chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt a little disoriented; anxious; tingling in his left arm/tingling of the face from chin going upward/tingling on his chin; flushing of the face from chin going upward; face felt swollen; his heartbeat was rapid; tingling on his lower lip; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (felt a little disoriented), ANXIETY (anxious), PARAESTHESIA (tingling in his left arm/tingling of the face from chin going upward/tingling on his chin), FLUSHING (flushing of the face from chin going upward) and SWELLING FACE (face felt swollen) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol high and Allergic reaction (Red dye).    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced DISORIENTATION (felt a little disoriented), ANXIETY (anxious), PARAESTHESIA (tingling in his left arm/tingling of the face from chin going upward/tingling on his chin), FLUSHING (flushing of the face from chin going upward), SWELLING FACE (face felt swollen), HEART RATE INCREASED (his heartbeat was rapid) and PARAESTHESIA ORAL (tingling on his lower lip). On 22-Apr-2021, DISORIENTATION (felt a little disoriented) and ANXIETY (anxious) had resolved. On 23-Apr-2021, PARAESTHESIA (tingling in his left arm/tingling of the face from chin going upward/tingling on his chin), FLUSHING (flushing of the face from chin going upward), SWELLING FACE (face felt swollen) and HEART RATE INCREASED (his heartbeat was rapid) had resolved. At the time of the report, PARAESTHESIA ORAL (tingling on his lower lip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Patient was advised Benadryl and Tylenol by the doctor, but the patient didn't take either.
Cancer; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (Cancer) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced NEOPLASM MALIGNANT (Cancer) (seriousness criteria death and medically significant). The reported cause of death was Cancer. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NEOPLASM MALIGNANT (Cancer) to be related.    No concomitant medication was reported.  No treatment information was reported.  This case contains information for patient 15 out of 25.  Company comment:  This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the Fatal serious (due to medically significant) unexpected, event of Neoplasm malignant, which occurred after the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as part of COVID-19 vaccination schedule, dose number not provided. The patient died on an unknown date, and it is unknown whether an autopsy was performed. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-735987 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735987:Master case, Patient 1; Reported Cause(s) of Death: Cancer
This spontaneous report was received from a quality control individual at a medical facility refers to a patient of unknown age. on 08-NOV-2012, the patient was vaccinated with a dose of MMR II (lot # 0682AE, exp: 02-APR-2014) (Dose and route were not reported). NO other co-suspects were reported. No concomitant medications were reported. The reported called for a patient who was administered MMR II that was exposed to an unsupported temperature excursion (10.1C for 96 hours). No adverse effect reported. This is one of seven reports from the same source. Additional information has been requested.
A non-serious spontaneous report of tachycardia and generalized rash has been received from a physician concerning a 38-year-old female, subsequent to receiving FLUMIST. Medical history included allergy to ampicillin, penicillin and acetaminophen. Concomitant medications were not reported for this patient. On 20-Jan-2011, the patient received one dose of FLUMIST intranasal for flu vaccination. A few minutes after receiving the vaccination, the patient experienced tachycardia and a generalized rash. The outcome of the events was unknown.
Red, raised rash, bilat. forearm, shins, shoulder started 1 week after immunization. Cleared with HC 1% cream.
NIGHT OF VACCINATION HAD FEVER, CHILLS, SEVERE BODY ACHES. FELT MUCH BETTER IN MORNING.
Information has been received from a physician concerning a 4 month old male who on 21-SEP-2007 was vaccinated with a second oral dose of ROTATEQ. Concomitant vaccine included a dose of PEDIARIX. On 24-SEP-2007 the patient had discoloration of stools were black in color. The patient was seen on by the physician on 24-SEP-2007 and the stools were normal. It was noted that the patient was only breast milk. No product quality complaint was involved. No other informtion was provided. Additional information has been requested.
Chills; Fever (100.5F); This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (Fever (100.5F)) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever (100.5F)). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event NOS, at an unspecified dose and frequency. On 03-Mar-2021, CHILLS (Chills) and PYREXIA (Fever (100.5F)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
pt rcvd vax; pt had unconsolable crying>3 hrs in duration occuring about 6 hrs after inject; peaked appearance;
Narrative: 7/30- COVID positive 7/31- reports fatigue, runny nose, symptoms improving
Ringing in ears; This is a spontaneous report from a contactable nurse (patient). A 55-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL1284, expiry date not reported), intramuscular on 06Jan2021 at a single dose into left arm as COVID prevention. There were no medical history and concomitant medications. Patient did not receive any other vaccines on the same day as the COVID Vaccine. Patient received the COVID shot on Wednesday (06Jan2021), and about two hours after she got the shot, she starting having godawful ringing in her ears that lasted the last two days. Patient confirmed that the product was not specifically prescribed to her, but rather it was given via workplace policy. The ringing in her ears started that same day (06Jan2021) and that the ringing has stopped, it stopped around 5:30 am morning of the report date (08Jan2021). Therapeutic measures were taken as a result of ringing in ears. Patient stated that she took Benadryl before bed last night (07Jan2021). The event ringing in ears recovered on 08Jan2021 at 5:30 am.
varicellaform rash; This case was reported by a physician via other manufacturer and described the occurrence of varicella-like rash in a adult 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 varicella-like rash. On an unknown date, the outcome of the varicella-like rash was unknown.   It was unknown if the reporter considered the varicella-like rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received Shingrix vaccine and developed varicella form rash. No other information was reported.
Patients that were administered expired doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients that were administered expired doses) 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 EXPIRED PRODUCT ADMINISTERED (Patients that were administered expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients that were administered expired doses) had resolved.        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 were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Non-significant follow up includes email id updated.
COVID Vaccine Breakthrough Case  Pfizer Dose 1 3/25/21 (ER2613) Pfizer Dose 2 4/16/21 (Er8732) COVID Positive 12/22/21 COVID Positive 12/24/21  12/24/21: Pt states she always feels short of breath but states it's worse today. States she is having issues at work and when she thinks about it, sob gets worse. Denies pain, Has been having chills, body aches, fever and tested for covid but no results  12/29/21: Shortness of breath (Reason For Visit, Emergency medicine, Medical). INR deviation from target (Working, Medical). Hyperglycemia (Working, Medical). Generalized idiopathic epilepsy, not intractable, without status epilepticus (Discharge, Medical). Elevated liver enzymes level (Working, Medical). COVID-19 pneumonia (Working, Medical).
Extreme fatigue, body aches, headache, chills, fever, and nausea
PATIENT CALLED PHARMACY ON 11/20/23 AND REPORT PAIN  , SHORE AND ITCHING AT INJECTION SITE
Redness on arm; Soreness; Hard time breathing; Squeaking to breath; No taste buds; No appetite, loss 9 pounds; Felt like she had covid; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness on arm), LIMB DISCOMFORT (Soreness), DYSPNOEA (Hard time breathing), WHEEZING (Squeaking to breath) and AGEUSIA (No taste buds) in an 82-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 03-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 DYSPNOEA (Hard time breathing), WHEEZING (Squeaking to breath), AGEUSIA (No taste buds), DECREASED APPETITE (No appetite, loss 9 pounds) and MALAISE (Felt like she had covid). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness on arm) and LIMB DISCOMFORT (Soreness). At the time of the report, VACCINATION SITE ERYTHEMA (Redness on arm), LIMB DISCOMFORT (Soreness), DYSPNOEA (Hard time breathing), WHEEZING (Squeaking to breath), AGEUSIA (No taste buds), DECREASED APPETITE (No appetite, loss 9 pounds) and MALAISE (Felt like she had covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Fever (102.5), stuffy nose, headache, bodyaches, chills.  After 3 days of <102.5 temps (they came down to around 100 with Motrin/Tylenol treatments) but then a cough started and is still a little bothersome today (Tues 10/27/2009). She is recovering but not back to 100% as of yet.  I have reported these issues to the pediatrican on Sun (10/25) and again on Mon (10/26) when her fever had broken but returned the following evening.
11:00AM had vaccine, 2:30 yesterday had abdominal distention  with URQ pain. Which can happen when I am fighting something.  Became very tight requiring nebulizer treatments. And have needed about every 2 hrs since.  Fever 103.2 starting about 7AM for about four hours.. nausea and vomiting (x2) around 11:00 AM. Massive headache. Liver pain and burning sensation in lungs. Which would come and go.   Now at 5:00 having  muscle aches starting. Been absolutely horrible feeling
Warmth; Diarrhea; Nausea; Fatigue; Redness; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warmth), DIARRHOEA (Diarrhea), NAUSEA (Nausea), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Redness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warmth), DIARRHOEA (Diarrhea), NAUSEA (Nausea), FATIGUE (Fatigue), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling). At the time of the report, VACCINATION SITE WARMTH (Warmth), DIARRHOEA (Diarrhea), NAUSEA (Nausea), FATIGUE (Fatigue), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow up was received on 19-may-2021 and no significant information was provided.
Abdominal cramping approx 2 hours after first shot was taken. Followed by bloating, inflammation and frequent bowel movements for a week. Then exactly 1 week later from day of first vaccine shot had diarrhea with abdominal spasms. Then 2 days later had diarrhea again with continued abdominal spasms, extra bloating, and inflammation in locations of endometriosis. This happened with menstrual cycle for that same week. For a total of 2 weeks of abdominal inflammation and spasms continue as of 7/21/21.  Consulting with doctors.
I sure feel fluish after I get a glue shot; Initial information was received on 11-Nov-2020 regarding an unsolicited valid serious case received from a consumer or non-health care professional via social media.   This case involves a patient (unknown demographics) who felt fluish (influenza), after the patient received vaccine INFLUENZA VACCINE (glue shot).  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, (Unknown latency), the patient felt fluish (influenza), after getting INFLUENZA VACCINE (glue shot).  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There will be no information available on batch number for this case.
Triggered debilitating shingles in my husband /painful shingles and need to be hospitilized; Pain; This spontaneous case was reported by an other health care professional and describes the occurrence of HERPES ZOSTER (Triggered debilitating shingles in my husband /painful shingles and need to be hospitilized) and PAIN (Pain) in a male patient of an unknown age 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, the patient experienced HERPES ZOSTER (Triggered debilitating shingles in my husband /painful shingles and need to be hospitilized) (seriousness criterion hospitalization) and PAIN (Pain) (seriousness criterion hospitalization). At the time of the report, HERPES ZOSTER (Triggered debilitating shingles in my husband /painful shingles and need to be hospitilized) and PAIN (Pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported.  Company Comment: This case concerns a male subject of unknown age, with no relevant medical history, who experienced the serious unexpected events of Herpes zoster and Pain. The events, which resulted in hospitalization, occurred unknown number of days after the administration of the second dose of mRNA-1273 vaccine. At the time of the report, the outcome of the events was Unknown. Rechallenge is not applicable as no information about adverse event/s and its/their resolution following the first dose is available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Follow-up report contains No new information (NNI).; Sender's Comments: This case concerns a male subject of unknown age, with no relevant medical history, who experienced the serious unexpected events of Herpes zoster and Pain. The events, which resulted in hospitalization, occurred unknown number of days after the administration of the second dose of mRNA-1273 vaccine. At the time of the report, the outcome of the events was Unknown. Rechallenge is not applicable as no information about adverse event/s and its/their resolution following the first dose is available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
I recieved the shot in my right arm, it was given to me at pharmacy by a Pharmacy Tech. She gave me the shot at the EDGE of my arm, not center. I went to sleep so I can rest. I woke up sleeping on my side, my arm was Tingly/Pins/Needles. I didnt think nothing of it until the next morning when it didnt go away. I called the Pharmacist at the pharmacy to ask him if that was normal, he said "No it is not normal,  If that doesn't go away in another day or 2 please go see your doctor. I saw my doctor I reported it since then I have been to the neurologist 2 times and and I have found no relief I am in severe pain I live in chronic pain my life is miserable I have been prescribed gabapentin but it does not help me this has been the most miserable month and a 1/2 of my life I wish I never even took the stupid shot. I need help I have 2 doctors seeing me as well as neurologist neurologist and endocrinologist endocrinologist as well as massage therapist a chiropractor chiropractor and an acupuncturist. All of this and I still have no relief I am in deep pain I have no relief I am in deep Payne I have even tried to get help from CBD and I get some relief but it's very temporary. I never had any type of pain in my life until I took the 2nd shot and it's the biggest regret I have. Please help me.
After vaccines he was walking in the exam room, mother noted him having a tonic movement of his arms and trunk and he fell back against her, dad noticed eyes rolled back, he became responsive and said he felt tired, afterwards he remained here for about 20 minutes and at first was pale, sensorium seemed clear to me and to parents, took popsicle and juice (had eaten). Offered to observe longer but parents feel comfortable w his condition and will take him home. He is able to walk and jump in hallway.
This spontaneous report as received from a Certified Medical Assistant refers to unknown number of patients of unknown demographics. There was no information about the patients' concurrent conditions, concomitant therapies, drug reactions or allergies and medical history provided. On an unknown date, the patients were inadvertently administered VAQTA lot # M027879, expiration date 24-JAN-2018 (formulation, dose, route of administration were not reported) and VAQTA lot # M033611, expiration date 02-MAR-2018 (formulation, dose, route of administration were not reported) that had been improperly stored. No adverse effects were reported. The vaccines experienced a temperature excursion of 47 Fahrenheit degrees (F) for 5 minutes, which was detected by a digital data logger. There was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted. Sender's Comments: US-009507513-1612USA012239: US-009507513-1701USA002061: US-009507513-1701USA002059.
left eyelid swelling around the eyelash line; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 11:45 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Patient had no relevant medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 11:00, the patient experienced left eyelid swelling around the eyelash line, causing discomfort in both eye. The patient was not sure if it was an allergic reaction to some new makeup she bought, but she don't know. The patient did not receive any treatment for the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event left eyelid swelling around the eyelash line was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Fever began one hour post vaccination- 102.9, c/o HA a few hours later. Relief with Tylenol, but fever returns within 4 hours
Developed left arm pain, followed by chills/fever, body aches, headache, and cough.  Weakness and fatigue. Then followed by nausea.
The PT was administered a lessor dose of pfizer covid vaccine. .2cc VS .3cc given IM LT deltoid
Patient presented to emergency department on 1/15/2022 for low back pain with right extremity weakness. She was found to be COVID-19 positive during screening for admission.  Patient was asymptomatic for COVID-19 infection during admission and required no management or supportive care. Patient was discharged to skilled nursing facility on 1/26/2022.