chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 2, single (Lot number: EN6204), in right arm and on 01Oct2021 as dose 3 (booster), single (Lot number: 301308A) at the age of 45 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset 13May2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical information: The patient had no known allergies and no other medical history. . No follow-up attempts are possible. No further information is expected.
Chills/Shivering same evening when I received the shingles vaccination. Lasted 1 day.
Low grade fever, nausea, stomach and abdominal pain/cramping, mid back pain, injection site pain/swelling, body aches, fatigue
A 25 year old male reported that he received his first dose of BioThrax in 2015 without any untoward effects. He states after receiving the 2nd dose, he experienced flu-like symptoms, nausea, and difficulty breathing. The consumer stated he has felt lethargic and tired in the last year; a blood test conducted within the last 30 days, revealed "low testosterone levels". He has scheduled an appointment to see an endocrinologist regarding the basis for his low testosterone levels. Additional information has been requested.
right sided numbness; severe headache; nausea; This is a spontaneous report from a contactable nurse, reporting for herself. A 22-year-old non-pregnant female patient received the first dose of the bnt162b2 (BNT162B2; Lot Number: EK4176), via an unspecified route of administration in the left arm on 15Jan2021 at 09:00 at a single dose for covid-19 immunization. The patient received the immunization in a hospital. Medical history included Ehlers-Danlos, allergic asthma, and fracture. Concomitant medication included drospirenone/ethinylestradiol (NIKKI) for birth control. There were no other vaccines given in four weeks. The patient previously took tramadol (MANUFACTURER UNKNOWN) and experienced allergies. On 28Jan2021 at 11:00, the patient experienced right sided numbness, severe headache, and nausea, which were serious for disability. Therapeutic measures were taken as a result of the events. The patient was treated in the emergency room and sent home with TIA protocol to follow with neurologist. There was no COVID prior or post vaccination. The clinical outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information currently available the causal association between the reported events right sided numbness, severe headache, and nausea and the usage of the vaccine BNT162B2 cannot be excluded but also the contributory role of the concomitant medications/medical history of the patient need to be taken into consideration. The case will be reassessed should the additional information be available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
After his 2 month shots, my son developed some shrill, high-pitched screaming and alternated between screaming and passing out for about 12 hours.  After the screaming/passing out episodes abated he slept really hard.  For the next two weeks he stopped making eye contact, smiling and cooing/babbling like he'd been doing.  We also observed him twitching/jerking his head in his sleep.  The twitching/jerking lasted for about two weeks as well.
pain at injection site,  moderate  joint and muscular pain starting about 8 hours later and later becoming severe for a total of about 11 hours. Mild joint pain continued for 2 more days. Currently have mild joint stiffness in fingers. Also mild fatigues and brain fog starting within a few hours and continuing until today. Had chills the first 2 days.
Left upper arm redness, swelling and pain . Noticed the redness spread to rest of the arm than at the injection site
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with the improperly stored dose of ZOSTAVAX (dose, route of administration, lot number and expiration date were not reported). Concomitant therapy was not reported. No adverse effect was reported. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown demographics. The patients medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored COMVAX (lot #, dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Post vax the patient developed a 1 1/2" round red splotchy area on his right arm in the deltoid area.
Information has been received from a medical assistant and a health care worker concerning an approximately 15 year old female patient who on 01-AUG-2007 was vaccinated with the first dose of GARDASIL (lot #656050/0245U). On 05-OCT-2007, was vaccinated with the second dose of GARDASIL (lot #657006/0188U), and on 13-AUG-2008, was vaccinated with the third dose GARDASIL (lot 659964/1978U), all doses intramuscularly into her left arm. About three weeks after receiving the third dose of GARDASIL, on approximately 03-SEP-2008, the patient experienced injection site inflammation with a lump at the site and swelling. There was no adverse symptoms from the first or second doses. On 10-SEP-2008, the patient was seen at the physician's office. At the time of the report, the patient had not recovered. Additional information has been requested.
ALTERED MENTAL STATE: MEMORY LOSS, CONFUSION DIANOSED AS TRANSIENT ISCHEMIC ATTACK SYMPTOMS RESOLVED WITHIN 24 HRS.
8/3/2021 Pt presents to ER. CT brain that shows no hemorrhage or CT evidence for acute large vessel infarction, marked ventriculomegaly out of proportion to the degree of sulcal atrophy.  Findings are concerning for normal pressure hydrocephalus. He was seen by the stroke neurologist, who recommends activated stroke protocol admission order set, stroke/telemetry floor, neuro checks, bedside swallow eval, DVT prophylaxis, IV fluids, normal saline, head of the bed 30 degrees, euglycemia, avoid hyperthermia. Cleared for dc 8/2 however prior to SNF placement, tested positive for COVID-19. Of note, patient received J&J COVID-19 vaccine March 2021.  8/11/2021: Pt discharged to SAR
Chronic obstructive pulmonary disease exacerbation; Hypertension; Reaction to COVID vaccine; Really sick; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Chronic obstructive pulmonary disease exacerbation), HYPERTENSION (Hypertension) and VACCINATION COMPLICATION (Reaction to COVID vaccine) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TREPROSTINIL SODIUM for Secondary pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension and Chronic obstructive pulmonary disease. Concomitant products included TADALAFIL for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and TREPROSTINIL SODIUM (Respiratory) at an unspecified dose four times per day. On an unknown date, TREPROSTINIL SODIUM (Respiratory) dosage was changed to 72 mcg and TREPROSTINIL SODIUM (Respiratory) dosage was changed to 60 mcg. On 25-Mar-2021, the patient experienced CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Chronic obstructive pulmonary disease exacerbation) (seriousness criterion hospitalization), HYPERTENSION (Hypertension) (seriousness criterion hospitalization) and VACCINATION COMPLICATION (Reaction to COVID vaccine) (seriousness criterion hospitalization). On an unknown date, the patient experienced ILLNESS (Really sick), NAUSEA (Nausea) and HEADACHE (Headache). The patient was hospitalized from 25-Mar-2021 to 28-Mar-2021 due to CHRONIC OBSTRUCTIVE PULMONARY DISEASE, HYPERTENSION and VACCINATION COMPLICATION. At the time of the report, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Chronic obstructive pulmonary disease exacerbation), HYPERTENSION (Hypertension), VACCINATION COMPLICATION (Reaction to COVID vaccine), ILLNESS (Really sick), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Description: On an unreported date, the patient had decreased treprostinil sodium breaths from 12 to 10 breaths (off label use).  Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.
sore arm; Headache; coldness in the extremities; dizziness; fatigue; Nausea; itchiness arm; red arm; diarrhea; stomach cramps; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), DIZZINESS (dizziness), FATIGUE (fatigue), NAUSEA (Nausea) and PRURITUS (itchiness arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylaxis (Improved May 2015 when stopped Pantaprazole) since 03-Jan-2013. Concurrent medical conditions included Drug allergy (Pantoprazole (oral) and possibly others in PPI class), Hypothyroidism since 09-Jan-1990 and Migraine since 07-Jan-1968. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) from 15-Mar-2013 to an unknown date and MONTELUKAST from 15-Mar-2013 to an unknown date for Anaphylaxis, BISACODYL (EQUATE GENTLE LAXATIVE) from 01-Apr-2007 to an unknown date for Constipation, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) from 01-Sep-1991 to an unknown date for Hypothyroidism.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps). On 15-Mar-2021, the patient experienced DIZZINESS (dizziness), FATIGUE (fatigue), NAUSEA (Nausea), PRURITUS (itchiness arm), ERYTHEMA (red arm), DIARRHOEA (diarrhea) and FEELING COLD (coldness in the extremities). On 16-Mar-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). On 18-Mar-2021, DIZZINESS (dizziness), FATIGUE (fatigue), NAUSEA (Nausea), PRURITUS (itchiness arm), ERYTHEMA (red arm), DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach cramps) and FEELING COLD (coldness in the extremities) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) and HEADACHE (Headache) had resolved.            Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-133079 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: Patient information added, medical history and medication history added. Outcome of the events added.
Severe suicidal ideation, ever since vaccination was administered.  This has continued to worsen.  Before being vaccinated, mental health was at the best it had been in years.
This spontaneous report as received from a physician refers to an approximately 12 years old female patient. The concurrent condition and medical history were none. On 03-MAR-2016 the patient saw the primary care physician who vaccinated the patient with GARDASIL 9 dose 1 (route, dose and lot details unavailable). The concomitant medications were none. On 08-MAR-2016, the patient was seen in the urgent care with abdominal complaints, itchiness, lip swelling and hives located over the trunk, arms, legs, back, abdomen and chest developed on an unspecified date in March 2016. No lab tests were done. The patient was treated with BENADRYL, prednisone (manufacturer unknown) and loratadine (manufacturer unknown). It was reported that the hives lingered intermittently for 3 days. The outcome of hives was reported as resolved on an unknown date in March 2016 and the outcome of all other events were unknown. The causality was unspecified. Additional information has been requested.
Altered mental status; This is a spontaneous report from a contactable pharmacist. A 74-year-old male patient received bnt162b2 (BNT162B2 Formulation; solution for injection), dose 1 intramuscularly, administered in Arm Left on 25Feb2021 (Batch/Lot Number: EN6203) as DOSE 1, SINGLE (at the age of 74-year-old) for covid-19 immunisation. Medical history included hypertension, hyperlipidemia, diabetes and Known allergies Adhesive tape: silicones from an unknown date and unknown if ongoing. The patient did not have COVID prior vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if other medications in two weeks received or not. The patient experienced altered mental status on 25Feb2021. The patient not tested for COVID post vaccination. It was unknown if any treatment received for event or not. The outcome of event was unknown.  Follow-up attempts completed. No further information expected.
Felt like had the flu; Lethargic; Hurt terribly for two days / Achy; This case was reported by a consumer and described the occurrence of pain in a 84-year-old 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 2 years after receiving Shingrix, the patient experienced pain, influenza-like symptoms and lethargy. On an unknown date, the outcome of the pain was recovered/resolved and the outcome of the influenza-like symptoms and lethargy were unknown.   It was unknown if the reporter considered the pain, influenza-like symptoms and lethargy to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient hurt terribly for two days and also felt like had the flu, felt achy and lethargic. The patient would be receiving 2nd dose of Shingrix the day after reporting date and asked whether there something the patient could do to prevent this.
Approx. one hour after receiving HEPATITIS B vaccine injection site became matted looking and child's hands got cold.  Injection site became red and swollen about 2 ½ cm- induration.  Patient was taken to emergency room where she received Benodryl and Decadron and was released.
A non-serious spontaneous report of "29 patients ( 26 children & 3 adults) received expired FLUMIST "was received from a physician concerning a 19-year-old female. The patient's medical history included no history of asthma. Concomitant medications were not available. On 06-Jan-2009, twenty nine patients were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications). There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved. On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customer not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 05-Feb-2009 and incorporated into the narrative: gender and age; confirmation that there were no adverse events. Additional information received on 04/09/2009 included Product Complaint Investigative results.
5/23/21 ER to Admission, HPI:  Patient is a 79 y.o. female admitted to acute care from ED per Dr. with septicemia, acute UTI, pneumonia of right upper lobe..  The patient presented to ED brought in by EMS from local residence complaining of altered mental status.  Patient states she woke up yesterday morning chilling.  States she just could not get warm.  Went back to bed for I while.  States she did get up and go to church.  After eating dinner had went over to her grandson's.  She became confused at that point.  Has been states that speech was difficult to follow.  Did become slightly slurred.  EMS was called and patient was brought to ER for further evaluation.  Upon arrival to ER patient's temp is 102.4°.  CT scan head negative for acute changes.  Chest x-ray did show right upper lobe changes questionable infiltrate.  Lactic acid 1.1 procalcitonin negative.  Urine was highly positive with GNR on gram stain.  Patient given L of normal saline along with Zosyn in ER.  Subsequently admitted to acute care for further evaluation and treatment including IV antibiotics and further monitoring.  Foley catheter placed ER.
Patient given INFLUENZA vaccine on 10/15. Patient reported on 10/16 she developed swelling, erythema tenderness, and site was warm to the touch. Patient sent to clinic for eval, was referred to workers comp. Dx'ed allergic reaction to vaccine.
Pain/ all over pain; Sweating; Cold sweats; Felt like I was hit by a train; Around chest areataking a deep breath in  - hurt(around ribs); Red splotchy parts/ all the way down to elbow/ now swollen red and warm; Warm near injection site; It's now swollen; Fever/101 temperature; Achiness/muscle aches; Red near injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain/ all over pain), HYPERHIDROSIS (Sweating), COLD SWEAT (Cold sweats), FEELING ABNORMAL (Felt like I was hit by a train) and MUSCULOSKELETAL CHEST PAIN (Around chest areataking a deep breath in  - hurt(around ribs)) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included IBUPROFEN for Headache, BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Pain/ all over pain), HYPERHIDROSIS (Sweating), COLD SWEAT (Cold sweats), FEELING ABNORMAL (Felt like I was hit by a train), MUSCULOSKELETAL CHEST PAIN (Around chest areataking a deep breath in  - hurt(around ribs)), RASH MACULAR (Red splotchy parts/ all the way down to elbow/ now swollen red and warm), VACCINATION SITE WARMTH (Warm near injection site), SWELLING (It's now swollen), PYREXIA (Fever/101 temperature), MYALGIA (Achiness/muscle aches) and VACCINATION SITE ERYTHEMA (Red near injection site). At the time of the report, PAIN (Pain/ all over pain), HYPERHIDROSIS (Sweating), COLD SWEAT (Cold sweats), FEELING ABNORMAL (Felt like I was hit by a train), MUSCULOSKELETAL CHEST PAIN (Around chest areataking a deep breath in  - hurt(around ribs)), RASH MACULAR (Red splotchy parts/ all the way down to elbow/ now swollen red and warm), VACCINATION SITE WARMTH (Warm near injection site), SWELLING (It's now swollen), PYREXIA (Fever/101 temperature), MYALGIA (Achiness/muscle aches) and VACCINATION SITE ERYTHEMA (Red near injection site) outcome was unknown.            Concomitant medication also included muscle relaxant at night.  No treatment information was provided.
Received expired second dose; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A and 037f21a) for COVID-19 vaccination.     No Medical History information was reported.   On 09-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 03-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was mentioned. No treatment medication was mentioned.   This case was linked to MOD-2021-347607 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Follow up received contains non significant information (reporter information) but in initial version missed to captured dose 1 details and event inappropriate scheduled of vaccine administered hence updated in FU.
After first injection - sore upper arm - resolved in one day After second injection - severe body aches, headache, 100.5 fever, nausea, mild vomiting, mild diarrhea lasting for 36 hours.  Stomach upset continuing 3 days later without resolve yet.
Site - red, hot swollen at site of Varicella vaccine - 2" x 3", painful, swollen hot; c/o joint pain. Tx with KEFLEX/Steroid --> took 4 D to resolve.
This spontaneous report as received from a nurse refers to unspecified patients. On an unknown date of 2014 (also reported  as since 29-SEP-2014), the patients was vaccinated with RECOMBIVAX HB which was improperly stored, injection 10/1.0 microgram/ml, (strength, dose and route unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
My left upper arm became increasingly more painful and red over 2-3 days with a low grade temp, anorexia. The erythema was primarily in the anterior area of upper left arm and not at the injection site.