chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of erythematous rash in a 97-year-old female patient who received SHINGRIX (batch number C7B9P, expiry date 27th February 2021) for prophylaxis. On 22nd August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced erythematous rash. On an unknown date, the outcome of the erythematous rash was recovering/resolving. It was unknown if the reporter considered the erythematous rash to be related to SHINGRIX. Additional details were provided as follows: The patient experienced red rash 2 inches below the injection site. The rash was slowly lessening. On 25th August 2018, the patient came back with rash, it was not sure when exactly the rash started. This case has been linked with case US2018155212 reported by the same reporter.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 at 10:00 as dose 1, single (Lot number: EN6208), in left arm, on 31Mar2021 at 09:00 as dose 2, single (Lot number: EW0150), in left arm and on 07Oct2021 at 14:00 as dose 3 (booster), single (Lot number: FF2587) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 01Jun2022 at 11:00 as dose 4 (booster), single (Lot number: 056M21A), in left arm for covid-19 immunisation. No known allergies. The patient's relevant medical history was not reported. There were no concomitant medications. No other medication in 2weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
extremely tired; he was light-headed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 64 year-old male patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (Batch/Lot number: unknown) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Elevated blood pressure" (unspecified if ongoing), notes: He takes a blood pressure medication (unknown what medication) for elevated blood pressure.; "Prostate CA" (unspecified if ongoing), notes: two years for which he received radiation therapy, but no adjuvant chemotherapy.; "radiation therapy" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 16Mar2021, outcome "recovered" (17Mar2021), described as "extremely tired"; DIZZINESS (non-serious) with onset 16Mar2021, outcome "recovered" (17Mar2021), described as "he was light-headed".  Additional Information: It was reported that patient was light-headed and extremely tired. He has been working extremely long hours in tax preparation activities, which does involve face-to-face (with mask) interactions with clients. The lightheadedness and tiredness resolved completely within 24 hours.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
stomach ache that got worse ea day-turned into abdo cramps, nausea-vomiting went to MD; Friday purpura appeared, swelling & painful joints-Saturday couldn't walk; swelling inc w/purpura & abdo cramps-UTI-kidney maybe involved; dx purpura He
Discharge Provider: DO Primary Care Provider: MD Admission Date: 2/10/2023 Discharge Date: Feb 14, 2023  PRESENTING PROBLEM: Severe sepsis  Acute COVID-19 COVID-19 Pneumonia due to COVID-19 virus    HOSPITAL COURSE: 97-year-old male with past medical history of coronary artery disease, hypertension, hyperlipidemia, presented with fever, chills, shortness of breath and encephalopathy and found to have COVID -19 bilateral pneumonia.  Patient was started on Decadron.  Patient was placed on 2 L oxygen for mild hypoxia.  He was given 2 L of IV fluid bolus in the emergency department.  After admission, patient improved quite quickly and the next day his mental status was back to baseline, dyspnea resolved and his oxygen weaned off in the afternoon.  Two days later, he was placed back on 2 L of oxygen due to mild hypoxia down to 86% on room air.  Patient is asymptomatic and continues to feel well.  His PT and OT initially recommended discharge to subacute rehab facility but with patient's improvement, the change the recommendation to discharging home with home health care and family assist.  Patient was discharged home and to finish total of 10 days of Decadron on 02/14/2023
severe arm pain; Skin sensitivity at the injection site area; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe arm pain), SENSITIVE SKIN (Skin sensitivity at the injection site area) and FATIGUE (Exhaustion) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included HYDROXYZINE, PARACETAMOL (TYLENOL) and IBUPROFEN for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (severe arm pain), SENSITIVE SKIN (Skin sensitivity at the injection site area) and FATIGUE (Exhaustion). On 13-Mar-2021, PAIN IN EXTREMITY (severe arm pain), SENSITIVE SKIN (Skin sensitivity at the injection site area) and FATIGUE (Exhaustion) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications    This case was linked to -MODERNATX, INC.-MOD-2021-070028 (E2B Linked Report).; Sender's Comments:  -MODERNATX, INC.-MOD-2021-070028:Second dose case
shortly p/vax started itching on legs;devel eloped whelps all over legs similar to mosquito bites;
fever,chills, headaches, nausea,body aches, arm sorenes, redness and swollenes were shot was given,
Sore arm; Body aches; Mild headache; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 26Apr2021 at 11:15 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included gabapentin (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 05Apr2021 at 11:15 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. On 26Apr2021 at 21:00, 10 hours after the shot, the patient experienced sore arm, body aches and mild headache. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm, body aches and mild headache was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
The day following vaccine administration the patient developed a mildly pruititc facial rash and the day after that she developed diarrhea. After 2 more days symptoms were almost completely resolved.
Discomfort in armpits and breast?s.  Work in healthcare telling coworkers and they experienced the same. One had hers on the 17th same place (pharmacy).
Liver cancer after second dose 90 cist; Diabetes diagnosis/diabetic from a time that coincides whit the first shoot; High blood pressure (200); Lump Under Arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Jun-2021 and was forwarded to Moderna on 26-Jun-2021.    This spontaneous case was reported by a health care professional and describes the occurrence of HEPATIC CYST (Liver cancer after second dose 90 cist) and DIABETES MELLITUS (Diabetes diagnosis/diabetic from a time that coincides whit the first shoot) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HERBAL EXTRACT NOS, HOMEOPATHICS NOS (SIMILASAN), MONTELUKAST SODIUM (SINGULAIR), EPINEPHRINE and LORATADINE for Allergy, SALBUTAMOL (ALBUTEROL HFA) for Asthma, HYDROCHLOROTHIAZIDE for Blood pressure fluctuation, MULTIVITAMIN & MINERAL for an unknown indication.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced HEPATIC CYST (Liver cancer after second dose 90 cist) (seriousness criterion disability), DIABETES MELLITUS (Diabetes diagnosis/diabetic from a time that coincides whit the first shoot) (seriousness criterion medically significant), HYPERTENSION (High blood pressure (200)) and VACCINATION SITE LYMPHADENOPATHY (Lump Under Arm). At the time of the report, HEPATIC CYST (Liver cancer after second dose 90 cist), DIABETES MELLITUS (Diabetes diagnosis/diabetic from a time that coincides whit the first shoot), HYPERTENSION (High blood pressure (200)) and VACCINATION SITE LYMPHADENOPATHY (Lump Under Arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: abnormal (abnormal) Blood sugar was not under control.. On an unknown date, Blood pressure measurement: high- 200 (High) Blood pressure high. On an unknown date, Glycosylated haemoglobin: high (High) Diabetic.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication include CPAP machine used for Apnea. The treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not Applicable.  Company Comment: 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. Further information has been requested.   This case was linked to MOD-2021-237510, MOD-2020-001691 (Patient Link).; 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. Further information has been requested
skin irritated; skin inflamed; bleeding; bit of sore arm; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (skin irritated), DERMATITIS (skin inflamed), VACCINATION SITE HAEMORRHAGE (bleeding), MYALGIA (bit of sore arm) and INJECTION SITE PAIN (Injection site pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN IRRITATION (skin irritated), DERMATITIS (skin inflamed), VACCINATION SITE HAEMORRHAGE (bleeding), MYALGIA (bit of sore arm) and INJECTION SITE PAIN (Injection site pain). At the time of the report, SKIN IRRITATION (skin irritated), DERMATITIS (skin inflamed), VACCINATION SITE HAEMORRHAGE (bleeding) and MYALGIA (bit of sore arm) outcome was unknown and INJECTION SITE PAIN (Injection site pain) had resolved.            This case was linked to US-MODERNATX, INC.-MOD-2021-080392 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2021: New event and its outcome is added; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080392:dose 1
This is a 76y.o. female with obesity, sleep apnea, type 2 diabetes, paroxysmal atrial fibrillation, hypertension, hypothyroidism, tachy-brady syndrome with pacemaker, and chronic diastolic heart failure who presents with shortness of breath x 2 days. She feels it's been getting progressively worse. She also has bilateral lower extremity swelling. She also complains of dry cough, decreased appetite, and occasional nausea. No fever, chills, known exposures, or chest pain. Last 2-D echocardiogram in 2019 showed EF 60% and HFpEF.   Upon arrival to the ED, SpO2 was 89% on room air and 2 liters of supplemental oxygen applied. Chest x-ray concerning for CHF. BNP 51, D-dimer 458, troponin negative, procalcitonin 0.32. COVID-19 detected. The patient was admitted for further evaluation and management.
This case was reported by a nurse and described the occurrence of shingles in a 56 year old female subject who was vaccinated with Fluarix for prophylaxis. Medical history included non-smoker and "moderate" consumption of alcohol. On 11 October 2005 the subject received a dose of Fluarix in the right arm (lot number not provided). The nurse reported that the subject, "has had flu shots in previous years." On 11 October 2005, at an unspecified time following the administration of Fluarix, the subject experienced, "right arm pain." On 13 October, 2 days after vaccination with Fluarix, the subject experienced pain and itching of the arm, thigh, back and buttock "all on the right side of the body." The subject was seen at a physician's office on 14 October 2005, was diagnosed with shingles. The nurse considered the shingles to require clinical intervention (OMIC) and to jeopardize the subject. At the time of follow-up reporting, 09 November 2005, the shingles had improved, the arm pain resolved, and the "pain in the right thigh, back and buttock were still present." The nurse considered the events to possibly be related to vaccination with Fluarix and stated that, "the flu shot may have precipitated immune response, then the subject got shingles."
rash on his bilateral flank; This is a spontaneous report from a contactable healthcare professional (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced rash on his bilateral flank on 23Dec2020. It doesn't itch and within 24 hours was beginning to subside. The outcome of the event was recovering.  Information on the lot/batch number has been requested.
At 8pm on 123120 my left arm along with various other sites of my body were in pain. I also developed a bad headache at that same time. I still have the headache almost 24 hours later.
Swollen, tender lymph node to right armpit lasting all day Saturday.  The swelling improved with heat application and was gone by Monday
Came into the ER because of hypoxia, O2 in the 80s-90s. Her CRP is 20, Troponin is 0.143, BNP 208. Her only medical history is asthma, arthritis and hypertension.
Arm started being hot; Arm started being hard; Arm started itching; Arm started being red; Arm started aching and painful; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Arm started being hot), VACCINATION SITE INDURATION (Arm started being hard), VACCINATION SITE PRURITUS (Arm started itching), VACCINATION SITE ERYTHEMA (Arm started being red) and VACCINATION SITE PAIN (Arm started aching and painful) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Arm started being hot), VACCINATION SITE INDURATION (Arm started being hard), VACCINATION SITE PRURITUS (Arm started itching), VACCINATION SITE ERYTHEMA (Arm started being red) and VACCINATION SITE PAIN (Arm started aching and painful). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Arm started being hot), VACCINATION SITE INDURATION (Arm started being hard), VACCINATION SITE PRURITUS (Arm started itching), VACCINATION SITE ERYTHEMA (Arm started being red) and VACCINATION SITE PAIN (Arm started aching and painful) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. The patient's doctor told her to put a warm compress on the arm.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: NNI
Side effect for booster shot; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Side effect for booster shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effect for booster shot). At the time of the report, VACCINATION COMPLICATION (Side effect for booster shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were provided.
Pt. was given Adacel instead of Boostrix for her age. She was notified and also her physician. Pt. was not having any problems at the time.
Case number PHEH2014US023990, is an initial spontaneous report from a health care professional (medical assistant) received on 26 Nov 2014. This report refers to a 16-year-old male patient. Medical history and concomitant medications were not reported. The patient received only Men CWY liquid conjugate component of MENVEO (batch number: X13016) without being reconstituted with Men A lyophilized conjugate component intramuscularly on 26 Nov 2014. No adverse reaction reported following this medication error.
Information has been received from a physician assistant concerning unspecified patients. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. On unspecified dates these patients were administered improperly stored ROTATEQ (lot # M004883, expired date 02-DEC-2017 and lot # M025568, expired date 07-NOV-2017) (dose and frequency were unknown) oral. The rotavirus vaccine, live, oral, ROTATEQ was stored at 46.8 F for 4 hours 30 minutes. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
My body is magnetic after de first schot; 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 FEELING ABNORMAL (My body is magnetic after de first schot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (My body is magnetic after de first schot). At the time of the report, FEELING ABNORMAL (My body is magnetic after de first schot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment medications were unknown.
Pain in the heart, pain thoracic in retrosternal area. Fever, headache, malaise generalized.
sinus headaches; sore arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (sinus headaches), PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sinus headache (Patient had sinus headaches at baseline about 4 times a week ). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced SINUS HEADACHE (sinus headaches), PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue). At the time of the report, SINUS HEADACHE (sinus headaches), PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Pain on left side of body- from site of injection to fingertips, shoulder, left side of torso (began 12/31 late pm) Chills (began 1/1 in morning) Fever (began 1/1 in morning) Headache  (began 12/31 late pm) Nausea (began 1/1 late am) Dizziness ( began 1/1 late am) Night sweats ( began 1/1 late am) Muscle pain( began 12/31 late pm) Lack of appetite( began 1/1 early am) Heartburn( began 12/31 late pm) Tingling/ burning sensation when clothes touched skin (began 1/1 in afternoon)  Took tylenol every 4- 5 hours (500 mg); took dramamine (25 mg ) on 1/1, and on 1/2 24 hour increment;  Pushed fluids: water, Gatorade,  Temperature check every 6 hours.  Muscle pain, pain at injection sight, headache subsided 1/4 Chills, heartburn, lack of appetite, nausea, and dizziness subsided 1/3 Tingling/burning, fever, night sweats subsided 1/2
Sudden onset nonradiating chest pain 2/10 in severity. No diaphoresis no shortness of breath, no dizziness no difference upon exertion. Slight non productive cough. Sent ambulatory via ambulance to Emergency Room to rule out myo/ peri/ endocarditis.