chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Around 6:30pm baby started crying uncontrollably. I breastfeed and he wouldn't take the breast. He was screaming loud and squeaking  and was non stop crying for an hour. I had already given him motrin because he was very uncomfortable from the beginning, i also gave him a warm bath to see if that would calm him down it did for about 5 minutes then the screaming started again. His entire leg swelled up thats  why i gave him a warm bath.  i called the doctors office the answering service and told me to give him benadryl.   Our son is irritable everyday since the vaccine. Hes usually happy and playful he playful but get easily irradiated, which is not his normal. Im praying he goes back to being the sweet calm baby we had.
Patient initially seen in facility with COVID symptoms and testing which was positive around 9/1/21.  Pt presented at ED on 9/14 and 9/27 for continued symptoms and treatments.  Was not hospitalized either visit.
This spontaneous report as received from a pharmacist refers to a 9 month old patient. On an unknown date the patient was vaccinated with (Oka/Merck) PROQUAD. The pharmacist reported that the 9 month old patient was administered a dose of (Oka/Merck) PROQUAD which was before the 12 month old age recommendation. No adverse effects reported. Additional information has been requested.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 18-NOV-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L020189, expiration date: 03-JUN-2017) (incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Swelling, redness & warmth to touch on right arm. Mild pain, no SOB.
Patient hospitalized for "PROM. She was induced with cytotec followed by pitoicn. She pushed for 4 hours then had a primary CS for failure to progress. Postpartum course complicated by elevated BP. Labs ordered, but she did not meet criteria for preeclampsia. Discharged home on POD 3. BP check in 2 days."
VOMITING, REDNESS ON R THIGH WHERE VACCINE WAS ADMINISTERED.
stiffness; Patient had osteoarthritis but it seems to explain exacerbated; overall joint and muscle pain; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness), OSTEOARTHRITIS (Patient had osteoarthritis but it seems to explain exacerbated), ARTHRALGIA (overall joint and muscle pain) and MYALGIA (muscle pain) 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 24-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness), OSTEOARTHRITIS (Patient had osteoarthritis but it seems to explain exacerbated), ARTHRALGIA (overall joint and muscle pain) and MYALGIA (muscle pain). At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness), OSTEOARTHRITIS (Patient had osteoarthritis but it seems to explain exacerbated), ARTHRALGIA (overall joint and muscle pain) and MYALGIA (muscle pain) outcome was unknown.            Concomitant product was not provided by the reporter. Treatment information was not provided.
Headache; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 007B21A and 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Ligament tear and Gout (bone on bone). Concomitant products included MELOXICAM for Knee ligament injury.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On 24-Nov-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) had not resolved and PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient is having a torn ligament on his knees and waiting for MRI for his knee. Patient received a steroid shot for the knee in the past but that only worked for about 24 hours.  No treatment details were provided.   This case was linked to MOD-2021-395997 (Patient Link).
When she stands up it still hurts; large broken vessel about the size of a nickle; leg was itching; This spontaneous case was reported by an other (subsequently medically confirmed) and describes the occurrence of VASCULAR RUPTURE (large broken vessel about the size of a Nickle) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure, Thyroid disorder NOS and Cholesterol.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced PRURITUS (leg was itching). On 08-Apr-2021, the patient experienced VASCULAR RUPTURE (large broken vessel about the size of a Nickle) (seriousness criterion medically significant). On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (When she stands up it still hurts). At the time of the report, VASCULAR RUPTURE (large broken vessel about the size of a Nickle) and PRURITUS (leg was itching) outcome was unknown and PAIN IN EXTREMITY (When she stands up it still hurts) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Ultrasound scan: abnormal abnormal (abnormal) a large broken vessel about the size of a Nickle.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included acetaminophen.  Company Comment: 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.
I received inj 2009 H1N1 influenza vaccine on 10/23/09 and on 11/2/09 at 1600. Started getting neuropathic pain in my R brachial plexus radiating to R side head & down arm.
AT 2:00 A.M.HAD THE SWEATS BURNING UP NEEDED TO TAKE SHOWER TO COOL DOWN THAN HAD CHILLS AND BODY ACHES, AND HEADACHE STARTED, HAD A HARD TIME FUNCTIONING. THIS WENT ON FOR TWO DAYS THEN HEADACHE FOR A WEEK AND LEGS WERE PAINFUL TO WALK STILL ARE HEADACHE GONE BUT PAIN IN LEGS, STILL TAKING ADVIL ITS BEEN TWO WEEKS SINCE THE SHOT.
Swelling in left arm, bruising, and blisters. Gave Benadryl
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot#, dose and route were unknown). On an unknown date the patient experienced injections site reaction after receiving the dose of GARDASIL. The outcome of event was unknown. This is one of two reports received from the same reporter. Additional information has been requested.
gave expired vaccine to patient; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave expired vaccine to patient) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot# 02B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave expired vaccine to patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave expired vaccine to patient) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication details provided. No treatment information provided.
An 83-year-old female with history of moderate dementia, frailty, gait impairment, hypertension, hyperlipidemia, asthma/OSA presented with cough and fever. Found to be COVID-19 positive. She received the COVID-19 vaccine in the spring. She initially required 2L o2, but weaned off quickly and has been stable for >24 hrs. Now medically ready for discharge.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns an 87 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 13-Sep-2016, the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Not reported. Batch number: WT53706. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 13-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. The patients will be contacted for revaccination.
Began having tightness in the throat and difficulty getting a deep breath within 14 minutes of receiving the vaccine.  Voice became hoarse.  Later lips began to swell.  IM Benadryl and epinephrine were given.  Then she was taken to the Emergency Room.  Symptoms continued and she was given Solumedrol.
SUDDEN CARDIAC DEATH CAUSED BY MYOCARDITIS; This spontaneous report received via social media from a patient via a company representative concerned a 30 year old male. The patient's weight, height and medical history were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: not reported) 1 total dose administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, after eight days of vaccination, the patient died of sudden cardiac death caused by myocarditis. The reporter figured all this in the news and thought it could be related. The cause of death was myocarditis. It was unknown whether an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210632922-covid-19 vaccine ad26.cov2.s-sudden cardiac death caused by myocarditis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: MYOCARDITIS
Pfizer BioNTech Vaccine administered(patient also took paxlovid for covid-19 treatment after received BNT162b2); Pfizer BioNTech Vaccine administered(patient also took paxlovid for covid-19 treatment after received BNT162b2); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EL 9266), on 18Mar2021 as dose 2, single (Lot number: ER 2613), in left arm and on 26Sep2021 as dose 3 (booster), single (Lot number: FF 2589) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "ragweed allergy" (unspecified if ongoing); "Cats" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL, start date: 25Apr2022, stop date: 06May2022. Past drug history included: Naltrexone, reaction(s): "allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Apr2022, outcome "not recovered" and all described as "PAXAES report with Pfizer BioNTech Vaccine administered(patient also took paxlovid for covid-19 treatment after received BNT162b2)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) Positive; (29Apr2022) Positive, notes: still tested positive but very faint antigen test line. Therapeutic measures were not taken as a result of vaccination failure. Therapeutic measures were taken as a result of covid-19.  Additional information: Patient received other medication in 2 weeks. PCR results came back positive on 26Apr2022 & started Paxlovid that same day. Symptoms decreased over time and still tested positive but very faint antigen test line on Friday 29Apr and symptoms pretty much gone. Ended Paxlovid on Saturday 30Apr. Sniffles, sore throat, and slight cough developed again Monday evening 05Feb22 and have been worsening since then.
About 10-12 hours after receiving the vaccine, patient had a significant increase in seizures - had seizure clusters (never had them previously). Patient had to be admitted to the hospital. Received rescue anti-seizure medication en-route via EMS, then additional Levetiracetam Bolus after arriving to the ER and subsequently additional dose of IV lacosamide following admission. seizures returned to baseline frequency about 3 days later.
Breakthrough Case Patient received Moderna Vaccine on 03/03/2021 and 03/31/2021. Also received Moderna Booster on 09/27/2021. Lot # 040B21A.
It is explained that with the first 2 shots she noticed she was tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 13Feb2021 (Batch/Lot number: unknown) as dose 2, single and (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: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "It is explained that with the first 2 shots she noticed she was tired".  Additional information: Caller reporting on the Pfizer Booster shot for Covid 19 and who explains she had it at the 6 month mark, around there. It is explained that with the first 2 shots she noticed she was tired but with the booster shot, after 4 days, her blood pressure went down to 109/69, 116/63, and 109/66. She is wondering if this is a side effect as it was not listed in the literature she was given.  Follow-up (05Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
"My" cheeks are red, 24 hours after "I" received the vaccine; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729 or EB8729) via an unspecified route of administration in the left arm on 26Apr2021 at 13:15 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis, hashimoto's and rosacea. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. Concomitant medications included methotrexate (MANUFACTURER UNKNOWN) for unknown indication from unknown date and unknown if ongoing. On 27Apr2021 at 16:00 the patient's cheeks were red, 24 hours after receiving the vaccine. The events did not result in doctor or other health care 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 event cheeks was red was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
patient was administered the vaccine on 10/17/2021 with a lot that expired 10/13/2021. no adverse event reported at this time
None on the first dose. But second dose: Wednesday afternoon and Thursday I was exhausted, had chills, body aches and slight headache. All went away by Friday but on Saturday at around 6 PM I broke out in itchy hives all over my body. It's now Sunday around 3:30 and I still have them. If they persist tomorrow, I might go to urgent care. Currently taking Benadryl but not helping very much at all except to make me sleep.
Patient c/o large red spot and lump under the skin, warm to touch at the injection site. Initially, the large red spot appeared 1 day after vaccine, went away, and reappeared. On March 26, pt. took Claritin, one tablet. On March 28th and 29th, pt. took 2 Claritin tablets. Pt. stated the lump went away and warmth left too.
Itching rash and indurated; 2x3cm on left arm. Also fever.
patient fainted after 10 minutes of receiving the Pfizer vaccine. He revived really quickly. Did not require paramedic help. Patient was confused for a very short period. Bumped his right knee but no head injury.
macular papular lesions, approx seven of different stages, occuring three weeks after vaccination, called cdc
flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced INFLUENZA (flu). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Flu, at a dose of 1 dosage form. At the time of the report, INFLUENZA (flu) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Small area of erythema under the bandaid found by the patient 13 hours after administration.  Within the next 24 hours, erythema had spread to area (3 in x 5 in) across the arm, was hot to touch and swollen.  Patient sought medical care at an urgent care center.  Celullitis was diagnosed.  Keflex 500mg capsules prescribed (1 cap QID) for 7 days along with probiotics.
Narrative:  PATIENT PASSED AWAY DUE TO COVID-19 . HE WAS IN THE HOSPITIZED AND HAD RECEIVED A COVID-19 VACCINE.
I?ve become extremely sensitive to the smell of methane, and my sense of taste has shifted.
I received an influenza vaccine around 11:30AM. At approximaly 1:30AM that night I woke up with severe chills and body and joint aches. After about 30 minutes of shivering in bed, I fell back asleep and woke approximately and hour later sweating heavily and still had joint and body aches. I also had a headache at this time. I was in and out of sleep for the next 3 hours (approximately) as these symptoms continued. Upon waking for the day, I felt fatigued (could also be due to poor sleep), and the headache remained for approximately 24-hours.
Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A, 027A20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.  The patient received an expired dose of the Moderna COVID-19 Vaccine as a booster dose. The vaccine was initially stored in 22-Oct-2021 and expired on 24-Oct-2021 and was administered to the patient on 25-Oct-2021.   This case was linked to US-MODERNATX, INC.-MOD-2021-363183 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-363183:Cross linked case/ Master case
Five hours after the vaccine I started to have some symptoms. Within 12 hours I had a fever of 106.5. I consulted with a doctor by which I was advised to take Motrin and the fever did not reduce. I took a double dose of Motrin and it did help take down the fever. The next time I took a regular dose of Motrin my fever reduced to 94 degrees. I was advised to keep warm. At the end of the third day my fever was still a little low. I was unable to function at all for three days. I also had a headache, chills and really bad body aches. I felt like I could not think or move during the three days after the second dose. My parents were calling the doctor during that time. I have never had a history of high fevers. I had a headache that continued for about two weeks after that time. It was all over my head.
Patient returned to pharmacy with a 2" diameter red circle with warm to the touch. Pharmacist recommended patient to see physician because it may be infected.