chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SkinRash, Rash,  rash to chest, head, abdomen, scratchy throat  Narrative:
active covid infection; Soreness of arm at injection site; Joint pains; Fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (active covid infection) in a 37-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 08-Apr-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 COVID-19 (active covid infection) (seriousness criterion medically significant), VACCINATION SITE PAIN (Soreness of arm at injection site), ARTHRALGIA (Joint pains) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COVID-19 (active covid infection), VACCINATION SITE PAIN (Soreness of arm at injection site), ARTHRALGIA (Joint pains) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Additional Information received included no new significant information.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. However, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable.
This spontaneous report as received from a register nurse refers to a 2 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 21-FEB-2014, the patient was vaccinated with dose 1 of ROTATEQ, lot #J007283; expiration date: 27-SEP-2014 (dose and strength were not reported. Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Patient scheduled to receive 2nd dose (MONOVALENT) to complete series. However, patient received bivalent vaccine as second dose.
This spontaneous report was received from a nurse concerning to a 7 month old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 08-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength and dose were unspecified), the route was defaulted to oral. No concurrent medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 54-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; HEADACHE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "body aches". Additional information: It was reported that the patient's weight was 150. The event took place after use of product. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Symptoms for 4 days - nasal congestion, drainage, tickle in throat. no fevers or chills. Productive cough, no wheezing or shortness of breath. Thera flu not really helpful. Significant pain and discomfort with cough due to his recent surgery. He quit smoking about after his CABG 8 weeks.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. Pharmacist reported that on 02-JAN-2018, the patient was vaccinated with VARIVAX (lot # N019839, expiration date 17-JUL-2019) (dose and frequency were not reported) reconstituted with sterile diluent (lot # and expiration date were not provided) by the intramuscular route rather than subcutaneous route. There was no adverse effect reported. No further information provided.
Indicate at which point in the process the medication error ocurred: Storage in clinical practice; No adverse reaction; HCP reports that a patient was given an expired dose of VAQTA; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-APR-2023, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, administered for prophylaxis (strength, dosage, vaccination scheme, route of administration, anatomical site of injection, lot number, and expiration date were not reported) (expired product administered ). No additional adverse events were reported.  This case was classified as non-valid due to the lack of patient's identifiers.  Follow-up information was received from a pharmacist on 17-APR-2023.  The report concerns to 26-year-old patient.  The vaccine was administered via intramuscularly, the expiration date was reported as 30-MAR-2023.  It was reported that no adverse reaction occured and that medication error happened in the storage clinical practice (product storage error).
high fever for 5-6 hours; chills for 5-6 hours; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high fever for 5-6 hours) and CHILLS (chills for 5-6 hours) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027621A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (high fever for 5-6 hours) and CHILLS (chills for 5-6 hours). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, PYREXIA (high fever for 5-6 hours) and CHILLS (chills for 5-6 hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2022, Body temperature: 99.1 (High) 99.1 F.         Patient reported he was on concomitant medication, but did not specify which ones.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL 9 injection (exact dose and route unknown) lot # M013636, expiry date 15-FEB-2018 for prophylaxis. The vaccine was stored between 47 degrees Fahrenheit (F) to 77F for 40 hours. No previous temperature excursions were detected. Data logger was involved. No adverse effects reported.
This spontaneous report was received from a pharmacist and refers to a 64 year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 03-JUL-2017, the patient was vaccinated with ZOSTAVAX, lot # N009167 and expiration date 02-FEB-2018, (dose, route and anatomical location were not reported), for prophylaxis. No other suspect or concomitant therapies were reported. On an unknown date in 2017, the patient developed a red raised and warm to touch "area" at the injection site. The patient was treated with BENADRYL and with "cold compresses". At the time of reporting, the outcome of injection site erythema, injection site reaction and injection site warmth was unknown, and, the reporter did not assess the causal relationship between the injection site erythema, injection site reaction and injection site warmth with ZOSTAVAX.
3/26 nose bleed (lasting 5 minutes) and exhaustion - feeling unwell 3/27 headache, exhaustion, nausea, fever chills - feeling unwell 3/28 exhaustion and nausea - feeling unwell 3/29 night sweats, headache, nose bleed lasting 20 minutes - feeling unwell 3/30  - feeling unwell
Sore legs, sore feet, sore hips and buttox.  Fatigue.  This has been ongoing for more than a week. It persists still, today.
Soreness at the injection site; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), intramuscular on the left arm on 18Dec2020 13:00 at a single dose for covid-19 immunization. The patient's medical history included hypertension (HTN) and elevated triglycerides. The patient was not pregnant. The patient have no allergies to medications, food, or other products. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included metoprolol and fenofibric acid. The patient experienced soreness at the injection site on 19Dec2020 05:00. No treatment was received for the adverse event. Outcome of the event was recovered on Dec2020.
Began with localized swelling and pain at injection site. This became generalized fatigue before bed. The following day, my body felt like i had developed the flu, body aches, fatigue, soreness at injection site, headaches. These symptoms progressed and lasted in total 6 days. During that time my capacity to work was severely diminished (had to take off work). I felt fatigue on exertion.
Chills, fever, full body muscle aches, diarrhea, nausea, headache, sore throat, ear pain
red mark on her cheek; face was flush; rapid heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red mark on her cheek), FLUSHING (face was flush) and TACHYCARDIA (rapid heartbeat) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced ERYTHEMA (red mark on her cheek), FLUSHING (face was flush) and TACHYCARDIA (rapid heartbeat). At the time of the report, ERYTHEMA (red mark on her cheek), FLUSHING (face was flush) and TACHYCARDIA (rapid heartbeat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that her PEG test was negative and physician wanted her to take antihistaminic medication before the second dose.
34y/o came into our walk-in clinic on Friday August 27th requesting Janssen.  He informed the Nurse Screener that this was his first dose of Covid-19 vaccine and answered ?no? to question #4 if he had ever received a covid vaccine before.   He also told that he wanted the 1 dose covid vaccine, he didn?t have a previous covid card, and had no other concerns.  As the RN was completing documentation 2 hours later she noted he received Moderna on 06AUG2021.  RN attempted to reach patient, without any answer to phone.
After received PREVNAR shot fr pharmacy, patient became sick, and went in hospital. Hospital dr discovered patient had Strep infection in blood stream with no injection site reaction, started Doxycycline Drip as antibiotic treatment. Last 2 weeks patient had once a day tx daily as out patient status. Patient recovered show stable and fine when he reported to pharmacy on 12/30/2017. 1/5/2018 dr finished this tx w no bacterias in blood and ordeered recheck in 2 week for another culture.
Pt developed fever, rash, running nose, and cough during the nigh after receiving the 4 month series.
This spontaneous report was received from a medical assistant (clinical coordinator) and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On an unknown date in 2017, between 27-JUL-2017 and 03-AUG-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot # reported as N008077; expiration date: 09-MAR-2019; dose and route of administration were not reported). Concomitant therapy included properly stored sterile diluent (MERCK) injection. The reporter stated that the administered dose of VARIVAX was stored at temperature of -10.7 degrees Celsius for 2 hours 10 minutes. Data logger was used to detect temperature excursions. There were no previous temperature excursions reported. No adverse effects were reported. No product quality complaint was involved. This is one of seven reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA005837: US-009507513-1708USA005841: US-009507513-1708USA005839: US-009507513-1708USA005840: US-009507513-1708USA003358: US-009507513-1708USA005838.
Ankylosing spondylitis; Colitis ulcerative aggravated; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4462705-00 (Company Pharmacovigilance).  A 42-year-old male patient received BNT162b2 (BNT162B2), as dose numner unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk, citrate free, subcutaneous for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANKYLOSING SPONDYLITIS (medically significant), outcome "unknown"; COLITIS ULCERATIVE (medically significant), outcome "unknown", described as "Colitis ulcerative aggravated". The action taken for adalimumab was unknown.  The reporter considered "ankylosing spondylitis" and "colitis ulcerative aggravated" related to BNT162b2.  Clinical course: The reporter's causality for the event(s) of ANKYLOSING SPONDYLITIS and ULCERATIVE COLITIS FLARE UP IN BACK was not provided for HUMIRA(ADALIMUMAB). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Patient had the following symptoms - Chills, soreness, nausea, vomiting. Joint Pain. Called him MD and was informed of a possible allergy reaction. Symptoms went away in 2 days.
Several hours after vaccine was administered, pt developed a red indurated rectangular area that was tender to touch at the site of the injection.  Patient called office and MD instructed her to watch for worsening factors (i.e. fever), use Benadryl prn, Hydrocortisone cream prn, and ice.  Instructed pt that symptoms should subside in a few days and that it is most likely an allergic reaction and not to get the pneumovax in the future.
Diminished lung capacity with SOB and slight cough upon exhalations, intermittent. Started day of vaccination and continues.
Reaction to the vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION COMPLICATION (Reaction to the vaccine) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction to the vaccine). At the time of the report, VACCINATION COMPLICATION (Reaction to the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported.  No treatment medication were reported.
Patient stated that he needed his covid booster. prepared and administered dose. Upon documentation into covid vaccine database the interval between patient's previous dose and this dose was noted to be too short.  was informed and she promptly discussed with the provider. telephoned the patient to inform him and address any questions or concerns he had. Patient denied concerns.
NauseaVomiting chills, epigastric pain Narrative: Per nursing report: " report adverse side effects after taking her 2nd dose of Moderna vaccine on 9/8/21. Employee report symptoms of  chills, stomach pain and nausea since this morning 09/29/21."
Redness all the way around the arm on the first day and on the second day the redness had swelled somewhat.  Patient took benadryl and ibuprofen.
Hospitalization for severe sepsis/ acute perforated diverticulitis, hypokalemia (COVID positive test two days into admission)  on dates 8/25/2023- 8/29/2023. Treated with vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Pertinent medical history, drug reaction or allergies were not reported. On 21-OCT-2014 the patient was inadvertently vaccinated with an expired dose of M-M-R II, lot # H018945, expiration date 18-OCT-2014, (dose, dose number, route and anatomical location were unspecified). No adverse effect reported. No concomitant therapies were reported. The outcome of the events was unknown. Additional information has been requested.
This spontaneous report was received from a health care worker referring to an unspecified number of patients of unknown ages and genders. Information regarding medical history or concurrent conditions was not informed. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (which had the lot # L040181, expiration date 18-AUG-2017, L035686, expiration date 16-FEB-2017) (dose, route and anatomical site of vaccination were not provided). Information regarding concomitant medication was not reported. No adverse effects were reported. There was not product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
FEELING OF ALMOST PASSING OUT; ROEMHELD SYNDROME; ANHEDONIA; WEIGHT LOSS AROUND 10 POUNDS/ LOST 40 POUNDS; SEVERE GAS; DIARRHEA; LIGHT ASTHMA; This spontaneous report received from a patient concerned a 36 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included childhood asthma, caffeine allergy, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with prednisone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced light asthma. On 29-MAR-2021, the subject experienced anhedonia. On 29-MAR-2021, the subject experienced weight loss around 10 pounds/ lost 40 pounds. On 29-MAR-2021, the subject experienced severe gas. On 29-MAR-2021, the subject experienced diarrhea. On 18-MAY-2021, the subject experienced roemheld syndrome. On an unspecified date, the subject experienced feeling of almost passing out. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not reported, Cardiovascular evaluation (NR: not provided) Not reported, Helicobacter pylori infection (NR: not provided) Negative, and Psychiatric evaluation (NR: not provided) Not reported. Treatment medications (dates unspecified) included: macrogol 3350, and omeprazole. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anhedonia on 05-APR-2021, and light asthma on 25-MAR-2021, had not recovered from diarrhea, roemheld syndrome, severe gas, and weight loss around 10 pounds/ lost 40 pounds, and the outcome of feeling of almost passing out was not reported. This report was non-serious.
Pain developed from the injection site to the pt's elbow the following day. Md dx pt with shingles on 9/25/2017.