chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-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 COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
Patient recived expired Moderna Covid-19 vaccine; Patient recived expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Patient recived expired Moderna Covid-19 vaccine) and EXPIRED PRODUCT ADMINISTERED (Patient recived expired Moderna Covid-19 vaccine) in an 81-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced PRODUCT STORAGE ERROR (Patient recived expired Moderna Covid-19 vaccine) and EXPIRED PRODUCT ADMINISTERED (Patient recived expired Moderna Covid-19 vaccine). At the time of the report, PRODUCT STORAGE ERROR (Patient recived expired Moderna Covid-19 vaccine) and EXPIRED PRODUCT ADMINISTERED (Patient recived expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown. Date the vial was initially stored in the refrigerator: 31-Mar-2022.
Incorrect vaccine -  Ages 12 years and older (purple cap) Pfizer administered to patient under the age of 12.
Patient received 0.5ml dose as a Booster rather than 0.25ml.
I'm having an extremely painful menstrual period that is new and unusual for me. The pain is impeding my normal daily activities to the point that I am not able to function as I normally would. I also have increased fatigue and impaired focus. It literally hurts for me to stand up. This is my 1st period after my 2nd dose. I had no issues of this nature after my 1st dose.
The site is not itchy now but when it was in the past; Noticed a red area that looks like bug bite at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Noticed a red area that looks like bug bite at the site of injection) and VACCINATION SITE PRURITUS (The site is not itchy now but when it was in the past) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L29A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Noticed a red area that looks like bug bite at the site of injection). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (The site is not itchy now but when it was in the past). At the time of the report, VACCINATION SITE ERYTHEMA (Noticed a red area that looks like bug bite at the site of injection) had not resolved and VACCINATION SITE PRURITUS (The site is not itchy now but when it was in the past) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Disruption in menstrual cycle/ very delayed cycle; Unusual cramps; This is a spontaneous report from a contactable healthcare professional, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via intramuscular route of administration on 26Jul2021 at 10:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Jul2021, directly after first vaccination, the patient experienced disruption in menstrual cycle, very delayed cycle with unusual cramps. Since the vaccination, the patient had been tested for COVID-19. On 23Aug2021, the patient underwent COVID-19 test and the result was negative. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events disruption in menstrual cycle/ very delayed cycle and unusual cramps were not resolved at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0T65) via unspecified route of administration in the right arm on an unspecified date in 2021 (at the age of 36-year-old) as a single dose for COVID-19 immunisation.
Tinnitus- since vaccine I?ve have a constant ringing in my ears , hard to fall asleep and then have nighttime awakenings. Shortness of breath, chest pain, tingling of my left side of the face , fatigue.
sick after the shot; sore arm; headache; nausea for a day or two; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick after the shot), PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and NAUSEA (nausea for a day or two) 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 ILLNESS (sick after the shot), PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and NAUSEA (nausea for a day or two). At the time of the report, ILLNESS (sick after the shot), PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) outcome was unknown and NAUSEA (nausea for a day or two) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment information was reported. It was reported that the reporter's co-workers that got either Moderna or Pfizer and experienced symptoms.
Vaccine that administered beyond use date after the thaw process; 2nd dose received 0.25ml instead of 0.5ml; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) and UNDERDOSE (2nd dose received 0.25ml instead of 0.5ml) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) and UNDERDOSE (2nd dose received 0.25ml instead of 0.5ml). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) and UNDERDOSE (2nd dose received 0.25ml instead of 0.5ml) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported  It was reported that no adverse reactions to patient after the administration of vaccine.  Vaccine number 1 NDC code was reported as 80777-0273-99. No treatment medications were reported
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 54 year male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration not reported, batch number: 211A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered at left arm on 05-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-DEC-2021, patient has been testing negative Saturday and Sunday with the rapid test since he was exposed to his wife who tested positive on Saturday 25-DEC-2021. Laboratory data included: SARS-CoV-2 rapid diagnostic test (NR: not provided) Negative. On 26-DEC-2021, Laboratory data included: SARS-CoV-2 rapid diagnostic test (NR: not provided) Negative. On 27-DEC-2021, the patient tested positive with a rapid home kit test for COVID-19 (suspected clinical vaccination failure, and suspected covid-19 infection), patient reports a little bit of joint and muscle fatigue and some tightness in chest and reports being relatively well. Laboratory data included: SARS-CoV-2 rapid diagnostic test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211258883-COVID-19 VACCINE AD26.COV2.S- suspected covid-19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211258883-COVID-19 VACCINE AD26.COV2.S- suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Swelling in face, lips and tounge with dizzy spells. Patient has received a shot at 11am on 07/28/2018 and ended at emeregency rrom around 3pm on the same day. Followed up with a patient on 7/30/2018. He stated that he stills feels tired.
Felt strange after second Moderna COVID-19 vaccine; Felt tired after second Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt strange after second Moderna COVID-19 vaccine) and FATIGUE (Felt tired after second Moderna COVID-19 vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced FEELING ABNORMAL (Felt strange after second Moderna COVID-19 vaccine) and FATIGUE (Felt tired after second Moderna COVID-19 vaccine). At the time of the report, FEELING ABNORMAL (Felt strange after second Moderna COVID-19 vaccine) and FATIGUE (Felt tired after second Moderna COVID-19 vaccine) outcome was unknown.            Patient received Moderna vaccine at Health Department. No concomitant medication was provided. No treatment medication was provided. Patient received first Moderna Covid-19 vaccine on 15JAN2021 and had not experienced any adverse reactions to report.
This spontaneous report as received from an immunization program refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of improperly stored PNEUMOVAX23 (lot # J006921, expiration date: 09-AUG-2014 (dose and route not reported. Additional information is not expected.
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown gender and age. Information regarding the patients' medical history, concurrent conditions and concomitant medications were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot# N000682, expiry date: 06-JAN-2019, lot# M040138, expiry date: 28-SEP-2018 and lot# M010484, expiry date: 01-MAR-2018) for prophylaxis. Nurse reported that the vaccine underwent a temperature exposure at -14 to -10 degrees Celsius, for 3 hours and 9 minutes. There were not previous temperature excursions. Data logger was involved. No adverse effects were reported. This is one of the two reports received from the same reporter (MARRS# 1707USA009377). Additional information has been requested.; Sender's Comments: US-009507513-1707USA009377:
7:30- 8:00 pm started having 100.9 fever; body aches; joint pain that continued throughout the night. Saturday morning - fever down to 99.9; joint pain and body aches still there. Yesterday (the31st) I had low grade fever in the morning - 99.3 and some body aches and I took Tylenol (started taking this yesterday, 31st). Today, Feb 1, 2021, I have swelling and redness in my arm. Not right on the vaccine site - it's a bit lower and it's warm at touch. It hurts where the redness where it feels hot (not at the vaccine site). I am still using the arm but it does hurt to try to lift it.  The body aches and joint pain have gone and I haven't felt like I have a fever today.
Does not feel good; Stomach problems and is a mess today; This spontaneous case was reported by a consumer and describes the occurrence of GASTRIC DISORDER (Stomach problems and is a mess today) and MALAISE (Does not feel good) in a 53-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 AMLODIPINE for an unknown indication.    On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced GASTRIC DISORDER (Stomach problems and is a mess today). On 26-Apr-2021, the patient experienced MALAISE (Does not feel good). At the time of the report, GASTRIC DISORDER (Stomach problems and is a mess today) and MALAISE (Does not feel good) outcome was unknown. Not Provided          Treatment details included Gasex and Pepto bismol.  Action taken with mRNA-1273 in response to the events was not applicable.
Patient was noted to have abrupt respiratory failure 2 days after taking the 1st dose. The patient was admitted to the hospital for acute respiratory failure with hypoxemia secondary to acute CHF exacerbation. The patient had a transthoracic echocardiogram performed 2 weeks prior to hospitalization that was noted to show a left ventricular ejection fraction of 60-65%. At the hospitalization, her left ventricular ejection fraction was noted to decrease to 25-30%. Left heart catheterization was performed and showed no signs of ischemic heart disease (coronary artery disease). Patient was started on Entresto 24/26mg PO BID and Toprol XL 50mg PO daily and was diuresed with Bumex 1mg IV daily and was noted to have improvement in respiratory symptoms for which she was weaned off of BiPAP 15/5 with FiO2 of 50% down to room air. Patient had repeat transthoracic echocardiogram ordered prior to discharge and was noted to have an improvement in left ventricular ejection fraction to 48% prior to discharge. The only change was that the patient had the COVID-19 vaccination. Patient does not have any history of coronary artery disease or heart failure. Patient was worked up extensively for other etiologies of heart failure and none were found.
rash on chest and back; headache; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on chest and back) and HEADACHE (headache) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2022 at 12:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (headache). On 10-Jan-2022, the patient experienced RASH (rash on chest and back). At the time of the report, RASH (rash on chest and back) and HEADACHE (headache) outcome was unknown.            Concomitant medications were not reported. Treatment medications were not reported. Rash on chest and back  started  around noon.   This case was linked to MOD-2022-447768, MOD-2022-449895, MOD-2022-449902 (Patient Link).
Pt vaccinated with DTP/OPV/HIB/MMR broke out in big splotches all over & was having a little trouble breathing. Advised to take child to ER where she was treated w/Benadryl & Epinephrine Given Pediapred & Benadryl PO on discharge.
numbness in her fingers; numbness in her cheeks; weak; sore throat; exhausted; headache; muscle pain; some nausea; fever of 101.5; severe chills; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in her fingers), HYPOAESTHESIA (numbness in her cheeks), FATIGUE (exhausted), ASTHENIA (weak) and HEADACHE (headache) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced HYPOAESTHESIA (numbness in her fingers), HYPOAESTHESIA (numbness in her cheeks), FATIGUE (exhausted), ASTHENIA (weak), HEADACHE (headache), OROPHARYNGEAL PAIN (sore throat), MYALGIA (muscle pain), NAUSEA (some nausea), PYREXIA (fever of 101.5), CHILLS (severe chills) and VACCINATION SITE PAIN (pain at the injection site). At the time of the report, HYPOAESTHESIA (numbness in her fingers), HYPOAESTHESIA (numbness in her cheeks), FATIGUE (exhausted), ASTHENIA (weak), HEADACHE (headache), OROPHARYNGEAL PAIN (sore throat), MYALGIA (muscle pain), NAUSEA (some nausea), PYREXIA (fever of 101.5), CHILLS (severe chills) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.5 (High) 101.5.         Concomitant medication was not reported. Treatment medication was not reported. The patient had vaccination at 08:40 AM and experienced the events at 08:50 AM on 21-Jan-2021.
Evening of vaccine admin.  Severe pain to entire left arm and marked general malaise, decreased ROM, chills, afebrile, insomnia, aches.
Fatigue, headache, chills, gastrointestinal discomfort/pain (particularly upper stomach area). Took Tylenol (2x 500 mg) and rested by lying down and sleeping for most of the day. Felt recovered about 22 hours after symptom onset.
itching at site; redness at injection site; swelling at injection site; chills; fever; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zoster Vaccine (received in 2014).   On 19th August 2019 12:00, the patient received the 1st dose of Shingrix. In August 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, fever and chills. On 19th August 2019, the patient experienced injection site itching. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site itching, injection site erythema, injection site swelling and chills were unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the injection site itching, injection site erythema, injection site swelling, fever and chills to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on the left arm at around 12 noon on Monday. The patient stated that on same day evening, she had itching at the site. Less than a day after vaccination, the patient experienced injection site erythema, injection site swelling, fever and chills. During the night, on 20th August 2019, she had chills and a fever of 100.4 degree F. The patient took Ibuprofen for the fever and noted it lasted for about 24 hours. On 20th August 2019, on the next morning, she awoke with redness and swelling at the injection site of about 2 inches in diameter. The reporter was consented to follow up.
Post vax, pt had inconsolable crying X 1 to 1 1/2 hours.
1. 4/17 - 12 pm - bloody nose 2. 4/18 - 4 pm - low grade fever (100.1) 3. 4/18 - 4 pm headache
Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature; A spontaneous report was received from a pharmacist concerning 83 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and reported events like patient received a dose of the Moderna COVID-19 vaccine from a vial that went through a temperature excursion/improper storage of the product use.  The patient's medical history was not provided. No concomitant medications were reported.  On an unknown date, prior to the onset of the events, the patient received their first of the two planned doses of mRNA-1273(lot/batch: 027L20A) intramuscularly in the anatomical position for prophylaxis of COVID-19 infection.  On an unknown date, patient received a dose of the Moderna COVID-19 vaccine from a vial that went through a temperature excursion. Laboratory details were not reported.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event of patient received a dose of the Moderna COVID-19 vaccine from a vial that went through a temperature excursion was considered as resolved.
Chills began the evening of the date of vaccine around 7;15pm; headache, major body aches, fatigue began the next morning upon waking and chills persisted.  Symptoms lasted until the next morning for a total of about 36 hours since they began.
Fainted/LOC & trembling of extremities briefly <- not seizurelike tonic-clonic activity. Quickly regained consciousness and awakened - became alert/oriented. Felt dizzy -> resolved after resting minutes in clinic.
Received the COVID vaccine at work in her left deltoid 40 minutes prior to arrival to the ER.  Within 5 minutes of receiving it, serial blood pressure readings began rising, her arm felt heavy, and she developed an uncontrollable tremor primarily in her left arm with what appears to be generalized shivering.  Associated with significant anxiety. She has never had an allergic reaction before.  No associated shortness of breath or wheezing.  No lip tongue or throat swelling.  No pruritus or hives.  No nausea or vomiting.  She was treated for possible dystonic reaction initially with two doses of Benadryl 25mg IV, then 1mg of IV lorazepam, and finally 125mg solumedrol. Symptoms improved significantly with Benadryl, and then resolved entirely after lorazepam. She was discharged home to complete 4 more days of 50mg prednisone.