chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient has a history of COPD on daily prednisone. She was brought to the ED by EMS on 3/13/23 with constipation, nausea, chills, runny nose, and cough. The patient was admitted 3/13/23 for community acquired pneumonia, and she was started on ceftriaxone and azithromycin. Additionally, a COVID-19 PCR test resulted positive. She did not require steroids during her hospital stay.  She was discharged 3/20/23. Of note, the patient has received the primary COVID vaccine series and three booster doses.
Covid vaccine that was administer was accidently stored in the freezer instead of the fridge.  No adverse reactions.
had to deal with a side effect of Bell's palsy; This case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown.   It was unknown if the reporter considered the bell's palsy to be related to Shingles vaccine.  Additional information was provided as follows: The case was reported by patient's son/daughter. The age at vaccination was not reported. The patient got vaccine and had to deal with a side effect of Bell's Palsy. The reporter stated, researched for a different route. The follow-up would not possible as no contact details were available.
Chills, arthralgia of the fingers and back, headache, fatigue, nausea Tylenol 500mg, 4 times a day Resolved in 48 hours
Patient and his mother approached check out on 8/29/23 And I had just began to say we need to update his picture, I looked up @ him he fell forward with no notice. I heard a huge thumping sound - then he was gone from my site - on office floor. I rushed up on my feet to go get help. I was followed by a crowd of people rushing to help. Someone offered to call 911 & my coworker did. Dr said we did not need to call 911 that it was going to be ok. She & the head nurse were attending with his mother so I returned to my spot.
Period has changed. It has been crazy heavy and it happening every 18-21 days.; Period has changed. It has been crazy heavy and it happening every 18-21 days.; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19 The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On an unknown date, the patient's period had changed, it had been crazy heavy and it was happening every 18-21 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, the patient underwent COVID-19 test via nasal swab and the result was unknown. The clinical outcome of the events period had changed, it had been crazy heavy and it was happening every 18-21 days was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PATIENT DIDN'T HAVE VACCINE CARD, AND DID NOT LET US KNOW HE HAD A COVID SHOT ON 8/24/2021 (2ND) AND 1ST ON 7/27/2021. I TOLD HIM I WOULD MAKE A NEW CARD WHILE HE WAITED HIS 15 MINUTES.   HE NEVER STATED HE HAD A SECOND SHOT LAST WEEK UNTIL I WAS GOING TO MAKE HIS CARD. HE HAS NOT COMPLAINED OF ANY SIDE EFFECTS YET.  I WATCHED HIM FOR 45 MINUTES TO ENSURE HE WAS OK.  HE HASN'T HAD ANY COMPLAINTS, BUT I WAS JUST SUBMITTING THIS BECAUSE HE HAD A 3RD DOSE TOO EARLY.
Egg-sized lump at the site of injection; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE MASS (Egg-sized lump at the site of injection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (Egg-sized lump at the site of injection). At the time of the report, VACCINATION SITE MASS (Egg-sized lump at the site of injection) outcome was unknown. Not Provided    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.   The patient is worried about receiving the second dose.  No treatment in addition to concomitant medications have been reported.
This spontaneous report as received from a pharmacist refers to a 55 year old female patient. On an unknown date the patient was vaccinated with GARDASIL injection (dosing regimen unspecified). No concomitant medications reported. On an unknown date inappropriate schedule of drug administration was reported. The pharmacist was reporting that she heard that an unspecified physician administered GARDASIL to an unspecified 55 year old woman on an unspecified date. NO adverse effects reported. No product quality complaint involved. No further information provided. The outcome of the medication error was unknown. Additional information is not expected. Consent to contact reporter was not provided.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm 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 had no relevant medical history. There were no concomitant medications. 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: Negative, notes: Day 7; Negative, notes: Day 8; Negative, notes: Day 9; Positive, notes: Day 10. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Report about COVID vaccine yes, Reporter type patient, Relevant medical history and concurrent conditions, Structured information(Patient episode name) no, Did you the patient previously receive a COVID-19 Vaccine yes, product COVID 19 Treatment, vaccine lot unknown reason unable to locate or read the details, Device timestamp: 21Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
no significant adverse reaction.  It was a medication error.  Patient is only 17 years and Moderna is only approved for 18 years and older.  This error was noted at time of second vaccine.  Patient and his father wanted the second vaccine despite  Moderna not approved for under 18 years.  Side effects, drug not approved for ages under 17 and that this is an experimental drug was discussed with Father and son.  They both agreed  for the patient to get the second Covid vaccine.  Benefit outweighs the risk. I gave consent for the 2nd Moderna vaccine to be given to the patient.
ADACEL was administered to a patient subcutaneously instead of intramuscularly,with no reported adverse event; Initial information received on 03-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient to whom DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] was administered to a patient subcutaneously instead of intramuscularly, with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (strength, formulation was unknown, lot number: U7453AA and expiry date: 29-Jun-2024) via subcutaneous route in unknown administration site for Immunization.  On an unknown date the patient developed a non-serious event of adacel was administered to a patient subcutaneously instead of intramuscularly, with no reported adverse event (incorrect route of product administration) (latency: same day) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pt had vax listed below on 21AUG95 @ approx 145Pm; approx 3PM had an apparent sz w/temp of 103 & was transported to hosp by MD & released;
Covid symptoms; Diarrhea; Red rash; Fever of 101.6; Fast heart beat/Pulse of 100-110; Not having an appetite; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Not having an appetite), PALPITATIONS (Fast heart beat/Pulse of 100-110), COVID-19 (Covid symptoms), DIARRHOEA (Diarrhea) and VACCINATION SITE RASH (Red rash) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in March 2021.    On 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced PALPITATIONS (Fast heart beat/Pulse of 100-110) and PYREXIA (Fever of 101.6). On 27-Jan-2021, the patient experienced VACCINATION SITE RASH (Red rash). On 28-Jan-2021, the patient experienced COVID-19 (Covid symptoms) and DIARRHOEA (Diarrhea). On an unknown date, the patient experienced DECREASED APPETITE (Not having an appetite). On 28-Jan-2021, VACCINATION SITE RASH (Red rash) outcome was unknown. On 01-Feb-2021, COVID-19 (Covid symptoms) outcome was unknown. At the time of the report, DECREASED APPETITE (Not having an appetite) had resolved, PALPITATIONS (Fast heart beat/Pulse of 100-110) had not resolved and DIARRHOEA (Diarrhea) and PYREXIA (Fever of 101.6) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Heart rate: 100-110 (abnormal) 100-110. On 25-Jan-2021, Pyrexia: 101.6 (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Swelling, redness and warm on site of injection.  Aprox 3 inch size  Got little indurated and with cold compress got much better.
Ringing in ears tennitus; muffled hearing in left ear; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 (at the age of 70-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, cholesterol and acid reflux (oesophageal). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amlodipine besylate (MANUFACTURER UNKNOWN) 5mg, unspecified BP med and atorvastatin (MANUFACTURER UNKNOWN) all from an unknown date and unknown if ongoing for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 23Feb2021 at 13:30 (at the age of 70-year-old) as a single dose for COVID-19 immunisation. On 01Apr2021 at 13:45, the patient experienced ringing in ears tennitus and muffled hearing in left ear after the second dose vaccination. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events included treatment with prednisone. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events ringing in ears tennitus and muffled hearing in left ear was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Began getting body aches, sore throat, muscle aches, headache and low grade temp.  this occurred with my first shot too although I think it was more severe with the first one.
This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a 70-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included mastectomy and breast cancer (the patient was 2 years status post mastectomy only no chemotherapy for breast cancer). In June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, myalgia, shivering, headache, feeling down, erythema, tenderness and swelling. On an unknown date, the outcome of the influenza-like symptoms, fever, myalgia, shivering and headache were unknown and the outcome of the feeling down, erythema, tenderness and swelling were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, fever, myalgia, shivering, headache, feeling down, erythema, tenderness and swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 69 or 70 years. The patient received 1st dose at retail and not at the reporting nurse's clinic. The exact date of vaccination was not reported. The patient experienced flu like symptoms consisting of fever, myalgia, shivering and headache and was being down for a week. The patient also experienced local redness, tenderness and swelling lasting a few days. The patient did not want to return for the 2nd dose of SHINGRIX. The nurse did not agree to follow up from GlaxoSmithKline. This case has been linked with the case US2018GSK135816, reported for patient's husband.
I have experienced extreme fatigue, to the point that it is hampering my ability to work.  I have not seen my doctor about it yet.
Immediate hot flashes after both shots; painful as went into arm; pain was so bad the next day i couldn't even lift my arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Feb2021 08:15 (Lot number: EL 9266) at the age of 27 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "moderate-severe asthma" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: PREVIFEM; ARNUITY ELLIPTA. Past drug history included: Amoxicillin, reaction(s): "Allergies"; Azithromycin, reaction(s): "Allergies"; Benzyol peroxide, reaction(s): "Allergies", notes: Benzyol peroxide: Allergies; Sudafed for Heart palpitations; Ceftin, reaction(s): "Allergies". The following information was reported: HOT FLUSH (non-serious), outcome "recovering", described as "Immediate hot flashes after both shots"; PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "painful as went into arm"; VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious), outcome "recovering", described as "pain was so bad the next day i couldn't even lift my arm". Therapeutic measures were not taken as a result of hot flush, pain in extremity, vaccination site movement impairment.  Additional information : Dose 1: 1st shot was immediately painful as went into arm, pain was so bad the next day that patient couldn't even lift her arm. Immediate hot flashes after both shots. It was unknown if patient had Covid prior vaccination. Patient had not been Covid tested post vaccination  No follow-up attempts are possible. No further information is expected.
heart palpatations, heaviness, flush.  did not contact a doctor  two weeks later I had the same symptoms and heart rate as 106 without any exertion.  BP was 129/74 but hear rate was 106.  went to ER.  diagnosed with heart attack and got a stent in Left anterior descending artery.
Fatigue started about four hours after vaccination; started to resolve twelve hours after vaccination; normal thirty hours after vaccination
In this case, patient is <18 years of age and received the Moderna Vaccine, dose #1.
101.5 degree fever, chills, dizziness, tiredness, joint pain (L) leg, feeling unwell, swollen lymph nodes (L) armpit Lasted 24 hrs Slept most of the time treated with Advil
Urticaria developed 36 hours post vaccination and continued as patient developed symmetric, multiple joint swelling and arthritis, fever, c/w serum sickness reaction. Responded well to 5 days ORAPRED 2 mg 1 BID and antihistamine. On 3/14/13 there was no residual rash / arthritis.
Swollen/red/itchy/slight fever.  Same reaction as last year.  Went away a week ago.
About 12 hours after the shot I felt like I was getting the flu.  I had aches and pains and chills .  Luckily I hadn't eaten in hours so I felt full but did not feel nauseous.  Just kept burping.  I also had head congestion.  I went to bed before 8 PM and got up at 7 am.  11 hours sleep.  I still did not feel better until about noon the next day.
Client given injection, within 3 min she complained of neck hurting, blurred vision, loss of hearing felt weak, hot pulse 96 epi. administered per protocol - EMT arrived in 10 min. - pt didn't lose consciousness - experienced shortness of breath - faint.
Left shoulder pain especially upon movement occured 2-3 weeks after injection. PCP seen in 7/03 and started on Bextra 20 mg daily for inflammation. Pt was referred to Orthopedic. Had x-ray and injected with Cortisone and MRI ordered. On 8/23/03 saw MD for tachycardia and bradycardia. PLaced on Holter monitor. Results-SVT, Tachycardia and Bradycardia. Referred to Cardiac MD.
Local reaction to immunization, no fever. (L) arm with erythema meaning 10 x 10 cm central induration of approx 4 x 4 cm, mother instructed cool compresses. 25 mg of BENADRYL given at clinic.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 07-NOV-2012 at 01:20, 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.
no adverse events; Patient was administrated an expired dose of Varivax; Patient was administrated an expired dose of Varivax; This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, historical drugs or allergies were not reported. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT).       On 23-APR-2019, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) reported lot number N012486 with expiry date 20-APR-2019 (strength, dose, route and frequency were not reported) for prophylaxis.  No adverse effects were reported.  No product quality complaint was filed.  Lot number N012486 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck), expiration date reported as 20-APR-2019, but upon internal validation established as 24-APR-2019.
Pt given booster dose on 4/21/22 from a vial that expired on 4/18/22. Moderna was contacted and their report shows that the dose maintained the necessary protection so no repeat dose was recommended to the patient.
EUPHORIA; This spontaneous report received from a health care professional 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported 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 euphoria. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of euphoria was not reported. This report was non-serious. This case, from the same reporter is linked to 20211114935.
Beginning day after vaccine, patient had redness at injection site, warm painful sensations, surrounding skin felt swollen/hard to the touch. Patient did not self-treat symptoms and symptoms were persistent until day of report.