chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Nauseous; Tired; Sore; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for a 18-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration, administered in Arm Left on Jul2021 as DOSE 1, SINGLE for COVID-19 immunization. Medical history included COVID-19 from 17Mar2021 to an unknown date, cough, choking, headache, fatigue, decreased appetite, sensory loss, von willebrand's disease; patient was a carrier from an unknown date and unknown if ongoing. There were no concomitant medications. Patient's medical history: (including any illness at time of vaccination) was none. AE(s) following prior vaccinations was none. Family Medical History Relevant to AE(s): mother has Von Willebrand disease, patient was a carrier. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Prior Vaccinations (within 4 weeks): HPV in Jun2021 more than 4 weeks before. It was reported that on an unspecified date in Jul2021 the patient had experienced a headache; was nauseous; very tired, felt completely out of it; and had a sore arm for 24 hours. Adverse event did not require a visit to emergency room or physician Office. This was a clone report is created to document the son's experience. The patient underwent lab tests and procedures which included SARS-COV-2 antibody test: positive on 18Mar2021. The outcome of all events was unknown.The outcome of all events was unknown.
This spontaneous report as received from a medical assistant refers to a patient of unknown age.    On an unknown date the patient was vaccinated with ROTATEQ lot # N000172, oral for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ.
lump in armpit; it got a little swollen but in the opposite side of the body where the vaccine was administered; a pain started right below her armpit; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN8730), via an unspecified route of administration on 23Mar2021 at the age of 32-year-old as dose number unknown, single for covid-19 immunisation. Medical history included Prediabetes (probably around 5 to 6 years ago) and anxiety from an unknown date and unknown if ongoing. Concomitant medications included metformin taken 500 mg once a day  for Prediabetes, start and stop date were not reported and sertraline hcl taken for anxiety, start and stop date were not reported.  On 30Mar2021 the patient experienced a pain started right below her armpit and it got a little swollen, also noticed that have a lump in armpit but in the opposite side of the body where the vaccine was administered. She is worried whether she has to consult her physician about this (swollen in the opposite side of the body) or not.  Patient was concerned if its because of the vaccine or do I get it checked. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Diagnosed with shingles on 10/7 at urgent care.  Ophthalmology visit on 10/7 due to shingles near eye.  Visited ED on 10/9 due to status of shingles.  Still in treatment, but getting better.    Unknown if related to COVID vaccine.
Vaccine administered to patient not within approved age range. Vaccine administered in error. No adverse reaction occured.
Vaccine was administered as if it had a preservative; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered as if it had a preservative) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered as if it had a preservative). On 07-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered as if it had a preservative) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was given.  No treatment medication was given. Time from first puncture was 21 days.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up received contains no new information.
Fever for 2 days, body aches for a week now, headache for 4 days, sore throat, sneezing for 1 week, fatigue for 1 week, irritability for 5 days
This spontaneous report was received from a physician assistant regarding an 17 months old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 04-JUN-2018, the patient was inadvertently given a dose of PNEUMOVAX 23 intramuscular route for prophylaxis (strength, frequency, lot# and expiration date were not reported) instead of PREVNAR 13. No product quality complain was present.
Systemic: Fainting / Unresponsive-Mild, Additional Details: pt began feeling light headed about 5 minutes after recieving the vaccine. he began to get sweaty and loss of consciousness. i sat him down on the floor and gave him a water at which he immediately started feeling better. took pts bp: 115/76 hr:88 osat:99. pt felt perfectly fine after and at that point mentioned he didnt eat anything that day and fainted once giving blood. called pt couple hours later and stated that he felt perfectly fine;
Positive COVID test and symptomatic infection Client began feeling ill on 4/23/21 with a sore throat and some shortness of breath. Other symptoms include dry mouth, congestion, loss of taste and smell, and nausea. I spoke with the client on 5/1/21, she was still having slight symptoms, but over the worst of her illness. She did not need to seek medical care at any point in her illness.
sharp pain under her arm/a very sharp piercing pain in her armpit, under the same arm that she received the injection in; soreness in the injection site; it was so swollen that she couldn't feel the pea size lymph node; The caller's armpit on the side where she had her injection it was throbbing; tenderness; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 1 via an unspecified route of administration on 26Jun2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported, she got her first dose of the Pfizer Covid 19 vaccine last 26Jun2021. Day after her first dose she woke up with a sharp pain under her arm. She said that when she researched it, she thinks that it swollen lymph node. There was pain and tenderness. She took Advil. Each day it got better and it was almost gone after 2 weeks. By the day that she was scheduled to get her second dose the lymph node went to her other arm. She stated that her arm was super sore arm when touching. It got better each day and now it's okay. The caller also had a very sharp piercing pain in her armpit, under the same arm that she received the injection in. The caller researched it and it may have been a swollen lymph node but everything she read said it may be tender and you may feel it. But for the caller, it was so swollen that she couldn't feel the pea size lymph node. At about 2 weeks the caller's armpit was tender when she touched it. 3 weeks after the first dose, the caller had a pain on the other side under her arm. The caller was nervous to get the second dose because of this. The soreness under her opposite arm wasn't as bad and subsided each day. The caller's armpit on the side where she had her injection it was throbbing. A few days before the caller was scheduled for the second dose her opposite armpit was very tender but not as sharp and piercing and she could feel the pea. Outcome of events was recovering.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Feet  swelling; Ankle swelling; Face swollen; swell all over his body; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (Feet  swelling), JOINT SWELLING (Ankle swelling), SWELLING FACE (Face swollen) and SWELLING (swell all over his body) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 016B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL and OMEPRAZOLE for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced PERIPHERAL SWELLING (Feet  swelling) (seriousness criterion hospitalization), JOINT SWELLING (Ankle swelling) (seriousness criterion hospitalization), SWELLING FACE (Face swollen) (seriousness criterion hospitalization) and SWELLING (swell all over his body) (seriousness criterion hospitalization). At the time of the report, PERIPHERAL SWELLING (Feet  swelling), JOINT SWELLING (Ankle swelling), SWELLING FACE (Face swollen) and SWELLING (swell all over his body) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient stated that he works from home an noticed his feet and ankle swelling after receiving the vaccine. He reported taking a picture with his grand baby and noticed his face was swollen as well about a week after receiving the vaccine. Patient states his symptoms lasted on and off for a month. He received the second vaccine on 10-May-2021 in the left arm, (LOT 016B21A) and reported that he immediately began to swell all over his body and that the swelling was so bad he could not put a shirt on and he could not see his ankles. The patient was rushed to the Emergency room and hospitalized for treatment. He knows that he was given steroids and diuretics and states his symptoms are ongoing but that he did experience sporadic remission while hospitalized. He reported that his symptoms lasted on and off for a month.  Additional treatment included taking 80 mg of Prednisone for 10 weeks.  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.; 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.
Patient is a 76-year-old male with a history of coronary artery disease, prior MI, congestive heart failure with prior CABG and AICD placement. Patient is also oxygen dependent COPD and suffers from depression. He presents to the emergency room by EMS complaining of increasing generalized weakness, cough and shortness of breath over the last 4 to 5 days. He does state that several family members at home had for similar symptoms. He thought it was just a cold but it seems to be getting worse. Patient was vaccinated for Covid however it was approximately 8 months ago and he has not received a booster. Comfort to the anterior chest with coughing and deep inspiration. He was noted to have pulse oxygenation of 78% when EMS arrived at the house. Patient was 88% in the emergency room on 5 L nasal cannula. Associated Symptoms: appetite changes, back pain, chest pain, cough, depression, dizziness, fatigue, headache, joint pain, nausea, neck pain, shortness of breath, weakness, wheezing
This spontaneous report as received from a Nurse Practitioner refers to a male patient of unknown age with no drug reactions or allergies and a medical history of previous smoker. In approximately 2006 (5 or 6 years ago) the patient was vaccinated with dose 1 PNEUMOVAX23 (dose, route and lot # not reported). On unspecified date, the patient was vaccinated intramuscular with 0.5 ml dose 2 PNEUMOVAX23 (lot # 1420AA exp: 11-APR-2013). Concomitant medications included: FLUZONE. The nurse practitioner reported that on unspecified date, a patient developed warmth, redness and swelling of his right arm at the injection site after receiving PNEUMOVAX23. The patient also developed a fine, pink, papular rash on his upper chest after receiving PNEUMOVAX23. The nurse practitioner stated that this patient had received a dose of PNEUMOVAX 5 or 6 years ago, and experienced no problems. The patient was put on treatment with over the counter antihistamine (unspecified) and over the counter analgesic (unspecified). The patient sought medical attention by having a office visit. Laboratory and diagnostics were not performed. The outcome of adverse events was unknown. The relatedness for all adverse events was unknown for PNEUMOVAX23. Additional information has been requested.
Dizziness, vomiting, high respiratory rate (24), high heart rate for hours (above 120)
Redness at the injection site like an amoeba; Throat issues /doesn't feel right; Stomach issues or doesn't feel right; Feel fatigue; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 75-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 07-SEP-2023, the patient received Arexvy (left arm). On 07-SEP-2023, less than a day after receiving Arexvy, the patient experienced injection site erythema (Verbatim: Redness at the injection site like an amoeba). In SEP-2023, the patient experienced throat discomfort (Verbatim: Throat issues /doesn't feel right), stomach discomfort (Verbatim: Stomach issues or doesn't feel right) and fatigue (Verbatim: Feel fatigue).  The patient was treated with non-drug therapy (Ice Pack (No Medication)). The outcome of the injection site erythema was resolved and the outcome of the throat discomfort, stomach discomfort and fatigue were not resolved.   It was unknown if the reporter considered the injection site erythema, throat discomfort, stomach discomfort and fatigue to be related to Arexvy.     It was unknown if the company considered the injection site erythema, throat discomfort, stomach discomfort and fatigue to be related to Arexvy.   Additional Information: GSK Receipt Date: 12-SEP-2022 The patient was self-reported this case. The patient reported that she received Arexvy vaccine and experienced redness at the injection site that looked like an amoeba and it resolved after putting ice on the site.  A couple of days ago patient stated that her throat and stomach does not felt right.  Patient also stated that she started to feel fatigue.  These symptoms had not yet resolved. The reporter did not consent to follow up.
abdominal pain, diarrhea, constipation, malaise, fatigue, fever, headache, myalgia, nausea, pharyngitis, vomiting, vision changes (halos, blurry) all ongoing since 1/21/21  Feels like she has to blink her eyes to focus because her eyes are crossing, feels pressure in her ears. Went to PCP and received steroids. Went to another doctor and received vitamin D, magnesium, Coenzyme Q10, and Emergen-C. Denies sick contacts or bad/spoiled food intake  Covid testing done and negative, routine lab testing done including serum drug screen (only abnormal blood work was an elevated liver enzyme, positive for marijuana and benzodiazepines. elevated absolute lymphocyte, and vitamin D deficiency ), given zofran, Tylenol, Zyrtec, and Flonase and the Health Clinic
itchy on her arm; red on her arm; rash on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy on her arm), ERYTHEMA (red on her arm) and RASH (rash on her arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Muscle atrophy.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, 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 PRURITUS (itchy on her arm), ERYTHEMA (red on her arm) and RASH (rash on her arm). At the time of the report, PRURITUS (itchy on her arm), ERYTHEMA (red on her arm) and RASH (rash on her arm) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by investigator  No treatment medications provided by the reporter.
On Monday August 13th client received vaccines with no complications.  Denies prior reactions.  Next morning he slept two extra hours and woke up feeling nauseated.  He had dry heaves.  Mother gave him something to eat and he felt better.  Today he developed a large welt appoximately 2in wide and 2 across "bigger than a golf ball" on his arm- where he received two of the vaccinations - Arm is warm and sore to the touch.  No further symptoms noted.  Client feels "ok"
The night of the vaccine, she developed a fever and woke up. She has had a fever ever since the vaccine. She is lethargic and will not eat. I took her to the urgent care on 7/8/2022. She had a strep and COVID-19 test that were negative. Her highest fever was 104. I also took her to the ER yesterday. She is currently still sick.
woke up with rapid heart rate; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 29Apr2021 at 11:00 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety and post-traumatic stress disorder (PTSD). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food and other products. Concomitant medications included escitalopram oxalate (LEXAPRO) for unknown indication, from an unknown date. Prior to the vaccination, it was unknown whether the patient had received any other vaccines within four weeks. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 08Apr2021 at 11:00 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. On 30Apr2021 at 10:00 the patient woke up with rapid heart rate every morning and it picks up the patient at random times of the day, the patient also got a weird sensation at random times that her heart is beating harder than usual. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the adverse event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event woke up with rapid heart rate was not recovered at the time of this report.
PT REPORTED REDNESS AND SWELLING ON THE VACCINATION SITE ALONG WITH ITCHING
I experienced a blackout while eating at a restaurant and was not respondent to my wife, while my jaw/neck tightened up. EMT responded and was able to get my blood pressure back up from 111/72 on the low side of normal and said that orange juice that I took stabilized my glucose. They wanted me to go to the hospital, but I declined since I didn't pass out. I was advised that if the symptoms came back to go to the hospital, but blood pressure was taken, and it was a back to normal.
sick; fever; chills; hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "sick"; PYREXIA (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "fever"; CHILLS (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "chills"; URTICARIA (non-serious) with onset Feb2021, outcome "unknown", described as "hives".  Additional information: Patient stated that she had the first 2 vaccines, she came home she was sick, chills and fever to 24 hours and she got hives that was in February  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Before the vaccine my period was like clock work, very regular.. I am having a very unusual strong cramping since my covid vaccine that starts the day prior and my bleeding is lasting atleast 7 days, sometimes longer. I previously (prior to covid vaccine) only bled 3-5 days. I have also had recurrent yeast and bacterial infections that have been difficult to get rid of.
Mistakenly received the first dose of the vaccine; A spontaneous report was received from a nurse concerning a 17 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Product administered to patient of inappropriate age.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On Date 25-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) at unknown route and anatomical location for prophylaxis of COVID-19 infection.   The patient experienced the event medication error- 17 years old individual mistakenly received the first dose of the vaccine.   Treatment details if provided or No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the event 17 years old individuals mistakenly received the first dose of the vaccine unknown.; Reporter's Comments: This report refers to a case of inappropriate age at vaccine administration for mRNA-1273 (lot/batch: unknown)  with no associated AEs.; Sender's Comments:  MOD-2021-015769:Same reporter
Narrative: 82 yo male patient with CURRENT PROBLEM LIST: Peripheral vascular disease (SCT 4000470Hyperlipidemia (SCT 55822004) Hypercholesterolemia (ICD-9-CM 272.0) Other acquired deformities of ankle and foot (ICD-9-CM 736.79) Acute osteomyelitis involving ankle and Hemianopia (ICD-9-CM 799.9) Unspecified Sleep Apnea (ICD-9-CM 780.57Hearing loss (ICD-9-CM 389.9) Benign Localized Hyperplasia of ProstateFlatfoot (ICD-9-CM 734.) Complete Colonoscopy (ICD-9-CM 799.9) GERD (ICD-9-CM 530.81) Impotence, Organic Origin (ICD-9-CM 607.Hypertension (SCT 38341003) Arthritis, Rheumatoid (ICD-9-CM 714.0) Cerebrovascular Accident (ICD-9-CM 436.) AF - Paroxysmal atrial fibrillation (SCTOsteoarthrosis involving the knee (ICD-9-CM 715.98) died at home in home hospice care on 12/5/2021. Pt had received covid vaccines on 2/1/21 & 2/24/21 from outside hospital. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.