chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DEATH-CAUSE UNSPECIFIED; A report has been received from a physician via Merck medical representative, concerning a female patient.    Relevant medical history, concurrent diseases and concomitant medications were not reported.    On unspecified date, the patient received nasal FluMist (influenza virus vaccine live, intranasal).  Another vaccine was given on same day, quadrivalent human papilloma virus vaccine. It was unknown if the quadrivalent human papilloma virus injection was the first, second, or third in a series of three injections. The patient went back to the doctor's office the same day she received the injection for an unspecified reason.    The next day, the patient did not participate in gym class at school for an unspecified reason and died (preferred term: death) at an unknown time.  Cause of death was unspecified. It was unknown whether autopsy was performed.    The reporter assessed the case as serious with death criterion.; Sender's Comments: The case describes a female patient of unknown age who died after being treated with Flumist. The cause of death is not further specified. There is missing information on the cause of death, patient's medical history, concomitant medications, concurrent diseases and autopsy results making it difficult to assess a causal relationship.; Reported Cause(s) of Death: DEATH-CAUSE UNSPECIFIED
New guidelines were implemented yesterday where peds 6 month-5 yrs. now receive Moderna Bivalent "Dark Blue Cap" for 1st & 2nd dose of vaccine. I was confused and thought peds 6 months-5 years only got Moderna Bivalent "Pink Cap".  I administered 0.25mL of Moderna Bivalent "Pink Cap" to patient as first dose.
Received vaccination at 1400 on 15 Aug 2017 without complications. Around 1800 that day he started experiencing mild chest discomfort. Symptoms worsened and went to the ER on 16 Aug at 0519 and was diagnosed with pericarditis. Treated with NSAIDs/Tylenol.
cellulitis or hematoma @ inj site which was 3x6cm red & tender;tx Keflex & warm soaks
Patient c/o heaviness and numbness in both legs x 8 days - starting 2 days after H1N1 vaccination. C/o having no control over her legs-they move on their own, running into objects x 3 days. C/o blurred vision x 2 days.
Administered outside approved age. Patient is 16 y/o, Vaccine approved for 18 y/o.
Initial information and follow up has been received from a nurse practitioner concerning a 13 year old white female who on 14-NOV-2007 was vaccinated intramuscularly in the left arm with her first dose of GARDASIL (lot# 659437/1266U). There was no concomitant medication. On 15-JAN-2008 the patient was vaccinated intramuscularly in the left arm with her second dose of GARDASIL (lot# 656049/0187U). On 15-JAN-2008 the patient experienced headaches, vomiting and a fever. Subsequently the patient recovered from headaches, vomiting and a fever several days after the vaccination. She had no symptoms after the first GARDASIL. The patient sought medical attention by calling the office. On 16_MAY-2008 the patient was vaccinated intramuscularly in the left arm with the third dose of GARDASIL (lot# 659657/1487) with less reaction. Additional information has been requested.
Patient was given Moderna Covid Vaccine Booster #2, not Bivalent.  E-mail with this information recieved by nurse on same day.
Anaphylaxis fast heart beat sob like being on fast treadmill tongue swelling super high blood pressure the  next two days after I had really bad migraine and high fever of 102.3° with bad fatigue for 4 days.
red,indurated area w/5-10 blebs on rt mid forearm,well below site @ 24hrs;seen by occupational nurse 27OCT & 29OCT;29OCT94 rash had spread to lt arm & abd;referred to family MD for further treatment;
7/9/02 positive zoster. Clustered (oval erythematous based vesicular lesions ~ 2x5cm ). Varivax given 11/12/98.
About 6 weeks after getting ZOSTAVAX, pt came to pharmacy to fill a prescription for symptoms of Bell's Palsy. Said she had tearing of R eye and drooping eyelid. She had been diagnosed at her eye dr. Our pharmacy notified both Dr.'s pt had recently received ZOSTAVAX neither Dr has responded yet.
not a high temperature it is like 100 and half; real pain yesterday night at the injection site; Headache; Muscle pain; Chills; Little feeling of unwell like really tired; Little feeling of unwell like really tired; Flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A patient of unknown age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on unspecified date at single dose for COVID-19 immunization. Medical history and Concomitant medications were not reported. Patient stated, "Well I had the second shot of Covid 19 okay, and I am experiencing some symptoms and I had a temperature, not a high temperature it was like 100 and half so I don't know what the limits are. I had real pain last night at the injection site and I had 5 minutes like headache, some muscle pain, in morning I had chills, a little feeling of unwell like really tired, I had feeling like I had a flu like symptoms." The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
After administering pediatric vaccine, patient reported itchiness in whole arm that vaccine was given in. Patient's skin felt warm to the touch upon examination, but not red and no hives were observed. After examining patient, patient reported that she now felt itchy around her neck. Pharmacist gave patient 12.5mg of generic children's benadryl according to patient's weight and age with verbal consent of patient's mother. Pharmacist continued to observe patient's symptoms. Patient's symptoms subsided over the next 15 minutes. Pharmacist advised patient's mother on how and when to treat symptoms with benadryl at home if itchiness continued. Also counseled patient's mother on signs and symptoms of more severe/emergent allergic reactions such as hives and anaphylaxis if they occurred at a later time, and instructed her to call 911 if occurred. Gave patient's mother my card so she can call pharmacy with any other questions or concerns. Will call patient's mother tomorrow to follow up and check up on patient.
4" x 3 1/2" area of warmth, erythema starting after vaccine 5/15/13. Patient seen in clinic 5/17/13 started on KEFLEX (250/5) give 80 TID x 10 days. Follow up appt to be scheduled.
Chest Pain; palpitations; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest Pain), PALPITATIONS (palpitations) and DIZZINESS (dizziness) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0729J21B and 052C21A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 vaccination: Pfizer BioNTech (Dose Number: 1 Batch/Lot No: EW0216) on 25-May-2021. Past adverse reactions to the above products included No adverse event with Pfizer BioNTech.   On 19-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2022, the patient experienced CHEST PAIN (Chest Pain), PALPITATIONS (palpitations) and DIZZINESS (dizziness). At the time of the report, CHEST PAIN (Chest Pain), PALPITATIONS (palpitations) and DIZZINESS (dizziness) outcome was unknown. Not Provided          No concomitant and treatment medication were provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Gave Pt MMR on 2-2-09.  Paperwork signed by pt & guardian that she is not currently pregnant, no possible way she is pregnant & understands should not get pregnant for 3 months of receiving immunization.  Found out March 2, 2009 via  school nurse/doctor that pt was pregnant- pregnancy test taken a few weeks after shot.
The patient developed cellulitis of the left deltoid. The patient had redness and swelling of the injection site. The patient also experienced a headache and vomiting.
I had bloodwork for my Morphea were normal except for my ANA which was slightly elevated. Twelve hours after getting the first dose of vaccine I got a sharp nerve pain behind my left ear and down my jaw. For four days after that my jaw was very painful. Two weeks after the vaccine I started to get dizzy lightheaded, and my Heart Rate was spiking. I got chest vibrations and I was admitted to the hospitalized for one week. I got the second dose the after I was discharged. Twelve hours after the second dose I developed body vibrations all over my body. The next day I was having the tingling vibrations in my hands and feet. It lasted for five days. I was also experiencing Tachycardia. Two weeks after the second dose the nerve vibrations and Neuropathy sensations started again and it has been ongoing for over six months. My doctor said that it is mimicking Potts symptoms. I have also been under a Cardiologists care.
Information has been received from a physician concerning a 23 year old female patient who on approximately 06-MAR-2010 (two months ago) was vaccinated with a first dose of GARDASIL (Lot # 662304/1013Y, expired date 20-APR-2011). After vaccination, 8 hours later the patient experienced shortness of breath, joint stiffness and body aches. The patient went to the Emergency Department and was not treated or admitted as she recovered within few hours. Additional information has been requested. Patient went to the Emergency Department at medical center.
Typical arm pain as with other Covid shots, but on and off I am experiencing mild to moderate myalgias at site of injection despite that the shot was given 1 month ago. I have never experienced this with prior COVID vaccines (all moderna), or any other vaccines. It is quite a noticeable pain
Cough, headache, dizziness, body ache, chills, running  nose, numbness in throat and tongue
Soreness and swelling on her arm; Soreness and swelling on her arm; body aches, pain and her body hurt; Muscle pain/Body ache/ pain / body hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness and swelling on her arm), PERIPHERAL SWELLING (Soreness and swelling on her arm), PAIN (body aches, pain and her body hurt) and MYALGIA (Muscle pain/Body ache/ pain / body hurt) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness and swelling on her arm), PERIPHERAL SWELLING (Soreness and swelling on her arm), PAIN (body aches, pain and her body hurt) and MYALGIA (Muscle pain/Body ache/ pain / body hurt). At the time of the report, PAIN IN EXTREMITY (Soreness and swelling on her arm), PERIPHERAL SWELLING (Soreness and swelling on her arm), PAIN (body aches, pain and her body hurt) and MYALGIA (Muscle pain/Body ache/ pain / body hurt) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications reported.  No treatment information was reported by reporter.
LT DELTOID APPEARS RED AND SWOLLEN. CLIENT COMPLAINT OF PAIN AND WENT TO HOSPITAL 3/23/2006 AT AROUND 9:30 PM PER MOTHER.
Patient became very faint and nauseous 5-10 minutes after receiving the Pfizer COVID vaccine along with his brother. When supplied with a bucket, paper towels, and a cold compress pack, patient's brother began to vomit . Patient may have also passed out during this time period. The store manager was contacted  and emergency medical services were also contacted  due to severity of the reaction. the patient was taken to a local medical facility as of the writing of this report.
break-through Covid in February 2022, had symptoms of a head cold and thought they might be a side effect from my first chemo TCH cocktail
DEHYDRATION; UPPER GASTROINTESTINAL PAIN, STOMACH ISSUE; LOSS OF APPETITE; WEAKNESS; NAUSEOUS; HEADACHE/ MIGRAINE LIKE HEADACHE; MUSCLE ACHES; FATIGUE; VOMITING; SHORTNESS OF BREATH; This spontaneous report received from a consumer concerned a male of unspecified age. 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: 042A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, immediately after vaccination the patient experienced headache, muscle aches, fatigue. On 12-APR-2021, the patient went to urgent care which the patient was determined to have dehydration. The patient had been given 2 bags of IVs and nausea medication. Patient was having constant headaches and was feeling weak, nauseous, also had upper gastrointestinal pain, loss of appetite and migraine-like headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, shortness of breath, weakness, fatigue, and muscle aches on APR-2021, was recovering from loss of appetite, had not recovered from nauseous, and upper gastrointestinal pain, stomach issue, and the outcome of dehydration and headache was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0:-covid-19 vaccine ad26.cov2.s-Dehydration. 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).
Myopericarditis requiring hospital admission. Elevated trop and decreased EF on ECHO.
Pt received shot of DTaP on Fri 06/07/02, that night pt started screaming/crying. Pt didn't settle down all weekend. No other symptoms illness.
reactions to the second dose; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (reactions to the second dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0088712A and 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Alopecia and Vitiligo. Concomitant products included TRAZODONE for Sleep disorder.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reactions to the second dose). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and FLUFENAMIC ACID (PARAFLU [FLUFENAMIC ACID]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (reactions to the second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications: yes, does not want to disclose further. Patient has chemical reaction 3 years ago,also for one year she has sweats: constantly wet and dripping. Her PCP took her off from trazadone (for sleep) 2weeks ago, but she still gets the sweats.   This case was linked to MOD-2021-343810 (Patient Link).
muscle weakness around the injection site (mild); Arm pain at injection site (mild); This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE MUSCLE WEAKNESS (muscle weakness around the injection site (mild)) and VACCINATION SITE PAIN (Arm pain at injection site (mild)) in a 41-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 202F23A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In September 2023, the patient experienced INJECTION SITE MUSCLE WEAKNESS (muscle weakness around the injection site (mild)) and VACCINATION SITE PAIN (Arm pain at injection site (mild)). At the time of the report, INJECTION SITE MUSCLE WEAKNESS (muscle weakness around the injection site (mild)) and VACCINATION SITE PAIN (Arm pain at injection site (mild)) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant medication not reported.   Treatment medication not reported.
Large red, inflamed, circle around injection site, roughly 2 inches in diameter. Hard under skin, hot to the touch. not painful, or itchy. Have not gone to doctor yet, waiting to see if it goes away in a couple days.
Loss of smell; Tested positive for COVID 19after vaccine; Loss of taste; Nasal congestion; Runny nose; Headache; Nausea; Vomiting; Fever of 101 F; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID 19after vaccine), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), NASAL CONGESTION (Nasal congestion) and RHINORRHOEA (Runny nose) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID 19after vaccine), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), NASAL CONGESTION (Nasal congestion), RHINORRHOEA (Runny nose), HEADACHE (Headache), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever of 101 F). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID 19after vaccine), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), NASAL CONGESTION (Nasal congestion), RHINORRHOEA (Runny nose), HEADACHE (Headache), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever of 101 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     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.   Treatment medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Add  COVID-19 PCR test. Add events headache, nausea, vomiting, loss of taste and loss of smell.
she had a heart attack; She was not scheduled for the second dose and missed it/ Missed second dose > 5 months; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (she had a heart attack) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (She was not scheduled for the second dose and missed it/ Missed second dose > 5 months). On 22-May-2021, the patient experienced MYOCARDIAL INFARCTION (she had a heart attack) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 22-May-2021 to 25-May-2021 due to MYOCARDIAL INFARCTION. The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Anticoagulant therapy, at an unspecified dose and frequency; PRASUGREL for Anticoagulant therapy, at an unspecified dose and frequency and Surgery (2 stents had put in) for Myocardial infarction. On 20-Mar-2021, PRODUCT DOSE OMISSION ISSUE (She was not scheduled for the second dose and missed it/ Missed second dose > 5 months) had resolved. At the time of the report, MYOCARDIAL INFARCTION (she had a heart attack) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Patient reported that she had no history of heart problem.  Company comment: This is a case of Product dose omission of this 58-year-old, female patient, with no known medical history, who experienced the serious, unexpected, AESI event of Myocardial infarction. The event occurred  2 months after first dose of Moderna vaccine. The rechallenge is not applicable as patient only received first dose. The long onset latency of 2 months remain as confounder to the event. The benefit-risk relationship of Moderna vaccine is not affected by this report.   This case was linked to MOD-2021-349207, MOD-2021-006363 (Patient Link).; Sender's Comments: This is a case of Product dose omission of this 58-year-old, female patient, with no known medical history, who experienced the serious, unexpected, AESI event of Myocardial infarction. The event occurred  2 months after first dose of Moderna vaccine. The rechallenge is not applicable as patient only received first dose. The long onset latency of 2 months remain as confounder to the event. The benefit-risk relationship of Moderna vaccine is not affected by this report.
Large rash at point of injection started 8 days after vaccination. Slight itching and tender to touch. Lasted 6 days
This case was reported by a other health professional via sales rep and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: This case was reported by an Office Manager who was also the patient. The age at vaccination was not reported. On an unknown date, the patient received the 1st dose of SHINGRIX. Ten weeks after receiving the 1st dose, the patient received the 2nd dose of SHINGRIX. The patient experienced fever (body temperature greater than 103 degree F) for 2 days. The fever lasted for 2 days. The reporter did not agree for follow up. Lab Comments: On an unknown date, the patient's body temperature was recorded greater than 103 degree F.
Information has been received from a nurse practitioner concerning an 80 yr old female pt with a history of three previous vaccinations with pneumococcal 23v polysaccharide vaccine, who in the last 10 days (approx Sep 2005) was vaccinated with a fourth dose of pneumococcal 23v polysaccharide vaccine (lot 649914/0578P). It was reported that within one day of the vaccination (approx Sep 2005), the pt developed an injection site reaction. Her arm was sore and weak, and she also developed malaise, fatigue. There was no treatment at this time. There was no other information available regarding the adverse event or the pt's outcome. There was no product quality complaint reported. The pt sought unspecified medical attention. Additional information has been requested.