chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Contracting COVID confirmed by multiple at home tests; Contracting COVID confirmed by multiple at home tests; dose 4 (booster); dose 4 (booster); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 21Apr2022 as dose 4 (booster), single (Lot number: AI8028) at the age of 51 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DILTIAZEM; HYDROCHLOROTHIAZIDE; PAXIL [PAROXETINE HYDROCHLORIDE].  The following information was reported: OFF LABEL USE (medically significant), IMMUNISATION (medically significant) all with onset 21Apr2022, outcome "unknown" and all described as "dose 4 (booster)"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 23May2022, outcome "recovered" and all described as "Contracting COVID confirmed by multiple at home tests". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23May2022) Positive, notes: Contracting COVID confirmed by multiple at home tests; (30May2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19, drug ineffective.  Follow up information has been requested.
sore arm; swollen arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm and swelling arm. On an unknown date, the outcome of the pain in arm and swelling arm were recovered/resolved.   It was unknown if the reporter considered the pain in arm and swelling arm to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's father The age at vaccination was not reported. Reporter stated that patient experienced sore arm and swollen arm after dose of Shingrix which she received a year ago. Symptoms lasted for a few days. It was unknown if she received second dose. The reporter did not consent to follow-up. This case had been linked with cases US2022001255 and US2022001252, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022001255:Same reporter US-GLAXOSMITHKLINE-US2022001252:Same reporter
second dose soreness in left arm, Nightime pain in right arm; cold not full chills but cold; shoulder neck down to wrist very sharp pains like muscle cramps; shoulder neck down to wrist very sharp pains like muscle cramps; shoulder neck down to wrist very sharp pains like muscle cramps; This is a spontaneous report from a contactable 72-year-old female consumer reported for herself that she received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3247) single dose on 16Feb2021 09:00 AM at left arm for COVID-19 immunization. Medical history was not provided. Historical vaccine included 1st dose of BNT162B2 (EL3247) on 25Jan2021 at 11:30 AM at left arm for COVID-19 immunization. Concomitant drugs included lisinopril, levothyroxine sodium (LEVOTHYROXIN), pravastatin, vitamin D and vitamin K. The patient reported second dose soreness in left arm, cold not full chills but cold, Nightime pain in right arm, shoulder neck down to wrist very sharp pains like muscle cramps started on 17Feb2021 at 01:00 AM. No treatment was received for the events. Event outcome was recovered.
$ days later , had very severe  stiffness and pain , in muscles , and shoulders , hands were swelled up , unable to make a fist for several , hours in morning , had to use a cane , and unable to move shoulders , and also felt very tired
It doesn't gave any bad of side effects as moderna does; This spontaneous case was reported by a non-health professional and describes the occurrence of IMMUNISATION REACTION (It doesn't gave any bad of side effects as moderna does) in a 32-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (It doesn't gave any bad of side effects as moderna does). At the time of the report, IMMUNISATION REACTION (It doesn't gave any bad of side effects as moderna does) outcome was unknown.            No concomitant medication information was provided.  The patient reported that she got less side effects with Pfizer when compared with Moderna and that made Pfizer vaccine unique and different from other covid-19 vaccines.  No treatment medication were provided.
my heart rate starting climbing and fast; My blood pressure, when first taken was very high; chest discomfort; whole body aches; general feeling of being exhausted and weak; general feeling of being exhausted and weak; respiratory rate climbed; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 36-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FA6780 and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 26Jul2021 at 19:30 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced my heart rate starting climbing and fast, my blood pressure, when first taken was very high, chest discomfort, whole body aches, general feeling of being exhausted and weak and respiratory rate climbed on 27Jul2021 at 13:30 (After almost 24hrs from the first shot). The event resulted in Emergency room/department or urgent care. The patient received treatment for the adverse events as Ativan, nitrostat and Zofran with IV. Outcome of the events was recovered on an unknown date in 2021.
Participant complains of "slight pain at injection site" 1 week post vaccination "which progressed to debilitating pain in the left arm.  Extreme tenderness at injection site and extreme pain upon movement of arm" 10 days post vaccination.
Information has been received from a health professional concerning a 2 month old male who on 14-AUG-2007 was vaccinated with a first or second dose of Rotateq (Lot# "0962U"). On 17-AUG-2007 a change in stool and blood was reported, and on 04-SEP-2007 definite hematochezia was reported. Upon internal review, the patient's hematochezia was considered to be an other important medical event. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a nurse via a company representative and refers to a patient of unknown demographics. No information regarding the patient's medical history, concomitant medications, concurrent conditions and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, lot number and expiration date were not reported). Other suspect therapies included sterile diluent (dose, lot number an expiration date were not reported). On an unknown date, after receiving ZOSTAVAX the patient died. The cause of death was not reported. It was unknown, whether the autopsy had been performed. The relatedness between the event and ZOSTAVAX was not reported. Upon internal review, the event of death was considered to be medically significant. Additional information is not expected as there was no consent for further contact with the reporter.
No additional AE.; the third dose was received at the office but was not documented in the system so a fourth dose was administered to the patient at a pharmacy.; This spontaneous report was received from a advanced practice registered nurse (A.P.R.N.) and refers to a 23 year old male patient. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  The patient was already on the three dose series (not specific information provided). It was reported that the third dose was received at the office but was not documented in the vaccination system so, on 26-FEB-2023, a fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis was administered to the patient at a pharmacy (route of administration, frequency, lot/batch # and expiration date were not reported) (extra dose administered). The reporter did not have lot/expiration as the dose was not given at his facility. No additional event was reported.   No further clarify.
Fever, maculopapular rash face, arms/ legs, chest, ------. 103 degrees F.
fever, irritability, crying, T101.3, HR-180,  onset w/in 4hr;treated w/APAP alternated w/childrens motrin & referred to PCP;
This spontaneous report as received from a health care worker refers to unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with PROQUAD (Merck) vaccine, 0.5 ml, subcutaneously (strength, lot number and expiry date were not reported), which were improperly stored. No concomitant medication was reported. The PROQUAD (Merck) vaccines were exposed to a maximum of 9.9 degree F for a total of 188.5 hours, on multiple occasions. No adverse effects were reported. The outcomes of the events were unknown. A product quality complaint (PQC) was not involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
1506: 23 year old female feeling congestion and itching to arms and throat. Physician on duty assessing patient and gave Benadryl 50mg PO total to patient. Patient able to drink water without difficulty.  Patient discharged home after 60 minutes of observation.
Having muscle spasms in both arms throughout the day. It is causing a lot of pain in her arms that makes it impossible to lift.
THE ARM THE CHILD RECEIVED FLU SHOT IN WAS SWOLLEN THE SIZE OF A GRAPEFRUIT,WARM AND ITCHED.
patient reported itching all over body after dose today when she got her booster. It resolved after a day.
Rash appeared after showering at 10 am 3/06/2011.  Rash on both elbows and knees.  Mother states it looks like "several circles on both elbows, both knees, darker rim, white on inside of circle".  Child denies itching or discomfort.  PMD states he feels is delayed reaction from immunizations given on 3/3/2011.  Benadryl was recommended by PMD. Mother states Bedadryl was effective and rash "is going away".
Member c/o generalized itching 30 min post Pfizer vaccine. Member with hx of allergic reaction to abx. Reports typical reaction is hives and/or itching. Denies difficulty breathing, no hives present. 25 mg PO Benadryl given per Dr. Pt instructed to remain in observation for additional 30 minutes. Pt declined further observation. Per Dr, pt educated to monitor reaction, if progresses to hives will need allergy eval prior to receiving 2nd dose. Pt discharged with companion. Dr to f/u with phone appt for eval.
Pneumonia or Pneumonitis Weakness Severe hypoxia Cough Atrial fibrillation Dyspnea Death  Progressed from ambulatory to death in 8 days
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 27-AUG-2014 the patient received a dose od M-M-R II (dose, route not reported, lot # J009706, expiration date 15-AUG-2015) exposed to temperatures outside of the proper storage range. Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a female who was vaccinated with her first dose of Gardasil and began menstruating. Subsequently the patient experienced heavy menstruation. The patient sought unspecified medical treatment at the clinic. Lot number was not available. Additional information has been requested.
MA gave the wrong vaccine to a 16 mo. old during a Well Child Check Clinic on 8/18. The patient was to be given a DTAP but was given a TDAP.
About a month ago, my arm started to feel sore, like I had received the shot a few days ago, not months ago. The muscle soreness is increasingly painful. I had a physical two weeks ago, and I received a shoulder x-ray ending up in a ?mild arthritis? diagnosis for my shoulder. However, the pain is in the muscles surrounding my vaccine injection and is the same type of soreness. I got ?Moderna arm? two weeks after my first Moderna vaccine and had symptoms of fever, body aches, and soreness, exhaustion and nausea from Friday afternoon a few hours after the second vaccine until 1 pm the following Tuesday.
METALLIC TASTE; SORE ARM; PAIN IN SHOULDER; HEADACHE; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included breathing issues, milk allergy, sulfa drug allergy, and hoarseness of voice, and other pre-existing medical conditions included the patient is not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Non-company suspect drugs included: clarithromycin ( batch number: UNKNOWN expiry: UNKNOWN, form of admin, route of admin, and were not reported) 500 mg, 2 times every 1 day, therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On 09-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced metallic taste. On 11-APR-2021, the subject experienced sore arm. On 11-APR-2021, the subject experienced pain in shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from metallic taste, sore arm, headache, and pain in shoulder. This report was non-serious.
Patient received vaccine, on COUMADIN and days after arm sore to move and hematoma under skin. Pt went to Dr. Pt INR increased. Arm improving per patient.
I had severe fever, nausea, loose stool, then developed a lump (the size of a golf ball) on my left armpit. It hasn't been treated yet, I called the pharmacy where the shot was administered, and I was advised to put ice on it, that it may take sever days, weeks, or month to subside.
none reported Narrative:  An 83yo male with history of Parkinson's Disease, Anemia, Prostate cancer, History of Malignant Melanoma and Neoplasm of Intraabdominal Lymph node, who is on full care by Hospice. Received Covid- 19 vaccine on February 2, 2021 at 13:00 and Nurse's documentation stated it was administered without any complications per policy and Protocol Oncology documentation of February 2, and 3, 2021 indicated he had stage IV Metastatic Melanoma and Prostate Cancer with poor prognosis. He received chemotherapy on February 3, 2021 and left the clinic in stable condition accompanied by his wife. On February 5, 2021 patient called regarding concerns of father's condition with increased urination and pain. The patient also expressed experiencing increased bowel movement which was discussed with his Palliative care provider. Patient called back on February 8, 2021 with concerns of Chest pain and musculoskeletal pain and presented to the ED on February 9, 2021 with complains of Chest pain. In the ER Post EKG of known RBB and negative troponin, CBC/CMP at prior baseline without gross abnormality, -ve Covid, -ve PE and known RT Pleural Effusion and having well controlled pain, he was discharged home with daughter with continued Oncology, palliative and PCP follow up. Documentation has it that his case was discussed with Oncology and Palliative care The patient passed away on February 11, 2021
almost like she is having symptoms of meningitis; 101.5 temp; pain; was up in pain all night; This case was reported by a other health professional via sales rep and described the occurrence of possible meningitis in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero with an associated reaction of headache (1st dose, for tolerance refer case US2020AMR201419).   In October 2020, the patient received the 2nd dose of Bexsero. In October 2020, 1 day after receiving Bexsero, the patient experienced meningitis (serious criteria GSK medically significant), fever, pain and insomnia. Rechallenge with Bexsero was positive. On an unknown date, the outcome of the meningitis, fever, pain and insomnia were unknown.   It was unknown if the reporter considered the meningitis, fever, pain and insomnia to be related to Bexsero.  Additional details provided as follows: The age at vaccination was not reported, however the patient could be of 17 to 18 years old at a time of vaccination. The patient received her 2nd Bexsero, a day prior to this report and next day she woke up with 101.5 temperature and was up in pain all night last night. It was almost like she was having symptoms of meningitis. The reporter consented for follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR201419:1st dose
This spontaneous report as received from an unspecified reporter via another company refers to several female patients of unknown ages. On 02-DEC-2014 these patients were vaccinated with RECOMBIVAX HB (strength, dose, route and expiration date not reported, lot# reported as K012933). The reporter reported this product had been exposed to temperatures outside of the required temperature range and the efficacy of this product outside the temperature range had not been established. This is one of several reports received from the same reporter. Additional information has been requested.
Dizzy; Fell; Felt weakness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt weakness), DIZZINESS (Dizzy) and FALL (Fell) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced ASTHENIA (Felt weakness) and FALL (Fell). On 10-Mar-2021, the patient experienced DIZZINESS (Dizzy). At the time of the report, ASTHENIA (Felt weakness), DIZZINESS (Dizzy) and FALL (Fell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  No treatment information was specified.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Pt has a PMH significant for dementia, anxiety. Per note "Resident since 2013 with progressive dementia. He has h/o PTSD, depression and anxiety disorder along with progressive dementia (possibly fronto-temporal) with associated behavioral disorder. He has been non-ambulatory , dependent on all ADL's and not recognizing family for >2yrs per wife."
I became very fatigued , no energy  for daily tasks. I developed a non productive cough, moderate headache, and  low grade fever.  now my nose is  congested. I feel alittle stronger 18 hrs. later. But I called in sick  tonight to work nights as a night RN, on a COVID unit. I have been working with COVID  Patients  after getting  the first of two  Moderna  vaccines.
Information has been received from a physician concerning a 4 month old patient who was vaccinated PO with a first dose of Rotateq. No further information was provided.  There was no product quality complaint. Additional information has been requested.
Ear pain in right ear; Cold sores on right side of mouth; Throat was hurting; Sinus pressure under right eye; Cough; Aches; Fatigue; Fevers ranging from 98.5-102.5F; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (Ear pain in right ear), ORAL HERPES (Cold sores on right side of mouth), OROPHARYNGEAL PAIN (Throat was hurting), PARANASAL SINUS DISCOMFORT (Sinus pressure under right eye) and COUGH (Cough) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EAR PAIN (Ear pain in right ear), ORAL HERPES (Cold sores on right side of mouth), OROPHARYNGEAL PAIN (Throat was hurting), PARANASAL SINUS DISCOMFORT (Sinus pressure under right eye), COUGH (Cough), PAIN (Aches), FATIGUE (Fatigue) and PYREXIA (Fevers ranging from 98.5-102.5F). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, EAR PAIN (Ear pain in right ear), ORAL HERPES (Cold sores on right side of mouth), OROPHARYNGEAL PAIN (Throat was hurting), PARANASAL SINUS DISCOMFORT (Sinus pressure under right eye), COUGH (Cough), PAIN (Aches), FATIGUE (Fatigue) and PYREXIA (Fevers ranging from 98.5-102.5F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Feb-2021, SARS-CoV-2 test: positive (Positive) reports testing positive for COVID-19 on 7Feb2021. In 2021, Pyrexia: 98.5-102.5f (abnormal) Fevers ranging from 98.5-102.5F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. In addition to paracetamol, patient reported taking fluids for treatment.
Cough, SOB, Nausea, Vomiting, Fatigue.  Treatment was REMDESIVIR, SOLUMEDROL.
Student immunized today x1 left deltoid with 25 gage 1 inch needle.  Reports no c/o, no breakfast.  Student passed out after a few minutes, passed and slumped forward, biting her lower lip with out of line tooth on the bottom row, inside and outside of mouth, cool compresses and ice applied with good results.  v/s 118/76, temp 97.6 resp 16, pulse 72.
Pain at injection site,  difficulty sleeping, fatigue whole next day.  bed rest,  fatigue gone by 6pm day after,  arm sore for 3 days