chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 9 years old male patient who received vaccine QUADRACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 02-Oct-2018, the patient received a  dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C54998A. It was a case of actual medication error due to Inappropriate age at vaccine administration. 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.
Woke up at 2 am with chills and body aches. It got progressively worse and brought me to tears (unusual for me). Headache, vomiting and the most severe body aches I?ve ever experienced. This continued till 9am and started to ease.
This spontaneous report was received from a licensed practical nurse refers to multiple unspecified patients of unknown demographics. The patients concurrent conditions and medical history were not provided. On multiple unspecified dates, the patients were vaccinated with unspecified improperly stored doses GARDASIL lot# J006236 with expiration date 25-FEB-2016 and lot# K005881 with expiration date 14-JAN-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effect reported. This is one of several cases from the same reporter. Follow up information has been received on 20-OCT-2015, a phone call was placed to the reporting licensed practical nurse who reported that she would have to research the request made for patients identifiers, lot number and expiration date and dates of vaccination. Additional information has been requested.
Won´t be able to assist to the second dose; This case was reported by a nurse via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a female patient who would receive Rabies NVS (RabAvert) (batch number ARB6631A, expiry date 20th November 2021) for prophylaxis.   Previously administered products included Rabavert (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of RabAvert. On an unknown date, unknown after receiving RabAvert, the patient experienced circumstance or information capable of leading to medication error. On an unknown date, the outcome of the circumstance or information capable of leading to medication error was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The patient won´t be able to assist to the second dose of Rabavert.  So, they ask if it would it be correct to administer one day before or one day after, which led to circumstance or information capable of leading to medication error. The reporter consented to follow up.  Nurse provided consent to follow up. All patient identifiers were given as well as the batch number and expiration date for Rabavert.
received shingrix vaccine on 5/13 and started having mild pain off and on.  by 5/18 symptoms got more severe. symptoms including raising arm with pain, lessen range of motion, and weakness in the hand. then off and on until now some days have been better but in the last 2 weeks, symptoms have not gotten milder but staying constant and also pain wakes patient up. pt has been taking aleve and excedrin migraine on a daily bases and using cold and warm compresses.
Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the onset date of diarrhea, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of diarrhea, a causal relationship cannot be excluded.
Fever, chills, body tremors, nausea, headache, muscles pain, joint pain, abdominal pain, diarrhea, insomnia, dizziness, blurred vision, kidney pain, lightheadedness
Eczema; This spontaneous case was reported by a patient and describes the occurrence of ECZEMA (Eczema) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 048B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2022, the patient experienced ECZEMA (Eczema). At the time of the report, ECZEMA (Eczema) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications provided by the reporter. Patient experienced symptoms of itchiness, rash, and felt annoyed and sleeplessness.  Diagnosis of eczema was received on May-2022. Patient treatment medication included  cream, oral steroids, topical steroids. Patient also read on internet that Moderna vaccination was associated with delayed skin conditions.   Most recent FOLLOW-UP information incorporated above includes: On 24-Aug-2023: Live follow up has been appended.
This spontaneous report as received from a physician refers to an infant patient of unknown age and gender. No medical history or drug reactions/allergies were reported. Approximately 2 months ago, in approximately June 2013, the patient was vaccinated with the second dose of ROTATEQ (lot# and dose not reported) oral. The physician reported that in approximately June 2013, after administering the second dose, the infant developed bloody stool and diarrhea and was diagnosed with colitis. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital 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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient got shingles after several years later receiving the shot. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case has been linked with US2021AMR178194, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178194:same reporter
Soon after my booster shot, my right knee was showing signs of pain. It feels like it has fluid on it. The pain is also in my leg. It feels as if my leg is falling asleep. It feels like the same kind of pain in my arm, like I received the shot in my leg. It's the same kind of pain. I'm waiting on a appointment with my doctor. I have never had this pain before. It hurts to where I can not get up sometimes. I must sit down often at work.
Same day tunnel vision and light headed, muscle weakness.  24h after, body aches and headache, low energy. Swollen lymph nodes in left armpit to size of grapefruit hemisphere and right armpit to lesser degree day 2-5 after injection, tender to pressure and weight of arm against armpit.  Swollen mid jawline at submandibular glands, bilateral, equal size, tender to touch day 4-5.  Left more pronounced.  Tender pain and stiffness  at base of skull uppermost vertebrae of neck.
experienced pain all over; fever of 100.5 degrees Fahrenheit; chills; headaches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (experienced pain all over), PYREXIA (fever of 100.5 degrees Fahrenheit), CHILLS (chills) and HEADACHE (headaches) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PHENYTOIN (DILANTIN [PHENYTOIN]) for an unknown indication.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, the patient experienced MYALGIA (experienced pain all over), PYREXIA (fever of 100.5 degrees Fahrenheit), CHILLS (chills) and HEADACHE (headaches). At the time of the report, MYALGIA (experienced pain all over), PYREXIA (fever of 100.5 degrees Fahrenheit), CHILLS (chills) and HEADACHE (headaches) outcome was unknown.     Treatment medication was 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.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jul2021 at 14:00 as dose 2, single (Batch/Lot number: unknown) at the age of 63 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies:Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19. Clinical course: The patient previously received COVID-19 Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Jerked arm; Patient did not receive full dose; This is a spontaneous report from a contactable physician via a Pfizer Sales Representative. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration in arm on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced jerked arm when receiving injection on an unspecified date. Patient did not receive full dose. The outcome of event was unknown.  No Follow-up attempts are possible. No further information is expected.
After 1 day, patient noticed redness / rash at the injection site. Patient contacted us at the pharmacy to report that the rash/redness had moved down her upper arm and is now above and on her elbow.
Caller was tested Covid19 Positive; This is a spontaneous report from Pfizer Sponsored Patient Support Program COVAX US Support report from a contactable consumer (Patient). A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported),  via an unspecified route of administration on 25Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  on 05Apr2021, The patient experienced caller was tested covid19 positive (covid-19). The patient underwent lab tests and procedures which included sars-cov-2 test: positive on. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Tells me he received Janssen vaccine on 7/7. The following day starting having fever and chills. Symptoms worsened the next day with lower abdominal pain. He then went to ED for evaluation which revealed appendix was dilated ultimately resulting in laparoscopic appendectomy.
Two weeks after receiving a booster dose of Moderna I developed severe, itchy hives that covered my entire body. The hives lasted seven months.  After the booster wore off, hives ended for two weeks before I contracted Covid-19. Approximately two weeks after recovering, the hives are back. It would seem the Moderna booster triggered an allergic reaction to covid antibodies. I now have to rely on allergy pills to simply live comfortably. Additionally, it has lead to breast and armpit pain/discomfort that comes alongside the hives and is relieved only by antihistamines.
bitter taste; dry mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (bitter taste) and DRY MOUTH (dry mouth) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced DYSGEUSIA (bitter taste) and DRY MOUTH (dry mouth). At the time of the report, DYSGEUSIA (bitter taste) and DRY MOUTH (dry mouth) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There were no concomitant medications provided.   Patient has been using mouthwash to treat her symptoms, but it doesn't do anything.
Per Family, developed a very high fever and abdominal pain, went to ER.  Was told that this was a known complication of Hepatitis A vaccination.  However, our inventory audit revealed that she had been given a Haemophilus vaccination by mistake.  I found out about the ER visit when I called Mom to tell her about the med error.
I had a swollen lymph node in my right armpit. It has been there since the second week after my vaccination. The size fluctuates. I started taking amoxycillin on December 6, 2022. I took it for seven days. It got smaller, but it's still there.
Patient came in and asked to receive the Janssen vaccine. She completed her consent form and answered "no" to the question asking if she has received a COVID-19 vaccine.The patient was given the Janssen vaccine but had already received both Pfizer vaccines.
Delayed hypersensitivity reaction- arm rash in area of vaccination that appeared a week after administration and took a few days to go away
This literature-non-study case was reported in a literature article and describes the occurrence of VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.      No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced MYALGIA (flulike muscle aches). On 19-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (tested postive for SARS-CoV-2 RNA). On an unknown date, the patient experienced VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) (seriousness criterion medically significant). On 20-Feb-2021, MYALGIA (flulike muscle aches) had resolved. At the time of the report, VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) and COVID-19 (tested postive for SARS-CoV-2 RNA) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient's symptoms included oropharyngeal pain, nasal congestion, anosmia and headache.  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the event (myalgia) a causal relationship cannot be excluded. Based on the mechanism of action of mRNA-1273, the event (Covid-19) is assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event (myalgia) a causal relationship cannot be excluded. Based on the mechanism of action of mRNA-1273, the event (Covid-19) is assessed as unlikely related to mRNA-1273.
Injection site pain  Fever Nausea  Diarrhea  Body aches  Mild asthma symptoms
Within 72 hours of shot, diagnosed @ ER with  left pulmonary embolism. No previous history.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021 at 3:47 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Patient's were given doses from vials that were stored in an ultracold freezer which was colder than they should have been. Unknown that the patient had COVID-19 and Allergies Treatment information was not provided
High fever, vomiting, muscle pain, cellulitis-like rash around injection site, severe arm pain in injected arm.
1st dose on 9/10/ 2019, 2nd dose last week; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10th September 2019).   On 5th January 2022, the patient received the 2nd dose of Shingrix. On 5th January 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix late than the recommended time interval, which led to lengthening of vaccination schedule. The reporter was in a rush so she did not have patient and vaccine´s details at the moment of the call. The reporter consented to follow up.
My mom received the first Pfizer dose and unexpectedly went into sudden cardiac arrest and died  one week and a half later. She had no known prior Comorbidities. Her death came as a total shock to us all
light diarrhea for 8 weeks; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (light diarrhea for 8 weeks) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 043B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included COLECALCIFEROL (VITAMIN D3) and MELATONIN for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced DIARRHOEA (light diarrhea for 8 weeks). The patient was treated with BIFIDOBACTERIUM INFANTIS (ALIGN) at a dose of 1 dosage form; LACTOBACILLUS RHAMNOSUS (CULTURELLE DIGESTIVE DAILY PROBIOTIC CHEWABLES) at a dose of 1 dosage form and VITAMIN C [ASCORBIC ACID] at a dose of 1 dosage form. At the time of the report, DIARRHOEA (light diarrhea for 8 weeks) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: unknown (Inconclusive) unknown. On an unknown date, Ultrasound abdomen: unknown (Inconclusive) unknown. On an unknown date, X-ray: unknown (Inconclusive) unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Align Culturelle with vitamin C is used as treatment
Chills, fever, muscle aches (back and chest), cough, and fatigue.
Vaccine administered after improper storage & handling; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Oct-2021 and was forwarded to Moderna on 06-Oct-2021.    This spontaneous case was reported by a medical assistant and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered after improper storage & handling) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after improper storage & handling). At the time of the report, PRODUCT STORAGE ERROR (Vaccine administered after improper storage & handling) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided  No treatment medications were provided.