chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported; MMR II involved in temperature excursion on 01/01/2021; This spontaneous report was received from a medical assistant referring to a 12 months old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions and allergies were not provided.     On 29-JAN-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status recombinant Human albumin (rHA) (strength, dose and route were not provided; lot# was S037500 and expiration date was 20-NOV-2021) involved in temperature excursion (on 01-JAN-2021) for prophylaxis (product storage error). No additional adverse event reported.   The administered dose experienced a temperature excursion at 47.01 Fahrenheit for 1 minute 30 seconds. There was no previous temperature excursion. The temperature excursion was detected by a data logger.  This is one of the 16 cases received from the same reporter.; Sender's Comments:  US-009507513-2102USA005232: US-009507513-2102USA005231: US-009507513-2102USA005230: US-009507513-2102USA005229: US-009507513-2102USA005228: US-009507513-2102USA005227: US-009507513-2102USA007564: US-009507513-2102USA007563: US-009507513-2102USA007562: US-009507513-2102USA007561: US-009507513-2102USA007559: US-009507513-2102USA007558: US-009507513-2102USA007557: US-009507513-2102USA007556: US-009507513-2102USA003923:
Dizziness; Aches; Weak; Fever; Nausea; DIED; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (DIED) in a 62-year-old male 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 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), PAIN (Aches), ASTHENIA (Weak), PYREXIA (Fever) and NAUSEA (Nausea). The patient died on 18-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, DIZZINESS (Dizziness), PAIN (Aches), ASTHENIA (Weak), PYREXIA (Fever) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that the vaccine was not the cause, he had other medical issues too.  This is a case of sudden death in a 62-year-old male patient with unknown medical, who died 12 days after receiving first dose of vaccine. Very limited information has been provided at this time.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: New event (death) and narrative was updated.; Sender's Comments: This is a case of sudden death in a 62-year-old male patient with unknown medical, who died 12 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death
No adverse Event. The patient is only 16 years old and should not have receive the vaccination.
Information has been received from a nurse concerning an unspecified number of unspecified patients of unknown age and gender. No current or historical conditions were reported. On unspecified dates, the patients were vaccinated with improperly stored doses of COMVAX (route, dose, Lot# and expiration date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter was not allowed to be contacted.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Patient was seen at ER on 7/8/22 for overall rash and lips swelling, then Urgent care on 7/10/22 due to lips started to swell after being out in the sun.  She was put on oral steroids.  Skin biopsy done from rash on trunk, awaiting result (by derm).  RE benadryl and epi-not sure if given. Pt will also be reporting.
Severe Pain in left elbow, painful to move, painful to touch. Then swelling began spreading up and down arm from either side of elbow.  Eventually swelling was up to shoulder and down to fingers.  Shot was administered in left arm with only minor pain near injection site for 1st couple of days.
Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Mild, Additional Details: got emotionally excited after shot fainted for 25 seconds, patient was tired bur responsive
Pt given 4th shot in series 15 days prior to due date. A follow up report received 8/12/2003 adds: No adverse event. Verification of vaccination given out of sequence.
Received the 2nd shot on 2/11/2021. I started feeling a little "off" later in the evening. I woke up at 0300 with severe joint pain, headache and chills. Nausea started shortly afterwards. The joint pain was excruciating and it was very difficult to move. By 0330, I started vomiting. Vomiting continued until approximately 0745. I felt dehydrated but was not able to hold down any water. I contacted the Nurse Advice line and spoke to a nurse. She asked me a series of questions, all relating to signs indicative of an allergic reaction. I knew I was not experiencing a typical allergic reaction. But I was experiencing a bad reaction. Based on my responses to her questions, she did not recommend that I go an Urgent Care Clinic or see a Doctor. The severe joint pain continued through 02/14/2021. I started to feel better on 02/15/2021. Even though I did not experience an allergic reaction, given the severity of my joint pain and vomiting, I still feel it is important for what I did experience to be documented. Thank you.
lethargic; overly tired; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic) and FATIGUE (overly tired) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), ACETYLSALICYLIC ACID (BABY ASPIRIN), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), MULTIVITAMIN [VITAMINS NOS] and VITAMIN D3 for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced LETHARGY (lethargic) and FATIGUE (overly tired). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1000 mg once. On 28-Mar-2021, LETHARGY (lethargic) and FATIGUE (overly tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-060860 (Patient Link).
the patient reported having a mild headache, eye irritation, and sore throat; the patient reported having a mild headache, eye irritation, and sore throat; the patient reported having a mild headache, eye irritation, and sore throat; This spontaneous report was received from a physician via company representative,  referring to a 17-year-old male patient. The patient's pertinent medical history, concomitant therapies, as well as drug reactions or allergies were not reporter.   On an unknown date, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for complete the series (prophylaxis) and  sterile diluent (strength, dose, route of administration, and anatomical site of vaccination, lot number and expiration date were not reported). It was mention a used of sterile diluent (MERCK STERILE DILUENT).      On an unknown date, the patient reported having a mild headache, eye irritation and sore throat (Oropharyngeal pain) to a the physician. The outcome of headache, oropharyngeal pain and eye irritation was reported as resolved. The patient stated that he sought for medical attention and not treatment was given for the adverse events.  The causality assessment between the vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and the occurrence of the aforementioned events was not reported.
I have had decreased hearing and head congestion, ear feeling plugged, increased tinnitus, High pitch sound like buzzing electricity constantly, unable to tune it out. I also had severe case of vertigo with nausea and vomiting in January 2022.
chills; fever; first dose > 25 days ago; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever) and PRODUCT DOSE OMISSION ISSUE (first dose > 25 days ago) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (she had COVID really badly and it took her 5 weeks to get off and lost lot of her hair.) on 14-Jan-2021. Concurrent medical conditions included Antiphospholipid syndrome (Also known as Hughes disease, which is a sick blood disease) and Drug allergy (She does take warfarin since March 2019 because she is allergic to all heparin products).    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose > 25 days ago). On an unknown date, the patient experienced CHILLS (chills) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) for Chills and Fever, at an unspecified dose and frequency. On 27-Apr-2021, PRODUCT DOSE OMISSION ISSUE (first dose > 25 days ago) had resolved. At the time of the report, CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.
Pain in the lower side of the upper arm, towards the back side. It does not get any better. It feels like muscle pain. It is not at the site of injection.
delayed cutaneous hypersensitivity--red lesion, slightly swollen, itchy, some heat/tingling at site of injection
Patient was given the high dose influenza vaccination before his 65th birthday 10/01/20 (at 64 years 10 months).  Reporting as a precaution, no adverse effects to report.
Patient received HPV#3 and hep A #2 on 12/27/12. Since that time she has had excessive hair loss; abd pain and irregular menses. Parent requested report file.
Patient was sitting upright to receive her vaccines. As this was completed she became pale and I asked her if she was okay. She was unable to respond and appeared to have fainted. I lowered her to the table and as I was doing so she had a tonic clonic seizure. She was placed in the recovery position. Duration of seizure was approximately 30 seconds from onset to when she opened her eyes and was responsive. During this episode her skin was pale, lips gray, face was warm, extremities (hands) were cold and slightly clammy. 911 was called and she was monitored until their arrival. Vital signs: Pulse: 58, Respirations: Even, not labored, SPO2: 94, BP 100/48.  Mother reported that she had not eaten all day due to an "upset stomach". EMT's and police arrived within 5 minutes of call. Patient was kept laying down until their arrival and during that time she was talking with Mom and answering questions. Transported to Hospital in ambulance for further evaluation.
This case was considered medically important (OMIC). Information regarding Prevnar was received from a consumer regarding a male patient who experienced autism. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. It was reported that the patient was recently diagnosed with autism. Outcome is unknown. No additional information was available at the time of this report.
Sore arm; hives on the chest, neck, arm; Dizziness; feels like vertigo; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), URTICARIA (hives on the chest, neck, arm), DIZZINESS (Dizziness), VERTIGO (feels like vertigo) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 26-Mar-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 PAIN IN EXTREMITY (Sore arm), URTICARIA (hives on the chest, neck, arm), DIZZINESS (Dizziness), VERTIGO (feels like vertigo) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (Sore arm), URTICARIA (hives on the chest, neck, arm), DIZZINESS (Dizziness), VERTIGO (feels like vertigo) and NAUSEA (Nausea) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
My oxygen would drop when I would start moving around. It would drop into a dangerous rate, like below 85. This was just from moving from room to room in my house. I went to the doctor and they gave me steroids and antibiotics. I have breathing treatments that I take, but it still continued. I have been on oxygen at night before I got pneumonia, but now I need to be on it for 24 hours a day. I went to see my lung doctor and he added an inhaler called Asmanex. My doctor changed the medicine I was taking for RLS. I was put into respiratory therapy. The nurse ordered me a high frequency chest wall oscillation device. It vibrates my chest to clear the mucous. This has helped to where I don't have to use oxygen for 24 hours a day now. This lasted for about 6 months. I feel that if someone has had COVID, they shouldn't have to get the vaccine. The mandate is not right or fair. I don't feel safe, even though I have had two doses of the vaccine.
Dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there was a confusion between the expiration date printed in the carton and the expiration date when the code was scanned. No adverse events were reported. Vial did not undergo any temperature excursion. Vial was placed in refrigerator on 18-Nov-2021.  No treatment medications were reported.   This case was linked to MOD-2022-491837 (Patient Link).
PT REPORTED PALPITATIONS AND HEAD PRESSURE WITH A NEAR SYNCOPAL SENSATION 3 MINUNTES AFTER VACCINE ADMINISTRATION. PT ALSO REPORTED SOB AND MIDSTERNAL CHEST PRESSURE THAT RESOLVED BEFORE ENTERING OBSERVATION UNIT.  PT REPORTED BASELINE COUGH D/T HISTORY OF ALLERGIES. DENIES ANY FURTHER SX DISCHARGED ASYMTOMATIC WITH NEGATIVE ORTHOSTATICS LAST SET OF VITAL SIGNS : BP 139/88, HR 87, SPO2 99%, RESP 18
I received my Moderna booster COVID-19 vaccine. The site is red, swollen and really itchy. I haven't scratched at it or anything. My other two shots weren't like this one. My first 2 shots were fine. This one however is very different. The round spot is the size of a quarter. I have taken a photo of it.
On 11/8/12 received flu shot and within few hrs developed rash all over body, flushed face and reported feeling ill, generally.
Information has been received from a registered nurse concerning a 20 year old female patient with no know drug allergies, no seasonal/environmental allergies and without birth defects and pre-existing medical conditions, who on 28-AUG-2008 was vaccinated with the first dose of VARIVAX (Oka/Merck) (Lot number 659722/1877U) IM in the right deltoid. On 21-OCT-2008, the patient went for the second dose of VARIVAX (Oka/Merck), she reported a "very small blister like rash" distal to right deltoid administration site of the first dose of VARIVAX (Oka/Merck) given on 28-AUG-2008. The patient reported this reaction to the primary care physician when she noticed the rash on 29-AUG-2008 early in the morning (previously reported on the same day), and no treatment was received. The lesions lasted three days. On 03-SEP-2008, the patient recovered. The registered nurse consulted with the certified registered nurse practitioner (immediate supervisor) and the second dose of VARIVAX (Oka/Merck) was not given. Titers drawn indicated positive immunity (1.3). No further information is available.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 02-MAR-2012, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 10-AUG-2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
I received my Pfizer booster on 20Nov2021. The following Saturday I started to have chest pain on my left side whenever I would take a deep breath. On Sunday the pain increased so I went to the ER. They performed a CT scan and found multiple blood clots in both lungs, worse on the right side. Follow up with PCP on 29Nov2021 and he stated that there no risk factors indicating blood clots from previous labs performed over the past 3 years.
Fever, Rash, Moderate lymphadenopathy, pain and redness or left axilla Narrative:
Red raised welt/rash area on left upper arm with itching developed 6 days after vaccine.  Treated with Benadryl and if develops fever, chills, ha will treat with Keflex.
Transient ischemic attack; A report was received from a consumer concerning a 50 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed a TIA (Transient ischemic attack).   The patient's medical history was not provided. The patient current condition included ulcerative colitis, blood pressure, cholesterol and acid reflux. No relevant concomitant medications were reported.   On 29 Dec 2020, approximately twelve days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 026L20A) intramuscularly for prophylaxis of COVID-19 infection.   The patient experienced a TIA on 10 Jan 2021. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not provided .   The outcome of the event TIA was unknown.
Redness and swelling at injection site, Headache, chill, muscle ache, tired feeling. Symptoms started on day 2 after vaccination.
3 hrs after booster (3rd shot) @ 1:15pm HR 130 taken manually at carotid, tachycardia. Relaxed, deep breathing; HR slowed and BP returned to normal after 15 minutes. I didn't call Dr. or seek medical treatment at that time. 5 days later Wednesday 10/20 at 3:55pm  tachycardia again with BP of 164/104 HR 97, 98. I called my clinic and RN told me to report to ER. I arrived about 4:30-5:00pm, was admitted gave urine and blood sample.
Information has been received from a pharmacist referring to an adult patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. In 2009 (reported as "6 or 7 years ago"), the patient was vaccinated with an unspecified hepatitis A vaccine (manufacturer unknown) (dose, route, lot # and expiration date not reported). On 01-SEP-2016, the patient was in the office to receive a booster dose of the Hepatitis A vaccine in which VAQTA (dose, route, lot # and expiration date not reported) was going to be administered as the booster dose, which was outside of the dosage recommendations in the VAQTA prescribing information. No adverse effect was reported. Additional information has been requested.
Tiredness; Headache; down to neck; up to one side of head by right eye; Headache; down to neck; up to one side of head by right eye; Joint pain; Fever; Did not feel well; Swelling of throat on one side; Heart Racing; Dizziness; Weakness; Legs started hurting; sensation like something was going through veins; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A 59-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, batch/lot number: EN6207, Expiry date: unknown) via an unspecified route of administration, administered in arm left on 01Apr2021 as DOSE 1, SINGLE for COVID 19 immunization. The patient's medical history included on 11Mar2021 patient had surgery to remove a plate and stress from her lower ankle and foot. Concomitant medications were not reported. She did not take any other vaccine in four weeks prior COVID -19 vaccine. The patient got the vaccine because she knew that it had opened up for her age range. The patient wanted to able to go around her parents who are older and her grandmother who was 101 years old. The patient explained that she heard from people that some vaccine recipients were getting a placebo instead of the actual vaccine. She asked to validate the information. On 14Apr2021, the patient experienced tiredness, headache, down to neck up to one side of head by right eye, joint pain, fever, did not feel well, swelling of throat on one side, suddenly and severely, twice within a few minutes could barely talk or swallow, hear racing, dizziness, weakness, legs started hurting, had sensation like something was going through veins, going up legs to arms. The patient has been treated with pain medicine for her headaches. The outcome of the event fever was resolved in Apr 2021 and outcome of the events tiredness, joint pain, headache, down to neck up to one side of head by right eye, swelling of throat on one side, heart racing, did not feel well, dizziness, weakness was not resolved, and outcome for legs started hurting, sensation like something was going through veins was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.