chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vial was not completely in liquid state prior to the administration; This spontaneous case was reported by a consumer and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vial was not completely in liquid state prior to the administration) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vial was not completely in liquid state prior to the administration). On 18-Aug-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vial was not completely in liquid state prior to the administration) had resolved.            No concomitant medication was provided. No treatment medication was provided. Reporter reported that the vial was not fully thawed and the administrator warmed it in her hand "was almost fully liquid" before administration.  Nurse stated that she took the vial out of the freezer in the morning around 7AM and the vial thawed for 2 hours but was not completely in liquid state prior to the medical assistant administering the dose to the patient.   Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Follow-up received and contains nonsignificant information.
DTaP was administered instead of Tdap on a teenager patient/no AE; Initial information received on 27-Jun-2020 regarding an unsolicited valid non-serious case received from a non health care professional.  This case involves a teenager patient(exact age and gender not known) who was vaccinated with DTAP [ DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE] instead of TDAP[ DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE](batch number, dosing details and expiry date not reported)  via unknown route in unknown administration site on an unknown date for prophylactic vaccination(Wrong product administered).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was of actual medication error case due to wrong vaccine administered.  At the time of reporting, no adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.  There will be no information available on batch number for this case.
p/vax pt exp flushing & swelling on arms, chest & face;prescribed medrol dose pak & DPH;
He has not had any symptoms since this episode of paralysis; Started to sweat; Couldn't move at all for 30 minutes; He tried to scoot off the bed and go to bathroom but ended up on the floor; Felt cold; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (He has not had any symptoms since this episode of paralysis) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pacemaker insertion (cardiac) (Pacemaker). Concurrent medical conditions included Anaemia and Autoimmune disorder.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, the patient experienced PARALYSIS (He has not had any symptoms since this episode of paralysis) (seriousness criterion medically significant), HYPERHIDROSIS (Started to sweat), MOBILITY DECREASED (Couldn't move at all for 30 minutes), FALL (He tried to scoot off the bed and go to bathroom but ended up on the floor) and FEELING COLD (Felt cold). On 25-Aug-2021, PARALYSIS (He has not had any symptoms since this episode of paralysis), HYPERHIDROSIS (Started to sweat), MOBILITY DECREASED (Couldn't move at all for 30 minutes), FALL (He tried to scoot off the bed and go to bathroom but ended up on the floor) and FEELING COLD (Felt cold) had resolved.            No concomitant medication was given. No treatment medication was given.  Company Comment: A 75-year-old male, with pacemaker, presented with serious unexpected paralysis, and non-serious hyperhidrosis, mobility decreased, fall and feeling cold. Latency 224 days after first dose, 197 days after second dose, and 1 day after third dose. Events resolved. Rechallenge not applicable. Reporter causality not provided. Causality possible based on temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: A 75-year-old male, with pacemaker, presented with serious unexpected paralysis, and non-serious hyperhidrosis, mobility decreased, fall and feeling cold. Latency 224 days after first dose, 197 days after second dose, and 1 day after third dose. Events resolved. Rechallenge not applicable. Reporter causality not provided. Causality possible based on temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Moderna COVID-19 Vaccine day after injection noticed some soreness and puffiness at the injection site and a red area right below the sight the size of a silver dollar that was warm to the touch.  On 1/13/21 the red area was larger (2 1/2 inches by 2 1/2 inches) was still warm to the touch and felt hard.
pt recv vax; c/o fever, HA, body aches, nausea, rxn occurred w/in 24 hr & lasted 6 days;
Date of Admission:                10/21/2022 Date of Discharge:                10/25/2022   Discharge Diagnoses: Active Hospital Problems   Diagnosis o Principal Problem: Cavitary lesion of lung o Gastroesophageal reflux disease without esophagitis o Lipedema o Bronchiectasis (CMS/HCC) o Positive ANA (antinuclear antibody) o Age-related osteoporosis without current pathological fracture o PUD (peptic ulcer disease)
Presented to the ER with dyspnea. Brought by ambulance from  where he lives. Please note-this chart is entered after a review of all patients presenting to the hospital with diagnosis of DVT, PE or stroke since we started vaccinating for Covid-19 on 12/23/2020.  He got a pfizer vaccine on 1/30/2021.  We pulled all charts of theses diagnosis if it occurred within 14 days of vaccination.
Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9809), via an unspecified route of administration in the left arm, on 13Feb2021 15:00, as single dose, for COVID-19 immunisation. Medical history included asthma. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included formoterol fumarate, mometasone furoate (DULERA); and morniflumate (FLOMAX), both taken for unspecified indications, start and stop dates were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) received at age 68 years, via an unspecified route of administration in the left arm, on 23Jan2021, for COVID-19 immunisation. The patient received other vaccines (unspecified) within 4 weeks prior to BNT162B2. On 20Mar2021 at 09:00, the patient developed compromised taste sensations, could not form a tight seal around mouth, was spilling fluids from right side, and could not close right eye. He was diagnosed with Bell's Palsy. The event resulted to physician office visit. Treatment for the event included unspecified anti-viral tablets (as reported). Laboratory test include COVID-19 PCR test which was negative on 23Feb2021. The outcome of the event was not recovered.  No follow up attempts are needed. No further information is expected.
Moderna COVID-19 Vaccine EUA.  About 1 week after receiving the vaccine, the injection site on my left arm turned bright red and extremely itchy.  One week later, the redness has expanded around the site and is still itchy, but my skin is not as bright red.  Skin is pink with a distinct line circling the affected area.
Started with hives spreading from head to trunk and down. They disappeared after 15 minutes while calling the dr to see if he needed to be seen. They advised it was a reaction and not to worry. He screamed and cried that night, then began refusing all table food which he had been eating and reverted to baby food. As of 6/17/2012 he still refuses food except baby food. Currently in the local infant and toddler program for hypotonia, lack of speech and occupational therapy.
Left arm redness, sore, swelling 2 hrs after shot - DTAP given.
received the vaccine and she's a nursing mother; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BREAST FEEDING (received the vaccine and she's a nursing mother) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced BREAST FEEDING (received the vaccine and she's a nursing mother). At the time of the report, BREAST FEEDING (received the vaccine and she's a nursing mother) 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.   No relevant concomitant medications were reported. No treatment information was provided.
Patient was given ZOSTAVAX injection 9-18-09 - pt was seen & diagnosed with shingles 06/11/12. Pt is currently on dose of Prednisone for 6 days. Took 2 days.
c/o inc tenderness, arthralgias lt shoulder w/dec ROM 2 days p/3rd inject of Engerix-B; 1st 2 vax were uneventful;
Starting on 10/6/2021 I had swelling under my left arm and a 102 fever. I took Tylenol for the fever.  On 10/7/2021 and continuing, I still have the swelling under my arm which has gone into my left breast, my left breast is visably swollen, there is more swelling on my left sholder into my neck and down my back.  My left arm is swollen and the sleeves of my shirts on the left side are noticibly tighter than on the right, my bicep is swollen and is painful.  I feel pain in my neck, most likely from the swelling.
Patient developed warm red induration adjacent to injection site, starting the days she received the injection. When the patient came in 2 days later on Saturday, it was warm to the touch and was still warm, red and swollen. The pharmacist referred patient to seek medical care. The patient was assessed at an urgent care and given an antibiotic.
Extremely high fever of 105 for 8hrs, severe headache, neck pain and fatigue.
8 days after the vaccine patient reports a red rash on arm that extended to his elbow. Called his PCP who started him on a short course of prednisone.  The arm has improved and resolved as of March 8th.
I got the Shingles shot a couple years ago & I still came down with them/ Suspect vaccination failure; I still came down with them/still have a few that still bothers me.; A few that still bothers me; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and discomfort. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and discomfort were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and discomfort to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. A couple years ago, the patient received Shingles vaccine and still came down with shingles. The patient stated that it had been 8 weeks so far and most of them had disappeared but still had a few that still bothers him/her. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming herpes zoster were unknown at the time of reporting.
On 02/009/05, eleven days after vaccination client noted a quarter sized red, raised, warm tender lump at the back of left arm at about the the injection site, which subsided slowly over the next week. On 02/15/05, another lesion cropped up on the opposite arm, described as dime size but the same. No vesicules noted.
This spontaneous report as received from a pharmacist refers to a 62 year old female patient. The patient had none pertinent medical history. The patient had none drug allergies. On 18-JAN-2013 the patient was vaccinated subcutaneously with live ZOSTAVAX (lot # H016762, expiry date 11-DEC-2013). Concomitant medication was reported as none. "At some point the following week", in approximately January 2013, the patient developed a rash which was hot and red and two to three inches wide. The rash disappeared for a few days and had reappeared at the time of reporting as little red bumps but was not irritating. The patient sought for medical attention by calling the reporting pharmacist. No treatment was given. Lab diagnostics studies performed were reported as none. The outcome was reported as not recovered. Additional information is not expected.
Client given vaccines in am, at about 8 pm of same day client started vomiting and developed a low grade fever (99.8). Client cont to have nausea and vomiting, low grade fever into the next day.
While sitting down after vaccination, right before his sister was about to receive her vaccine, patient suddenly lost consciousness and started to slump down. He was caught quickly by his mother and was laid down on the floor. He woke up about ten seconds later. He was treated with smelling salts, apple juice, lollypop and did well. Also he complained of stomach pain which resolved.
The patient was brought to Medical Center on 02/18/2022 by her daughter for worsening confusion, generalized weakness, and new urinary incontinence and was refusing to eat/drink, or walk.   The patient tested positive for Covid-19 on 01/19/2022.   CT abdomen pelvis on 02/18/2022 showed moderate bilateral pleural effusion with overlying atelectasis/consolidation.  Due to the patient's multiple comorbidities, palliative care was consulted, and decided that the patient would be discharged home on hospice care.  The patient was discharged on 02/25/2022.  The patient expired on 03/08/2022.
Vomiting, hives, coughing, trouble breathing, blood shot/swollen eyes, rapid heart rate...vomiting started almost instantly then the rest of the symptoms came with in 15 minutes, I rushed him to the hospital and he was given a shot of Benadryl and steroid and was sent home with steroids and Benadryl...anaphylactic response to H1N1 vaccine with no history of adverse affects from any other vaccine.
Patient was admitted in the hospital; This spontaneous case was reported by a consumer and describes the occurrence of HOSPITALISATION (Patient was admitted in the hospital) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Nov-2021, the patient experienced HOSPITALISATION (Patient was admitted in the hospital) (seriousness criterion hospitalization). The patient was hospitalized on 06-Nov-2021 due to HOSPITALISATION. At the time of the report, HOSPITALISATION (Patient was admitted in the hospital) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Patient was scheduled to take second dose on 06 Nov 2021 but he stayed in the hospital for a week for another condition that the caller mentioned it was unrelated to the vaccine. No treatment information was provided.  Company comment This case concerns a 26 year-old, male patient with no relevant medical history, who experienced the serious unexpected event of Hospitalisation. The event occurred approximately 19 days after the first dose of mRNA-1273 vaccine. The reporter stated the patient has hospitalised a week for another condition that was unrelated to the vaccine. The rechallenge was unknown since the event occurred after the first dose and no information has been provided regarding second dose. The event was considered unrelated to the vaccine per the reporter's assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2021: Follow up received contains no new information.; Sender's Comments: This case concerns a 26 year-old, male patient with no relevant medical history, who experienced the serious unexpected event of Hospitalisation. The event occurred approximately 19 days after the first dose of mRNA-1273 vaccine. The reporter stated the patient has hospitalised a week for another condition that was unrelated to the vaccine. The rechallenge was unknown since the event occurred after the first dose and no information has been provided regarding second dose. The event was considered unrelated to the vaccine per the reporter's assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Information has been received from a nurse practitioner concerning a patient who was vaccinated with a first dose of Gardasil.  About one month after vaccination the patient returned to the office and complained of injection site soreness.  She was examined and was found to have a small bump at the Gardasil vaccination site.  The bump was the size of 1/2 of a pee.  At the time of the report the patient's outcome was unknown.  Additional information has been requested.
started the day following vaccination with a cherry red under the nose  to top of the upper lip that grew larger, was not painful, did not itch.  then approx 4th day after the vaccine face started discoloring both sides of the cheeks and the chin specifically; another cherry red spot developed on the bottom right lip.  Saw PCP who prescribed AV cream to be applied to these areas which did help. Also has had some similar discoloration on right arm and on her chest.  Scheduled to see dermatologist in August 2022 ( reports she has already been going to see Dr. for other skin issues in the past)
fever; hives; nausea; headache; body ache; This is a spontaneous report from a contactable consumer or other non hcp.   A 32-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0158), dose 2 via an unspecified route of administration, administered in Arm Left on 14Apr2021 at 08:00 (at the age of 32-years-old) as dose 2, single for covid-19 immunisation. The patient was allergic to Avocado, herbal medicine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included acetaminophen; vitamin c [ascorbic acid]; cordyceps sinensis, ganoderma lucidum, lentinus edodes, trametes versicolor, tremella fuciformis (MUSHROOM 5 COMPLEX). The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8732) dose 1 via an unspecified route of administration, administered in Arm Left on Mar2021 for covid-19 immunisation. On 14Apr2021, the patient experienced body ache in unspecified time, hives at 20:00, headache at 02:00, fever at 20:00 and nausea at 20:00. It was reported that after receiving the second vaccine, from 12 hours after, the patient experienced general body ache and headache. Between 24-36 hours, symtoms (high fever, headache, general body ache, nausea etc.) became severe. 5 days after the second vaccination, sudden hives (inflammatory hives) occurred and the hives area continued to become wider and also, after the first dose, the patient had high fever, general body ache, nausea and headache. Since the vaccination, the patient has been tested for COVID-19. The adverse event resulted in Emergency room/department or urgent care. Upon follow up on 21Apr2021, details with pregnancy information, lot number date and time of vaccination was updated. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 19Apr2021. Treatment was given for the adverse event with Benadryl and hydrocortisone cream. Outcome of the events were not recovered.  Follow-up (21Jun2021): Follow-up attempts completed. No further information expected.
No adverse symptoms reported; vaccinated wilh improperly stored VARIVAX; This spontaneous report was received from a physician referring to a 5 year old male patient. Information about pertinent medical history, concomitant medications and drug reactions or allergies was not provided.    On 27-NOV-2019, the patient was vaccinated with improperly stored dose(1 dosage form) of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S019581, expiration date 25-JUN-2021, route, anatomical location and strength were not provided) for prophylaxis (product storage error). No adverse effects were reported. Administered doses of vaccine experienced temperature excursion from -50 degrees Celsius (C) to -15 C (-14.67C) for 3 hours. Total time in the range from 6 degrees Fahrenheit (F) to 14 degree F (-14 degree C to -10 degree C) (-14.4C) for 3 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint (PQC) was involved with this report.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA006288:
approx 5 mins p/vax pt fainted w/o warning sound; was initially pale, cold, clammy; no resp diff; unconscious only momentarily; color, skin, temp & awareness returned fully p/30mins;
July 1st: admitted for papilledema, new demyelinating lesion on brain MRI; new labile hypertension; found to NOT have MS per neurology 8/15: admitted for crushing chest pain, elevated troponin; had normal heart catheterization and +myocarditis on heart MRI Between those two events he developed severe abdominal pain and new severe constipation with ER visit with normal CTA of chest/abdomen/pelvis; not clearly related to other concerns.