chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heart fluttering; Palpitations; Gray skin pallor; This is a spontaneous report from a contactable nurse. A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date was not reported), via an unknown route of administration on 09Apr2021 single dose for COVID-19 immunization. The patient medical included Psoriatic arthritis, hypermobile joints, chronic fatigue, hypermobile joints, and Iron dextran complex. Patient previously took first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number and expiration date was not reported), via an unknown route of administration on 19ar2021 as single dose for covid-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient concomitant medication included Benzoyl peroxide, clindamycin phosphate (BENZACLIN); Celecoxib (CELEBREX) for arthritis; Loratadine (CLARITIN (LORATADINE)); Secukinumab (COSENTYX); Bisacodyl (DULCOLAX (BISACODYL)); Multivitamin (VITAMINS NOS); Prednisone; Senna acutifolia; Vitamin D3 and Diclofenac Potassium (VOLTAREN). On 30Apr2021, the patient experienced heart fluttering, palpitations, gray skin pallor. Occurs randomly, lasting 20-30 seconds per episode. The clinical outcome of the heart fluttering, palpitations, gray skin pallor was recovered on an unspecified date in 2021.  Follow up needed; Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported Cardiac flutter and the use of BNT162B2 cannot be fully excluded. The case will be assessed further upon receipt of additional information.  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.
Within 2 minutes of Injection patient felt shortness of breath briefly (seconds) and then her entire head felt hot. Patient also felt pain in her lower back in the kidney area. Resolved within 5 minutes.
Patient came in for a flu shot. It was administered into his left deltoid. After we were complete he went downstairs and started feeling tingling in both of his arms from the elbow down. He described his thumbs as locking where he couldn't bend them. He also felt faint so he sat down. We called 911 and by the time they evaluated him they decided that he was probably ok and he did not go to the hospital.
Death; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) and COVID-19 (COVID-19) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DEATH (Death) (seriousness criteria death and medically significant) and COVID-19 (COVID-19) (seriousness criterion death). The reported cause of death was covid-19. It is unknown if an autopsy was performed.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) COVID-19 test Positive..         No concomitant medication information was mentioned by reporter  No treatment medication information was mentioned by reporter; Reported Cause(s) of Death: COVID-19
SHORTNESS OF BREATH; UNABLE TO WALK; BRUISE IN THE STOMACH; HEADACHE; ARM PAIN; This spontaneous report received from a patient concerned a 48 year old 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 (suspension for injection, route of admin not reported, and batch number: 09041738 expiry: UNKNOWN) dose was not reported, administered on 16-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-JUN-2021, the subject experienced arm pain. On 19-JUN-2021, the subject experienced headache. On JUL-2021, the subject experienced bruise in the stomach. On an unspecified date, the subject experienced shortness of breath, and unable to walk. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, had not recovered from arm pain, bruise in the stomach, and shortness of breath, and the outcome of unable to walk was not reported. This report was non-serious.
Information has been received from a licensed nurse concerning a 69 year old white female who on 21-APR-2008 was vaccinated with zoster vaccine live (Oka/Merck) injection (lot# 659763/1875U). On 25-APR-2008, the patient experienced a rash under her right breast spreading to the right side and right back. The patient was being treated by a physician at the time of reporting. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008.  Information has been received from a licensed practical nurse concerning a 69 year old female with no drug allergies who on 21-APR-2008 was subcutaneously vaccinated into left arm with ZOSTAVAX (Merck) injection (lot# 659761/1875U).  On 25-APR-2008, the patient experienced a rash under her right breast spreading to the right side and rigth back.  The patient was being treated by a physician.  The physician did diagnose with shingles when the patient was seen.  As the time of report the patient didn't recover.  No further information is available.
Patient reported 1 week after vaccination left elbow turned black and is still black. Does not remember bumping it in any way. No pain.
post HPV vaccine; This spontaneous prospective pregnancy report was received from registered nurse and refers to a 26 year old female patient. The patient had no previous pregnancies and noted medical history. Concomitant therapies were not reported.   The patient's last menstrual period was on 07-DEC-2019 and the patient became pregnant. During the first trimester of pregnancy the patient had anemia.  On 17-JUN-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1614898 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast, expiration date not reported, but upon internal validation established as 15-NOV-2021  for prophylaxis (dose and route of administration was not reported) (Vaccine exposure during pregnancy). On 06-JUL-2020, due to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  vaccination, an ultrasound conducted by a maternal-fetal medicine (MFM) specialist was performed and  normal fetal growth activity was seen. Estimated date of delivery (EDD) was for 09-SEP-2020. The pregnancy outcome was pending. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: 1614898; expirationdate: 15-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Chills, nausea, vomiting, severe body aches, fatigue, arm pain
I experienced itchy, light rash, and red soreness in area of injection. I had Moderna COVID-19 vaccine on Feb 13, 2021. It is now Feb 21, 2021 and not much  improvement after a week
Headache, nausea, diarrhea, chills, rash on arm, soreness at injection site, joint and muscle pain, extreme fatigue. Basically ALL the side effects known with this drug.
Large swelling, erythema, and pain on right arm.  Led to follow up office visit
Pt received the vaccine the morning of 4/6/2023. Mother  called the morning of 4/7/2023 and reported that her child had a rash. She described the rash as little skin colored like bumps. They were not red during the time of the call and the redness that was at there, had gone away. She stated the child was not itching and that the area was not warm to the touch. She stated the rash was located between the right collarbone and chest. The mother stated she did not have to give any type of medication. She stated she did not notice the rash the night of the  vaccine but saw it the morning of 4/7/2023 when the child got out of bed.
Sharp shooting pain in arm. 17484486/10 pain (a lot of pain). I don?t want to move my arm because it hurts so much. And I have a high pain tolerance because one time a nurse told me ?how did you not feel pain when he was razor blading your vagina?? This shit hurts, bro
High fever, convulsions or seizures lasting for 4 hours. I passed out and do not remember anything else.  I have never had this happen before. I also felt like I had a kidney infection or the pain and discomfort was radiating from the hip bone.
did not receive second dose in recommended 42 day timeframe; Extreme muscle pain; fatigue; spikes in fever between 100 and 103.4 degrees Fahrenheit; felt strange; rise in temp/fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt strange), PRODUCT DOSE OMISSION ISSUE (did not receive second dose in recommended 42 day timeframe), PYREXIA (rise in temp/fever), PYREXIA (spikes in fever between 100 and 103.4 degrees Fahrenheit) and MYALGIA (Extreme muscle pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 and Infection (Infection in March and it took months to get better.) in March 2021.    On 14-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 FEELING ABNORMAL (felt strange) and PYREXIA (rise in temp/fever). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not receive second dose in recommended 42 day timeframe), PYREXIA (spikes in fever between 100 and 103.4 degrees Fahrenheit), MYALGIA (Extreme muscle pain) and FATIGUE (fatigue). On 17-Jan-2021, PYREXIA (rise in temp/fever) had resolved. At the time of the report, FEELING ABNORMAL (felt strange), PRODUCT DOSE OMISSION ISSUE (did not receive second dose in recommended 42 day timeframe), PYREXIA (spikes in fever between 100 and 103.4 degrees Fahrenheit), MYALGIA (Extreme muscle pain) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications listed.  No treatment listed.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up included: Patient history, product information, adverse event information.
Pt developed progressive weakness and numbness, rash on the chest shortly after vaccination.  Diagnosed with Guillain Barre syndrome.  Also a case of having received attenuated live flu vaccine and anthrax vaccine close in time together.  2 cases of Guillain Barre in patients this week seen at this hospital.   10/30/09:  Vaccination and Medical Records received for dates of service 10/28/09 to 10/30/09.  Dx.  Guillain Barre syndrome. Assessment:  Presented with 3 day history of fatigue, numbness in left and right hands and forearms, abdomen and left foot, SOB and difficulty with ADL's, requiring assistance with ADL's prior to presenting.  Additionally, he c/o a rash on his chest. Head CT Normal, CSF protein elevated. Nerve conduction studies-Abnormal.
Cardiomyopathy STEMI (ST elevation myocardial infraction )  Heart failure with reduced ejection fraction  Elevated Troponin (47.073) Elevated D-Dimer (560)
Cellulitis - seen in ER; tingling - shoots from feet, hands --> arms 10/7 vaccine; 10/8 cellulitis --> CIPRO --> x 1 dose worsened A to CEPHALEXIN 10/09 --> tingling/nausea 10/9 - 10/10/10 to current.
patient younger than 18 years of age received Moderna shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient younger than 18 years of age received Moderna shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient younger than 18 years of age received Moderna shot). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient younger than 18 years of age received Moderna shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported
Patient noted dark stools and presented to office 2/23/2021. ITP with platelet count of 2K. Successfully treated with standard dexamethasone dosing. No adverse complications. Has a hx of ITP presumed due to viral infection in 2016.
Very sick since then; sweating; Lack of appetite; weak; Shaking; tired; chills; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Very sick since then), HYPERHIDROSIS (sweating), DECREASED APPETITE (Lack of appetite), ASTHENIA (weak) and TREMOR (Shaking) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Very sick since then), HYPERHIDROSIS (sweating), DECREASED APPETITE (Lack of appetite), ASTHENIA (weak), TREMOR (Shaking), FATIGUE (tired) and CHILLS (chills). At the time of the report, ILLNESS (Very sick since then), HYPERHIDROSIS (sweating), DECREASED APPETITE (Lack of appetite), ASTHENIA (weak), TREMOR (Shaking), FATIGUE (tired) and CHILLS (chills) had not resolved.            Concomitant medications were not provided.  Treatment information was not provided by reporter.   Action taken with the drug in response to the events was not applicable.
Sore arm by evening- hurt to touch.                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Sore arm by evening - hurt to touch. Woken several times during the night, shivering, feverish. Nausea and headache next day preventing me from going to work. Recovered by late afternoon the day following the vaccination.                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Sore arm by evening- hurt to touch. Woken several times during the night
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 24Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN, start date: 01Jan2019, stop date: 02Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical details: On 12Jun2022, covid rebound 6 days after completing 5 day treatment of Paxlovid from 02Jun2022 to 06Jul2022 for covid-19. Mild symptoms initially and in rebound. No treatment given for AE. The AE was recovering.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Had MMR and Varivax on 04/03/2001. Developed shingles on 09/27/2001, Rt flank, diagnosed by MD on 10/01/2001.
In 1/10/2022, I was travelling abroad and someone in this tour was sick and then I got sick, and I tested for COVID-19 for 4 days and it was all negative. I had like a bad sinus. I was very tired and had a lot yellow mucus and was coughing and did not take temperature. My hearing was terrible and there was pressure on head. I went to urgent care on 10/21/2022 and they gave me FLONASE and a medicine, decongestant. I also had problems in my ear, and it was muffled. ER while abroad on 10/27/2022. He said that it may be a serious sinus infection. I had pain and muffled hearing in my ears and was given pain medication I could not hear people calling my name in the ER. When I came back home, I went to a local clinic, appt on 11/29/22. No tests were done and gave me prednisone and they sent me to a specialist ? ENT on 12/2,19 and 22/2022 when I came back, and my symptoms have not improved. I felt like that is fluid in my ears I was given FLONASE and a NETTI POT. They told me to be patient and to come back in Oct2023 and to put tubes to drain the fluid even if it won't have much difference. I now have mild headaches which is not normal for me since I got back home from Nov 2022 onwards.
Patient presented with significant swelling 2 days after vaccination administration, approx 4" by 6" and red/warm to touch. Advised by another PHN to apply compress PRN and RTC if swelling worsened or did not resolve.
Throat lymph nodes are swollen and hard (both sides), it's tender to touch; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Throat lymph nodes are swollen and hard (both sides), it's tender to touch) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No concomitant medications were provided. No treatment information provided.     On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced LYMPHADENOPATHY (Throat lymph nodes are swollen and hard (both sides), it's tender to touch). At the time of the report, LYMPHADENOPATHY (Throat lymph nodes are swollen and hard (both sides), it's tender to touch) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were provided. No treatment information provided.   Reporter did not allow further contact
Patient had severe arm pain, not only at injection site, but entire arm. She was not able to lift her arm or use her arm for everyday activities. There was no visible swelling or redness at injection site. She was not able to sleep at night. She did not have a headache. The extreme arm pain lasted 2 days, then she felt fatigued for the next 2 days, by the 5th day she felt fine.
Erythema, induration, tenderness at injection site left deltoid, left upper arm. No fever. Symptoms resolved after 5-7 days.
Stop talking, diarrhea, vomiting, picky eater, no pointing, no eye gaze or contact, self absorbed. Follow Up: still severely devlopment delays, expressive language delays, fine motor delays, recurring GI problems, severe issues with food choices, side ways ofances, still detoxing of heavy metals. I feel my child has been robbed of his childhood/rest of his life. I hope in time that the responsibe party/parties will be held accountable.
Information has been received from a pharmacist concerning an 89 year old retired white female, who was unsure if she had chickenpox, who on 29-AUG-2007 was vaccinated with a 0.65 ml subcutaneous dose in the left arm of zoster vaccine live (Oka/Merck) (Lot# 658083/0885U). Concomitant therapy included nitroglycerin, sertraline HCl, atorvastatin calcium (LIPITOR), levothyroxine Na and ranitidine. On 29-AUG-2007 the patient experienced rash around injection site. The patient stated to the reporter that the rah was not bothering her. She was counseled to keep an eye on it and to inform the reporter if it worsened. On the evening of 31-AUG-2007 the reporter inspected her arm and said it was clear of the rash. The patient was considered to be recovered on 31- AUG-2007. Additional information is not expected.
INJECTION SITE PAIN; This spontaneous report received from a consumer concerned a 60 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 09-JUN-2021) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced injection site pain. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 25-MAR-2021. This report was non-serious.
Headache, NauseaVomiting, fatigue/somnolence, loss of taste Narrative: Per pt. report: "...had extreme fatigue that started about 7:30PM [1/21/21 day of vaccination] along with a headache. I started taking Tylenol. I telework and did not work Friday [1/22/21] due to being so fatigue that I could not stay awake and continued to have a headache. This continued thru Friday and up until noon on Saturday. I felt nauseous up until Sunday evening. I have also lost my sense of taste, but still have my sense of smell. I have not had a fever. "