverse reactions.
This spontaneous case reported by a consumer, describes the occurrence of dyspnea (difficulty breathing), myalgia (soreness in his chest muscles) and pyrexia (fever) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 048A21A) for COVID-19 immunization. Concurrent medical conditions included atrial fibrillation. Concomitant products included Eliquis (apixaban) for an unknown indication. On Mar 23, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 24, 2021, patient experienced  dyspnea (difficulty breathing) and myalgia (soreness in his chest muscles). On Mar 25, 2021, patient experienced pyrexia (fever). On Mar 24, 2021, dyspnea (difficulty breathing) and myalgia (soreness in his chest muscles) resolved. On Mar 25, 2021, pyrexia (fever) resolved. Diagnostic results: On Mar 25, 2021, body temperature: (high) 100ºF. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown.
pt recvd vax & exp fever/irritability devel shortly p/;T103, gen sz lasting 5 mins in the evening; brought to ER where dx of febrile sz;had wnd gen sz in early morning lasting 1min
Patient left pharmacy after 15 minute observation period. Was reported that patient drank water, choked on it. Mom brought patient over to pharmacy saying that he was having trouble breathing and his skin was pale. Asked for me to call 911.  RN on site assessed patient until EMS arrived. RN  said that he sounded fine, but his heart rate was rapid. EMS did not take patient away and family left with patient.
Information has been received concerning a 9 year old male who was vaccinated at age 1 with a dose of varicella virus vaccine live. On approximately 4/18/03, at 9 years old, the patient experienced full blown chicken pox. Unspecified medical attention was sought. Additional information has been requested.
P/receiving Engerix-B 1 month ago APR92 pt exp bilateral swelling of both arms, myalgias, & still has swelling 30 days later (?6MAY92) in hands;
ADMINISTRATION ERROR : Patient was stuck twice during vaccination. Pharmacist told patient the first shot did not have vaccine, but second shot did. Patient believes he was vaccinated twice on 08/23/2021.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot # L013827 exp. 21-APR-2017, (dose and route were not provided). The vaccines were exposed to temperature of -11.9 C during 21 Hours. Then they were back in range. It was also stated that the vaccines were not previous exposed to any other excursion. No adverse effect was reported. Additional information has been requested.
Patient states began to develop the following symptoms 1-2 hours after vaccine administration on 9/23:  "heat & tingling sensation in left arm, chills, headaches, and "out of focus" vision.  Went to Urgent Care the evening of 9/25 with continued symptoms and red raised rash that was spreading on left arm.  States told FNP she felt like her breathing was rapid and felt like a "small weight" was on her chest.
Cellultic response 8 days after receiving the COVID vaccine; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, cellulitis.  The patient's medical history was not provided. Concomitant medication use was not provided by the reporter.  On an unknown date, the patient received the first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient developed cellulitis 8 days after receiving the vaccine. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, cellulitis, is considered unknown.; Reporter's Comments: This case concerns a female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted event of cellulitis.  Very limited information regarding this event has been provided at this time.  Based on the current available information and temporal association between the use of the product and the onset of the event 8 days after vaccination, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
Increase itching and rash on arm where vaccines were given. Benadryl cream prescribed by MD.
Patient reported shoulder pain persisting at least 8 weeks from administration date. Some days it feels fine and other days it does not. She is able to rotate it in a circular manner, but when she tries lifting that arm up (to remove clothing), that is when she feels the most pain.
Information regarding PREVNAR 13 was received from a healthcare professional regarding a 4-year-old male patient who experienced high fever, vomiting, and "he was a different kid". The patient received the first dose on an unspecified date. MEDICAL HISTORY: The patient's concurrent illness includes cochlea implant. PRODUCT DETAILS: Indication of PREVNAR 13 was immunisation (supplemental dose). Product was administered on an unspecified date. Dose regimen was 1 dose. CONCOMITANT THERAPY: Concomitant medications were not reported. EVENT DETAILS: The patient experienced high fever and vomiting. The child was sent for a neurological consult because "he was a different kid" (unevaluable event). Outcome was unknown. No additional information was available at the time of this report. Follow-up (16Nov2010): Following the integration of the legacy safety adverse event reporting databases, this case has been migrated from the legacy company database into the current safety database for processing follow-up information. As a consequence of the migration, the follow-up CIOMS I, Medwatch or VAERS may indicate in the appropriate field that it is an initial report. Follow-up attempts completed. No further information expected.
Pfizer-BioNTech COVID-19 Vaccine EUA: Vaccine recipient reported chest tightness during observation period. Vaccine recipient was monitored by EMS. No further intervention needed.
A little rash after first dose; This spontaneous case was reported by a consumer and describes the occurrence of RASH (A little rash after first dose) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced RASH (A little rash after first dose). In November 2021, RASH (A little rash after first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-403398 (Patient Link).
Cut himself; Headache; Dizziness; Weakness; Pain in the injected arm; This spontaneous case was reported by a non-health professional and describes the occurrence of WOUND (Cut himself), HEADACHE (Headache), DIZZINESS (Dizziness), ASTHENIA (Weakness) and INJECTION SITE PAIN (Pain in the injected arm) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Q27L2PA) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced WOUND (Cut himself), HEADACHE (Headache), DIZZINESS (Dizziness), ASTHENIA (Weakness) and INJECTION SITE PAIN (Pain in the injected arm). At the time of the report, WOUND (Cut himself), HEADACHE (Headache), DIZZINESS (Dizziness), ASTHENIA (Weakness) and INJECTION SITE PAIN (Pain in the injected arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.; Reporter'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.
Sore left arm; Felt as if vaccine went from shoulder through neck and to lips; Swelling of lower lip; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Felt as if vaccine went from shoulder through neck and to lips), LIP SWELLING (Swelling of lower lip) and PAIN IN EXTREMITY (Sore left arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Medical History is not provided by the reporter.  Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE HCTZ) and PREGABALIN (LYRICA) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PARAESTHESIA (Felt as if vaccine went from shoulder through neck and to lips) and LIP SWELLING (Swelling of lower lip). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore left arm). At the time of the report, PARAESTHESIA (Felt as if vaccine went from shoulder through neck and to lips), LIP SWELLING (Swelling of lower lip) and PAIN IN EXTREMITY (Sore left arm) 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.
48 days post first vaccine and has not received the second dose; Weak; Underweight; Nausea; Dry Heaving; Upper Respiratory Infection; Fainted; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant) and CHILLS (Chills). On 16-Mar-2021, the patient experienced UPPER RESPIRATORY TRACT INFECTION (Upper Respiratory Infection), DYSPNOEA (Dry Heaving) and NAUSEA (Nausea). On 12-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (48 days post first vaccine and has not received the second dose), ASTHENIA (Weak) and UNDERWEIGHT (Underweight). On 23-Feb-2021, SYNCOPE (Fainted) had resolved. On 28-Feb-2021, CHILLS (Chills) had resolved. On 06-Apr-2021, UPPER RESPIRATORY TRACT INFECTION (Upper Respiratory Infection) had resolved. On 12-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (48 days post first vaccine and has not received the second dose) had resolved. At the time of the report, DYSPNOEA (Dry Heaving), ASTHENIA (Weak), UNDERWEIGHT (Underweight) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She reported that she Fainted, and had chills, after the first vaccine. About 2-3 weeks after Vaccination she had an Upper Respiratory Infection with Negative COVID Test. She had Nausea, and Dry heaving since then. She feels Weak and Underweight. Today 12APR2021 and 48 days post first vaccine, She has not recovered from her upper respiratory infection. MD and Cardiologist told her to get the second vaccine. She wants to receive the second vaccine but she would like to delay it more, until she feels 100% well.  Patient had a pneumonia shot and Flu shot SEP2020.; Sender's Comments: This case concerns a 92-year-old female with a serious unexpected event of syncope, and nonserious unexpected upper respiratory tract infection, dyspnea, asthenia, underweight, inappropriate schedule of product administration and expected chills, nausea. Event onset the same day as first dose mRNA-1273. Events resolved. Based on 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.
now the rash on the shoulder area looks like an eczema; discomfort when touched at the injection site; big bump that has swollen at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of ECZEMA (now the rash on the shoulder area looks like an eczema), VACCINATION SITE DISCOMFORT (discomfort when touched at the injection site) and VACCINATION SITE SWELLING (big bump that has swollen at the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced ECZEMA (now the rash on the shoulder area looks like an eczema), VACCINATION SITE DISCOMFORT (discomfort when touched at the injection site) and VACCINATION SITE SWELLING (big bump that has swollen at the injection site). At the time of the report, ECZEMA (now the rash on the shoulder area looks like an eczema), VACCINATION SITE DISCOMFORT (discomfort when touched at the injection site) and VACCINATION SITE SWELLING (big bump that has swollen at the injection site) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication were not provided.
she awakened not feeling well and began ibuprofen. Yesterday am she began with nausea, no emesis, some fatigue and body aches. She feels worse today. Pt has the pain in her right back again and it is getting worse. She feels pressure in her belly and back on the right side, no bloating. The stool is brown and light yellow today, urine is yellow.
Mother called at 4pm & said baby had red dots all over her that she noted 1/2 hr ago. Denied itching.
Case was vaccinated x2 doses Mrna vaccine by 4/24/21, and was  hospitalized for covid in December 2021 and died of Covid 1/19/2022. Hospitalization and death occurred at hospital. Covid 19 pneumonia: treated with Dexmedetomidine, Titration, was intubated then extubated when improving. She deteriorated, and declined re-intubation, and died from respiratory failure.
Left arm was in pain and had soreness at time of administration on 12/10/2018. Between 12/10/2018 and 12/20/2018 soreness resolved, but pain still remained. Patient seen Dr. and he indicated shot was administered to high. Patient is taking Ibuprofen for the pain currently.