chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a other health professional refers to a 12 week old patient who on 19-FEB-2014, was vaccinated with a 2.0 ml dose of ROTATEQ oral (lot number H012252) that was expired. The vaccine expired on 29-JAN-2014. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Administration of the adjuvant only; Administration of the adjuvant only; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 14-Sep-2022 Reporter's comment: The pharmacist reported that the patient was administered with the adjuvant of Shingrix without prior reconstitution.  The pharmacist did not provide any other information. The reporter consent to follow up. Additional Supportive Information: The patient was administered with the adjuvant of Shingrix without prior reconstitution, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Hives developed while eating, about 3 to 3 1/2 hrs after vaccine administered. No respiratory changes or swelling. Administration site ok. Improved with antihistamine. Pt w/ongoing intermittent hives prior to vaccine.
Patient has a history of asthma and felt like her chest was tight and difficult to breathe. She used inhaler and nebulizer without relief.
Had mild shortness of breath; Annoying cough that sounded like bronchitis cough; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Had mild shortness of breath) and COUGH (Annoying cough that sounded like bronchitis cough) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included Flu vaccination (Over 20 years ago she had mild reaction to a flu vaccine; mid tingling of lip and tongue and rapid heart beat).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DYSPNOEA (Had mild shortness of breath) and COUGH (Annoying cough that sounded like bronchitis cough). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) ongoing since an unknown date at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for  and COVID-19 vaccination, at a dose of 25mg an hour before the vaccine. On 04-Mar-2021, DYSPNOEA (Had mild shortness of breath) and COUGH (Annoying cough that sounded like bronchitis cough) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Chest X-ray: normal (normal) normal. On 02-Mar-2021, SARS-CoV-2 test negative: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication information was available. Patient was prescribed an Inhaler.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Contact details updated On 09-Jul-2021: Non-Significant follow up
ERROR only, No ADR, given 5 days too early Narrative:  Too early ERROR, no ADR.
This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Had flu-like feeling the next day), VACCINATION SITE PAIN (Pain in her arm (injection site)) and MYALGIA (Was Achy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. No medical history was provided by the reporter. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Had flu-like feeling the next day), VACCINATION SITE PAIN (Pain in her arm (injection site)) and MYALGIA (Was Achy). At the time of the report, INFLUENZA LIKE ILLNESS (Had flu-like feeling the next day), VACCINATION SITE PAIN (Pain in her arm (injection site)) and MYALGIA (Was Achy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. No treatment information provided.
Headache, Myalgia, SkinRash, arm pain Narrative:  Initial dose in December 2020 resulted in arm pain x several days. Within 2 hours of 2nd dose on 1/20/21 developed sore arm which lasted 48 hours. At 1700 on 1/20/21 developed rash on chest (described heat rash, no hives) x 1-2 hours. On 1/21/21 noted severe headache and body aches. Missed work 1/21/21. Symptoms improved afternoon of 1/21/21.  Other Relevant History:
DOSE WAS GIVEN FROM PREVIOUSLY PUNCTURED VIAL STORED IN THE REFRIGERATOR FOR OVER 24 HOURS; This spontaneous report received from a pharmacist concerned multiple patients.  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: 182128B, and batch number: 182128B expiry: 06-SEP-2021) dose was not reported, administered on 29-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUN-2021, the subject experienced dose was given from previously punctured vial stored in the refrigerator for over 24 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dose was given from previously punctured vial stored in the refrigerator for over 24 hours was not reported. This report was non-serious.
HOSPITALIZATION RELATED TO COVID 19 FOLLOWING COMPLETION OF PRIMARY VACCINE SERIES.
She had a very severe headache.  Took two extra strenth Excedrin for migraine.  It didn't help.  Pain level 9.  Almost took her to emergency room.
Very mild reactions; The lymph node on injection site arm is painful; I developed a 5 by 2 inch red oval blot at the injection site; The injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Very mild reactions), LYMPH NODE PAIN (The lymph node on injection site arm is painful), VACCINATION SITE ERYTHEMA (I developed a 5 by 2 inch red oval blot at the injection site) and VACCINATION SITE PRURITUS (The injection site) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced LYMPH NODE PAIN (The lymph node on injection site arm is painful), VACCINATION SITE ERYTHEMA (I developed a 5 by 2 inch red oval blot at the injection site) and VACCINATION SITE PRURITUS (The injection site). On an unknown date, the patient experienced VACCINATION COMPLICATION (Very mild reactions). At the time of the report, VACCINATION COMPLICATION (Very mild reactions) outcome was unknown and LYMPH NODE PAIN (The lymph node on injection site arm is painful), VACCINATION SITE ERYTHEMA (I developed a 5 by 2 inch red oval blot at the injection site) and VACCINATION SITE PRURITUS (The injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medicines was not reported by reporter  treatment information was not provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments   Most recent FOLLOW-UP information incorporated above includes: On 12-Feb-2021: fallow up received on 12-feb-2021 contains one new event was added
BOOSTER (THIRD) DOSE GIVEN TO PATIENT UNDER AGE OF 18 YEARS.
Hospitalized for four days on Sept 9, starting having shortness of breath next day and ER Myocarditis and Pericarditis.
he experiences a lot of pain due to his bone cancer/been worse recently/pain has increased; more tired/tiredness; more headaches/headache; slight nausea/light nausea that is not very severe; feels very sick/not feeling well; muscle pain; joint pain; injection site swelling and redness; injection site swelling and redness; swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Mar2021 (at the age of 63 years old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation.  Medical history included ongoing bone cancer, ongoing pain from bone cancer, and nausea (has had nausea with the cancer). The patient's concomitant medications were not reported. The patient called about COVID-19 vaccine and mentioned that he received the 1st dose of COVID-19 vaccine on 25Mar2021 and experienced side effects not right away but shortly thereafter. He mentioned that he has bone cancer and he experience a lot of pain due to his bone cancer. He does not have an easy life as he experiences a lot of pain due to his bone cancer. He has a lot of pain to begin with because of the cancer that he has and now pain has been worse recently.  He does not know if it just the progression of the pain or if it is coming from the injection.  The patient confirmed that he experienced lists of side effects of more tired/tiredness, more headaches/headache, muscle pain, joint pain, injection site swelling and redness, slight nausea, feeling unwell, and swollen lymph nodes. He still feels very sick, is in a lot of pain, and not feeling well. He confirmed this list is from the paperwork he was given and adds that the only thing that he feels is light nausea that is not very severe.  He added that he has had nausea with the cancer, so this nausea would be very light.  But, he also he has a headache and tiredness. The patient added that his pain has increased, and the pain is the worst. The patient did not know how long it will take before feeling side effects from the vaccine or how that works.  The patient asked if the side effects is same for everyone or if it is different for everybody. He added that reporting the event is not going to help in finding out where he is going with this.  He stated he is at a crossroads, trying to determine if he needs to increase his pain medication since he now has more pain. He understands that Pfizer does not provide medical advice.  He states that he was asking Pfizer to see if Pfizer has an understanding of when these side effects might show themselves or when they would and how severe they would come. His second vaccination is due on 15Apr2021. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Numbness in legs, arms and abdomen, progressed over 72 hours, took her back to the hospital and she has been diagnosed with Guillain-Barre Syndrome. She is still in the hospital.  11/3/2009 Hospital records received service dates 10/23/09 to 10/24/09 and 10/28/09 to 11/3/09. Assessment: Peptic ulcer disease.  Neurological Assessment: Consider GBS, sarcoid, syphilis, HIV, Lyme, viral meningitis.  Patient presented with onset of abdominal pain 5 days prior to admission. Throbbing sensation in epigastric region. Anorexic. Bronchitis. Given pain meds and azithromycin at ED, developed rash, fevers, chills, headache, sore throat. Bloated, flatus decreased. Presents later with numbness and weakness in feet. Bottoms of feet hurt, pins and needles, has progressed to buttocks. Fihgers tips and arms are numb. Wide stance, unable to walk. Diffuse weakness. Obese. Anxious. Cough. IVIG administered. Lower extremety edema. Feeling better - to be discharged.  11/12/09 Two hospital DC summaries received.   Infection Diseases - service dates 10/23/09 to 10/24/09. Assessment: Peptic ulcer disease. Allergy to Azythromycin.  Neurology - service dates 10/28/09 to 11/03/09. Assessment: Suspected Guillain-Barre Syndrome.  11/19/09 DC summary and hospital records received for service dates 10/25/09 to 11/3/09. Additional information abstracted.  Discharged using walker.
3:00 pm, pt felt extremely fatigued; 6:00 pm, started coughing & at 6:30 pm, more frequently coughing & general malaise. Went to bed 7:00 pm, eyes very itchy, red & swollen. 8:00 pm, eye sockets very tender to touch & eyes still swelling.
Patient admitted 11/7/11 and discharge 11/8/11 readmitted 11/10/11 and discharged 11/14/11 from hospital for partial bowel obstruction.  Final discharge diagnosis was dehydration after Hirschsprung's Enterocolitis which responded to IV ampicillin/gentamicin and metronidazole.  Patient had completed 3rd dose of RotaTeq on 4/19/11.  AE was not related to vaccination.  Rotavirus ag in stool negative twice.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A male child patient of an unspecified age and ethnicity received a single dose of TRUMENBA, via an unspecified route of administration, on an unspecified date. The patient medical history and concomitant medications were not reported. Upon vaccination, on an unspecified date, the patient fainted and his arms moved uncontrollably (as if having seizure), furthermore the day after the vaccination he presented fever of 102 degrees F. Outcome of events was unknown at the time of this report. No follow-up attempts are possible. No further information is expected.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 3:01 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 22.89.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15- Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
devel varicella rash 10 days p/vax;>50 lesions, generalized rash & scabbed over p/5 days;no new crops appeared, afeb;
This spontaneous report was received from a licensed nurse practitioner refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-AUG-2015, the patient was vaccinated with expired dose of PROQUAD (Merck), lot # J014237, expiry date 07-MAY-2015, subcutaneously. It was unspecified by the reporting nurse if this was the first or second dose of PROQUAD (Merck) that the patient had been administered. No adverse effect reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of two reports received from the same reporter. Additional information has been requested.
patient started feeling bad in the evening. wife states she thinks he was vaccinated around 11am on 12/27. he started running a fever around 10 or 11pm. over night he progressed and got worse. patient needed to get up and use the restroom and was so weak he could not stand. took him to the er on 12/28. they gave him fluids and an antibiotic. wife states they did all sorts of blood work and checked for uti. nothing came back abnormal and they told her he had just had a severe reaction to the vaccine and to call pharmacy and have them report it. speaking to wife today, 12/29, patient is much better but still a little weak.
Patient (11 years old) mistakenly received the adult dose of the Pfizer COVID vaccine.  No actual adverse events occurred; submitting VAERS report given requirements to report when COVID vaccine administration errors occur.
lost sense of smell; This is a spontaneous report from a contactable consumer or other non hcp via Pfizer Sponsored Program . A male patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date patient experienced lost sense of smell. It was reported that no patient identifiers were provided- it was unknown if the reporter had a specific patient in mind. Swap from  Pharmacy with patient who lost sense of smell just hours after receiving first CoVax dose. Asked if there was any information on that. The outcome of the event was unknown.  No follow-up attempts are required. Information about lot/batch number cannot be obtained. No further information is expected.   .
first was fever 100.9 and chills. injection site was sore and soon left elbow area was aching. ftemp stayed at 100.9 during the night along with a headache  and sleep was restless. by morning temp had lowered to 99.9 and some of the body aches were dissapating.. after several more hours the temp has returned to normal and all that is left is a headache. total time of issues was  about 17 hours.
Administer expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.   Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 168 doses. The vial did not undergo any temperature excursions.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains non significant information.
.  Low grade fever. Extreme fatigue. Stomach cramps. Vomit. Body aches. Headache. Lasted more than 24 hours. Took advil for fever. Sleep. Fasted for 36 hours. Fever broke. Fatigue reducing. Pain redness in shot arm.
This is a continuation of a report I started that "timed out".   Oximeter levels of 93-94 and pulse of 40-50 for two days. If my cat hadn't jumped on my chest, I probably would be dead right now. In 1997,  I suffered cardiac arrest after hypoxia  of unknown cause (mowing the lawn). At that time, I drove 5 miles to a friend's house with no detectable pulse. I arrested in the ambulance on the way to the hospital, and tests could not find a cause.  After reading about COVID vaccine, it is my understanding the vaccine works by releasing MAST cells.  I can only conclude that I suffered hypoxia from the release of MAST cells, following this vaccination. I've been getting regular flu shots for 25 years, and never had this happen before.
Dose administered after 30-day Use By Date; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date).    Concomitant products were not reported.  It was reported that vial size was 2.5ml, 1 vial (1 dose) was used and the vial was initially stored in the refrigerator on 10-Dec-2022. The vial did not undergo any temperature excursions. HCP does not have the patient information.  Treatment medications were not reported.
Headache started about 4:30pm. Developed fever overnight. Woke up next morning with lightheadedness and fatigue. Symptoms resolved by 12:00pm.