chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever 3pm malaise an tiredness; chills at 3am on 1/12/2021 Narrative:
Slept the whole next day; soreness; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Slept the whole next day) and PAIN (soreness) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal.    On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced PAIN (soreness). On 16-Feb-2021, the patient experienced SOMNOLENCE (Slept the whole next day). On 16-Feb-2021, SOMNOLENCE (Slept the whole next day) had resolved. At the time of the report, PAIN (soreness) outcome was unknown.            Concomitant medications stated Blood pressure medication. No treatment details were reported.   This case was linked to MOD-2021-364344 (Patient Link).
Day after the shot-headache, tired, spiked a fever, achy, chills, shaking. Ever since, injection site swollen, itchy, painful.
difficulty of breathing; After having the virus, he got pretty sick; COVID-19; Lack of efficacy; low-grade fever with body temperature of 99 degrees Fahrenheit; soreness of his arm; cough; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty of breathing) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A2A1 and 0311720A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy and Degenerative bone disease (Degenerative Disease).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness of his arm), COUGH (cough), DIARRHOEA (Diarrhea) and PYREXIA (low-grade fever with body temperature of 99 degrees Fahrenheit). On an unknown date, the patient experienced DYSPNOEA (difficulty of breathing) (seriousness criterion hospitalization), COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of efficacy). an unknown date, the patient experienced ILLNESS (After having the virus, he got pretty sick). At the time of the report, DYSPNOEA (difficulty of breathing) had resolved and PAIN IN EXTREMITY (soreness of his arm), COUGH (cough), DIARRHOEA (Diarrhea), ILLNESS (After having the virus, he got pretty sick), COVID-19 (COVID-19), DRUG INEFFECTIVE (Lack of efficacy) and PYREXIA (low-grade fever with body temperature of 99 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Body temperature: 99 (High) 99 degrees Fahrenheit. On 27-Jul-2021, SARS-CoV-2 test: positive (Positive) positive with Corona Virus.         Additional medical history includes history of VA . Treatment information was not provided.  Company Comment: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the rest of the events: 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. This is also a report of "drug ineffective".; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the rest of the events: 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. This is also a report of "drug ineffective".
24 hours after inj L axillary LN enlarged about the size of a baseball very tender and warm to the touch. Also swelling on L side of chest. Taking nsaid ATC but pain and swelling has persisted - pressure radiates to L scapula.
fever, nausea, dizziness.  Lack of appetite. Headache. Body aches. Swollen lymph nodes in under arm. Rib and shoulder blade pain, shortness of breath. Extreme exhaustion.   Symptoms began around hour 18. Most severe between hours 20 and 36. Now nearing hour 80 and still have rib and shoulder pain on left side making it hard to take deep breaths. Other symptoms ceased at hour 60.
having I think allergic reaction; It's red and it's raised all the way down to her, close to her elbow but it's not all the way; welt and a lump under the skin" where she received her injection; welt and a lump under the skin" where she received her injection; its been hurting her; This is a spontaneous case is received from a contactable consumer (boyfriend).   A 29-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history included allergic reaction for flu shots. The patient's concomitant medications were not reported.  On an unspecified date the patient had allergic reaction. Its red and raised all the way down to her, close to her elbow but not all the way. It had been hurting her and reporter was wanted some information and requested for call back. On call back, it was reported that she had a welt and a lump under the skin where she received her injection. Reporter wanted to know if allergic reaction was normal for vaccine and also duration for the same. The reporter was informed about the listed events and duration. Outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Body aches; Chills; Fever; Nausea; Arm soreness; Fatigue; Weakness; Near-fainting; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old, non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN) via unspecified route of administration in the left arm on 26Mar2021 at 08:45 (age at vaccination 56-year-old) as a single dose for COVID-19 immunisation . Medical history included hypogammaglobulinemia. The patient reported allergies to sulfa, fluoroquinolones, ambien, vicodin, nickel. Concomitant medications included vitamin D (MANUFACTURER UNKNOWN), vitamin C (MANUFACTURER UNKNOWN), probiotic (MANUFACTURER UNKNOWN), famotidine (MANUFACTURER UNKNOWN) for an unknown indication and from an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19 on unspecified date. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 26Mar2021 at 08:45, the patient experienced body aches, chills, fever, nausea, arm soreness, fatigue, weakness and near-fainting. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic treatment were taken for the reported events. The clinical outcome of the events of body aches, chills, fever, nausea, arm soreness, fatigue, weakness and near-fainting were resolved with lasting effects.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
BLOOD CLOTS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, with frequency 1 total administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clots. It was reported that the patient experienced blood clots after receiving the vaccination for which the prison has failed to provide the medical treatment. The action taken with covid-19 vaccine was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: covid-19 vaccine Blood clots. 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).
This spontaneous report as received from a pharmacist refers to a newborn (male) patient of unknown age. On 23-OCT-2012 18:42, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Aches in my body; Joint pain; Tiredness; A low-grade fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches in my body), ARTHRALGIA (Joint pain), FATIGUE (Tiredness), PYREXIA (A low-grade fever) and CHILLS (chills) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021 at 7:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN (Aches in my body), ARTHRALGIA (Joint pain), FATIGUE (Tiredness), PYREXIA (A low-grade fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Aches in my body), ARTHRALGIA (Joint pain), FATIGUE (Tiredness), PYREXIA (A low-grade fever) and CHILLS (chills) outcome was unknown.        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 relevant Concomitant medications were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Feb-2021 and was forwarded to Moderna on 26-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches in my body), ARTHRALGIA (Joint pain), FATIGUE (Tiredness), PYREXIA (A low-grade fever) and CHILLS (chills) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021 at 7:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN (Aches in my body), ARTHRALGIA (Joint pain), FATIGUE (Tiredness), PYREXIA (A low-grade fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Aches in my body), ARTHRALGIA (Joint pain), FATIGUE (Tiredness), PYREXIA (A low-grade fever) and CHILLS (chills) outcome was unknown.        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 relevant Concomitant medications were reported.
Case number PHEH2014US015267 is an initial spontaneous report from a nurse received on 30 Jul 2014 with a follow-up received on 22 Aug 2014. This report refers to an 11-year-old male patient. Past medical history was not provided. Concomitant vaccination included BOOSTRIX (other manufacturer and batch number: STN9R). On 24 Jul 2014, he was vaccinated an intramuscular dose of MENVEO (batch number: A14021) where MenA lyophilized conjugate component reconstituted with a sterile water (other than MenCWY). It was reported that the patient needs to repeat MENVEO dose for maximum benefit. No adverse event was reported following this administration error (wrong solution used in drug reconstitution). Follow-up received from a nurse on 22 Aug 2014: Patient's demographics (height and weight), concomitant vaccination and narrative updated.
On December 14th 2022 in the evening I had a cough.  On Thursday December 15th the cough progressively got worse.  Friday morning December the 16th I was ok but had a cough throughout the day.  My sister gave an N95 mask to wear on my flight home.  I progressively got sicker and sicker on my flight home.  At about 2am I took a COVID-19 home test which was positive.  By 9am I was starting to have chills, fever of 102 degrees. My chest felt very congested.  I had a great deal of malaise, congestion, and coughing fits.  No sore throat. My husband took me to emergency room at 11:45am.  I was x-rayed and blood drawn.  While I was in the room, I had a coughing fit so severe that I couldn't breathe.  I couldn't catch even a partial breath.  My husband brought the doctor in.  I was trying to keep straight to keep my airway open.  They laid me back down.  They were able to calm me down enough to be able to catch a breath.  My oxygen sats were perfect.  They said I was having a panic attack because I couldn't catch my breath.  I didn't need any breathing treatments or anything like that.  They gave me Ativan to calm me down.  That allowed me to calm down and sleep.  While I was asleep they gave my husband my prescriptions to fill.  When I woke up I was cleared to go home.
Severe abdominal cramping, diarrhea, rectal bleeding. Went to ED.
Patient was given the Pediarix combination vaccine (dtap,hep b,ipv).  This vaccine is not recommended for his age group.  Patient should have received tdap,hep b,ipv.  Per CDC, and Glaxosmithkline no known adverse effects and patient does not need to be revaccinated.
ACUTE RESPIRATORY FAILURE 9/10/2021 DIASTOLIC HEART FAILURE, ACUTE ON CHRONIC ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 9/10/2021 DIASTOLIC HEART FAILURE, ACUTE ON CHRONIC ACUTE RESPIRATORY FAILURE 9/10/2021 CKD STAGE 3 (GFR 30-59), UNSPECIFIED. ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 9/10/2021 CKD STAGE 3 (GFR 30-59), UNSPECIFIED.
Per patient she developed a rash after showering on 9/13/18 10am, she went to the doctor and was diagnosed with cellulitis. Patient received Clindamycin 300mg three times a day for 10 days as treatment
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 61 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 02-SEP-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for prophylaxis (age at vaccination was reported as 60 years old). As a result of her receipt of zoster vaccine live (ZOSTAVAX), on 27-JUL-2016, the patient was caused to suffer shingles, including any and all of its sequelae and had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain. As a result of her receipt of zoster vaccine live (ZOSTAVAX), the patient suffered shingles and other related health complications. In addition, the patient requires and will continue to require healthcare and services. The patient has incurred and will continue to incur medical and related expenses. The patient also has suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The patient's direct medical losses and costs include physician care, monitoring, and treatment. The patient has incurred and will continue to incur mental and physical pain and suffering. The outcome of the event was considered not recovered/not resolved. The event was considered related to zoster vaccine live (ZOSTAVAX).   The lawyer considered the event to be medically significant and disability.
Red, itchy splotch on skin directly below injection site. Also bruising at injection site.
patient inadvertently received an expired 3rd dose; patient inadvertently received an expired 3rd dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 35-year-old female patient who received HAV (Havrix) (batch number 37RY4, expiry date 6th March 2021) for prophylaxis.   Previously administered products included Havrix (received 1st dose on 3rd November 2020). Concomitant products included HAV (Havrix).   On 28th June 2021, the patient received the 3rd dose of Havrix (intramuscular). On 28th June 2021, unknown after receiving Havrix and 23 days after receiving Havrix, the patient experienced extra dose administered and expired vaccine used. On an unknown date, the outcome of the extra dose administered and expired vaccine used were unknown.  Additional details were provided as follows: The patient received the second dose of Havrix on 5th June 2021and completed the series. However on 28th June 2021, the patient inadvertently received an expired 3rd dose of Havrix on left deltoid, which led to extra dose administered and expired vaccine used. The reporter consented to follow up.
Had no symptoms after dose #1 other than a mildly sore arm. Expected same reaction after dose #2, but by the evening of 8/26/2020, started to feel achy and headache. In the middle of the night woke feeling as if I had the flu - alternating chills and too hot and aching becoming worse. Took Tylenol, which helped for a bit. After waking later in the morning, the chills and aches were worse than overnight and able to take my temperature - 103-104. Remained in bed from the afternoon into the evening and because of severe aches needed help to get out of bed. Continued to take Tylenol but it would only help for about 1 hour. By the morning of 8/28/20 the fever, chills and aches finally subsided so that I could get out of bed and function. Took 2 more days to finally feel "normal".
Within days of this shot I experienced stroked like symptoms and had to have an MRI. Itook a hard fall inside our home and suffered a bad concussion. My speech was slurred, he could not put a sentence together. Before getting this shot we had both had COVID-19 and it did hit us both pretty hard.    Since I have had this shot my cognitive abilities have slowly declined and they have n explanations. My short term memory, my speech, my vision, and my hearing have all declined.   They have declined to a point to where some days I do not leave our bedroom. I have trouble recalling conversations or events that may have happened just a few hours earlier.   I have seen two Neurologist and a Neurosurgeon-  One MRI stated brain Atrophy in a July 2022 MRI
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 68-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "follicular lymphoma" (unspecified if ongoing); "Afib" (unspecified if ongoing). Concomitant medication(s) included: AMBIEN; DILTIAZEM; ELIQUIS; LEVOTHYROXINE; REVLIMID oral, start date: 01Oct2021, stop date: Nov2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Positive, notes: test positive for Covid via rapid test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Paxlovid was taken as therapeutic measures for drug ineffective, covid-19 from 27Oct2022 to 01Nov2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As per the available information the causality of the events drug ineffective and covid-19 with suspect BNT162b2 can not be ruled out completely.
Rash and fever for 2 days following shot. 5 days later fever again. Ear infection. 71 days later ERYTHEMA MULTIFORME RASH broke out all over body.  Ears,wrists,ankles swelled up, fever 103. Sneezing,swallowing hard,not sleeping, crying uncontrollably,restless. Tried Benadryl but nothing helped.  Dr gave steroids. Saw 2 Dr's who didn't know what it was...Told me it was not from vaccine.  The Merck web site says it is one of the reactions!!!!!!
Tingling mainly up neck and face about 5 minutes after injection.  Lasted about 20 seconds
Patient was given Tdap instead of DtaP (infantrix) vaccine  Medication error
Shortly after the patient received the vaccination, the patient stated that he felt something. He ended up fainting and hitting his head on the floor. We were able to get him up and he regained consciousness within the minute.  He seemed confused initially. We had him sit for observation and monitored his blood pressure. The results of his blood pressure was significantly low. His status (consciousness) seemed to have improved, but due to precautions and his blood pressure, we recommended that he gets seen by a professional. His significant other that was present with him said that they will be heading to an urgent care.
Mild varicelliform rash and pneumonitis occurring a week after vaccine adminstration.
having a dry mouth, attitude started to change, tiredness, having breathing problems, went to the hospital passed out in coma for 24 days and died 3 times.
Morning after receiving MMR shot, my son is having trouble walking. He can not stand still for long.  He trips and falls and collapses on the floor.  He will just sit all day and now will not even attempt to walk.