chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DEATH; BLOOD CLOT; This spontaneous report received from a health care professional concerned a 66 year old White and not Hispanic or Latino female. Initial information received from the health care professional on 05-MAY-2021 was processed with additional information obtained from live follow up with health care professional on 06-MAY-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, diabetes, high cholesterol, non smoker, non alcohol user and other pre-existing medical conditions included no known allergies, no drug abuse or illicit drug use. Lab work was done 3-4 months ago, the results of which were unavailable. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: Unknown) dose was not reported, 1 total, administered on 10-APR-2021 possibly left arm for prophylactic vaccination. Unspecified concomitant medications were reported. On 28-APR-2021, the patient developed right leg pain and right leg swelling also began around this time as well. On 04-MAY-2021, the patient died from blood clot. An autopsy was not performed. The reporter stated that the patient's death was related to Janssen covid-19 vaccination and blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of blood clot on 04-MAY-2021. This report was serious (Death).; Sender's Comments: V0:20210509157-JANSSEN COVID-19 VACCINE- Death, blood clot - These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.; Reported Cause(s) of Death: BLOOD CLOT
-Large swollen hot area the size of a small grapefruit at site of injection.  -Itching feet, arms, chest - headache  - nausea  - fatigue
Pt recvd vax & 24 hrs later devel moderate ipsilateral adenopathy;
Scratchy throat; Several mouth sores; Flare up in eczema outbreaks; This is a spontaneous report from a contactable consumer (patient). A 44-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number was not reported) via an unspecified route of administration on 17May2021 at 09:00 in right arm as a single dose for covid-19 immunization. Medical history, concomitant medications received within 2 weeks of vaccination were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine) on 23Apr2021 at 09:00 for COVID-19 immunization. On 24May2021 at 11:45, after the second dose the patient developed scratchy throat, several mouth sores and her eczema outbreaks flared up. Patient was not hospitalized for the events. The patient did not receive any treatment. Device date was reported as 30May2021. The outcome of all the events at the time of last observation was resolving.   No follow-up attempts are possible. No further information is expected.
Noticed about one hour after vaccines that she had tiny  blisters on her lips. Not sure if related to vaccines or from stick injury from sewing needle. Needle was found in new garment purchased from store and it was manufactered in another country. Needle stick happened on December 4th, 2007. Relates symptoms could be from stress of the needle stick.
Patient got the expired Covid-19 vaccine (vaccine expired on 02/12/22). No ADEs is reported. Called Pfizer medical rep and she said there is new data that Covid-19 vaccine (purple cap) is stable in the fridge for 45 days. Advised patient to call doctor if the new data is acceptable. If not, revaccination is required.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown dates in 2017 (reported as beginning sometime in January 2017), the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M031807, expiration date: 02-APR-2018) (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of  93.04 degrees Fahrenheit for 8 hours and 42 minutes on 24-JAN-2017. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA012513: US-009507513-1703USA011060: US-009507513-1703USA012512:
swelling from her elbow to her shoulder; red; hot; hard; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling from her elbow to her shoulder), ERYTHEMA (red), VACCINATION SITE WARMTH (hot) and VACCINATION SITE INDURATION (hard) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013LZ0A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced SWELLING (swelling from her elbow to her shoulder), ERYTHEMA (red), VACCINATION SITE WARMTH (hot) and VACCINATION SITE INDURATION (hard). At the time of the report, SWELLING (swelling from her elbow to her shoulder), ERYTHEMA (red), VACCINATION SITE WARMTH (hot) and VACCINATION SITE INDURATION (hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The pharmacist advised the patient to consult her doctor and discuss if it would be ok to take corticosteroids after the second shot.
Developed "terrible" headache, with body aches, feeling "out of it" and congested sinuses after receiving flu vaccine that resolved over 3 days.
Little pain in the arm of the injection; Nausea; Diarrhea; Loss of appetite; Stomach upset; Body aches; Very fatigued; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DECREASED APPETITE (Loss of appetite), ABDOMINAL DISCOMFORT (Stomach upset), PAIN (Body aches) and NAUSEA (Nausea) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high and High cholesterol. Concomitant products included VITAMINS NOS for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN (Body aches), FATIGUE (Very fatigued) and MYALGIA (Muscle pain). On 09-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), DECREASED APPETITE (Loss of appetite), ABDOMINAL DISCOMFORT (Stomach upset) and NAUSEA (Nausea). On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (Little pain in the arm of the injection). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 09-Feb-2021, ABDOMINAL DISCOMFORT (Stomach upset), PAIN (Body aches), FATIGUE (Very fatigued) and MYALGIA (Muscle pain) had resolved. On 10-Feb-2021, DIARRHOEA (Diarrhea), DECREASED APPETITE (Loss of appetite) and NAUSEA (Nausea) had resolved. At the time of the report, VACCINATION SITE PAIN (Little pain in the arm of the injection) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include high blood pressure and high cholesterol medications.
Information has been received from a health professional concerning a 6 year old female with no past medical history and no known drug allergies who on 07Dec1998 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy that day included a dose of Hib conj vaccine (manufacturer unknown) and measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). There were no other concomitant medication. On 29Dec2003 the pt developed 35 pox. The pt experienced itching but no fever and her mother noted that she was active. No treatment was provided. Unspecified medical attention was sought. There was no product quality complaint. No laboratory or diagnostic tests were performed. Additional information has been requested.
5 minutes after taking the MCV4 vaccine,while patient was leaving, she sat down in the corridor saying she is blurry and feeling weak in the legs. Patient was brought in the room,made to lie down on the table by MA.I was called in the room to check her. Neurologic exam normal. Observed for 1/2 hr. Pt continued to cry.  Patient was also examined by associate Dr.,Normal Neurologic exam. Patient given some crackers to eat. Pt calmed down after sometime. Walked out of the office smiling with no complains of leg weakness/blurry vision. Mom instructed to keep her home and watch her closely.
Patient reported that her arm was very sore and it hurt to lift her arm, she reported no breathing issues, no redness or swelling on the arm, on arm weakness (just extremely sore).
24 hours follow vaccination patient experienced body aches, fever, headache, and local soreness. 5 days following vaccination patient experienced vomiting, and dizziness, headache and confusion.
Stiffness throughout body; Pain at injection site; Low grade fever; Chills; Nausea; Fatigue; Headache; General muscle pain; Joint Pain; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness throughout body), VACCINATION SITE PAIN (Pain at injection site), PYREXIA (Low grade fever), CHILLS (Chills) and NAUSEA (Nausea) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A and 049C21CA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Influenza (first dose on left arm) on 09-Sep-2021. Past adverse reactions to the above products included No adverse event with Influenza.   On 16-Jul-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021 at 3:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 29-Sep-2021 at 7:00 AM, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness throughout body), VACCINATION SITE PAIN (Pain at injection site), PYREXIA (Low grade fever), CHILLS (Chills), NAUSEA (Nausea), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (General muscle pain) and ARTHRALGIA (Joint Pain). The patient was treated with IBUPROFEN at an unspecified dose and frequency and ACETAMINOPHEN at an unspecified dose and frequency. On 28-Sep-2021 at 3:00 PM, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. On 01-Oct-2021, MUSCULOSKELETAL STIFFNESS (Stiffness throughout body), VACCINATION SITE PAIN (Pain at injection site), PYREXIA (Low grade fever), CHILLS (Chills), NAUSEA (Nausea), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (General muscle pain) and ARTHRALGIA (Joint Pain) had resolved.            No concomitant medication was reported by reporter.  Patients symptoms were not as severe as from first dose. Symptoms recurred lasting 2 to 3 days.   This case was linked to MOD-2021-262783 (Patient Link).
fever of 102.2 and seizure, rash all over body for 3 days and still there, fever lasted 3 days.
Severe body aches. Headache. Chills. Fever of 103.9. Vomiting. Sore throat. Swollen glands.
This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (Sneezing non stop), LACRIMATION INCREASED (Watery eyes), NASAL CONGESTION (Congested nose), RHINITIS (Feels like rhinitis) and RASH PRURITIC (Itchy rash, like hives in their two forearms) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 014M20A and D20RPC8) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, VITAMINS NOS, NUTRAFOL and MELATONIN for an unknown indication.On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced SNEEZING (Sneezing non stop), LACRIMATION INCREASED (Watery eyes), NASAL CONGESTION (Congested nose), RHINITIS (Feels like rhinitis), RASH PRURITIC (Itchy rash, like hives in their two forearms), URTICARIA (Like hives in their two forearms) and RASH (Sometimes the rash appears on their face). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) on 24-Nov-2021 for Sneezing, at a dose of 1 dosage form. At the time of the report, SNEEZING (Sneezing non stop), LACRIMATION INCREASED (Watery eyes), NASAL CONGESTION (Congested nose), RHINITIS (Feels like rhinitis), RASH PRURITIC (Itchy rash, like hives in their two forearms), URTICARIA (Like hives in their two forearms) and RASH (Sometimes the rash appears on their face) outcome was unknown.
ACHES; RUN DOWN; SORE ARM; This spontaneous report received from a patient via a company representative concerned a female 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: Unknown) dose was not reported, administered on //2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up to request batch number. No concomitant medications were reported.  On //2021, the subject experienced aches. On //2021, the subject experienced run down. On //2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from run down, sore arm and aches. This report was non-serious.
Adverse Event: Guillain Barre Syndrome - symptoms - eight days after administration of the SHINGRIX vaccine, the patient had gradual weakening of bilateral lower extremities in a proximal to distal distribution. This weakness progressed to inability to ambulate on one's own, falling, and loss of sensation of the distal four toes bilaterally. Strength was diminished to be 3/5 in bilateral lower extremities compared to baseline of 5/5. No symptoms in upper extremities or Cranial Nerve distribution. Additionally, patient complained of decreased anal sphincter activity, but denies incontinence. Patient denied shortness of breath, difficulty breathing, and cough. Treatment: IVIG. Outcome: cessation of symptom progression. Patient still had decreased strength and required intense outpatient Physical Therapy 5 times a week.
Varicella vaccine left thigh SC 12/30/03. 1/22/04 Fever 102.4F. 1/23/04 vesicles developed, left scrotum to pubic, chin, abdomen on back and one vesicle right buccal mucosa. All typical of chicken pox.
After getting the shot, patient sat down on the floor while the other family member was getting the shot. When I was giving the shot to the family member, felt like she was going to pass out, so asked her if she was ok, she said yes. But then I went near the patient to hold her as she almost passed out. lied down in my lap for a minute and then she was back to normal. asked her to sit, gave her water bottle and watched her for few minutes. After that asked her to sit outside the immunization room in front of pharmacy, she was able to walk by herself, waited for 15 minutes and then left the store
Severe stomach cramping; diarrhea; dizzy; nausea; cold clammy pale skin; cold clammy pale skin; sweating profusely; very low body temp; rapid pulse; shaking; This is a spontaneous report from a contactable consumer who reported for herself. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, via an unspecified route of administration in the left arm on 02Feb2021 04:00 PM at a single dose for covid-19 immunisation. Medical history included obesity. Patient was not pregnant at the time of vaccination. The patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. On 02Feb2021 at 10:00 PM (6 hours after vaccine was given),  the patient experienced severe stomach cramping, diarrhea, dizzy, nausea, cold clammy pale skin, sweating profusely, very low body temp, rapid pulse, and shaking. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.
Expired vaccine(Exp: 04/28/2021) was administered on 04/29/2021
vomiting; diarrhea; shaking; numb/ tingling hands and feet; numb/ tingling hands and feet; chills; aches; Other vaccine same date vaccine date 20Oct2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Oct2021 13:30 (Batch/Lot number: unknown) at the age of 35 years as dose 3 (booster), single and administered in arm left, administration date 18Mar2021 14:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administered in arm right, administration date 20Oct2021 (Batch/Lot number: unknown) as dose 1, single. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Known allergies: amoxicillin, reaction(s): "known allergies: Amoxicillin". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 25Feb2021, when the patient was 34 years old, for Covid-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 20Oct2021, outcome "unknown", described as "Other vaccine same date vaccine date 20Oct2021"; VOMITING (non-serious), outcome "not recovered", described as "vomiting"; DIARRHOEA (non-serious), outcome "not recovered", described as "diarrhea"; TREMOR (non-serious), outcome "not recovered", described as "shaking"; HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious), outcome "not recovered" and all described as "numb/ tingling hands and feet"; CHILLS (non-serious), outcome "not recovered", described as "chills"; PAIN (non-serious), outcome "not recovered", described as "aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vomiting, diarrhoea, tremor, hypoaesthesia, paraesthesia, chills, pain.  Additional information: The patient did not receive any other medications within two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 (covid test name post vaccination: Bianox).  Follow-up attempts completed. No further information is expected.The lot/batch number is not available despite the follow-up attempts made.
soreness of the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 22 year-old male patient received bnt162b2 (BNT162B2), administration date 17Sep2021 (Lot number: 30130BA) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Overweight" (unspecified if ongoing), notes: He is overweight, he weighs she thinks 230lbs, caller states that they are working on his weight. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "soreness of the arm". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts are completed. No further information is expected.
I've been experiencing a lot of vaginal discharge that I haven't had before. I'm also experiencing random cramping similar to the start of my period but my period isn't for 2 more weeks. Nothing else except the vaccine has changed in my day-to-day or my medication. I am not pregnant.
THE DOSE WAS GIVEN FROM A BOTTLE THAT WAS LEFT IN THE REFRIGERATOR OVERNIGHT, AND 5 HOURS AFTER THE 12 HOUR BEYOND USE TIME. WHEN REALIZED WE RECALLED THE PATIENT TO GIVE AN ADDITIONAL DOSE FROM A FRESHLY OPENED VIAL.
While in observation he began to get clammy and sweaty.  Vital signs were obtained which revealed elevated BP.  After several minutes, BP was reassessed and was still elevated.  Patient was AAOx3 and had no speech difficulties.   Patient reports that his baseline BP is 140/65. BP noted as 206/89.  ED notified and patient transferred via wheelchair to ED.
Received H1N1 Mist @ school clinic, developed fever, H/A and cough 48 hours after vaccine administered. 48 hours later, fever and H/A resolved. Continued to have cough and developed runny nose. 2/17/10 - presented to MD office still c/o runny nose and cough.
This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with an unspecified dose of GARDASIL (lot# unspecified) for human papillomavirus prevention. On an unspecified date after receiving the vaccine series, the patient discovered a bald spot on her head. The outcome of a bald spot on her head was unknown. Additional information has been requested.
trouble sleeping Wednesday noc r/t arm hurting (lt deltoid);went to MD 2MAY97 dx w/cellulitis w/probable staph & prescribed an ATB;
I have not had my period since getting the COVID 19 vaccine - moderna. Starting shakeing 2 hours after and broke out in sweats, couldnt sleep but short term affects have since stopped. I am concerned about my period stopping after receiving this.
Moderna COVID-19 Vaccine EUA About 18hrs after vaccine was received, I experienced diarrhea and loss of appetite. Continued to experience loss of appetite and have bouts of diarrhea about every 3-4 hours throughout that day. 2nd day after the vaccine (1/13/21)  2:15am  pain at the injection site was severe enough to wake me when I rolled over on that arm, then I had nausea and diarrhea and fell back asleep. Upon waking 8:15am, continued to have diarrhea and loss of appetite until evening of 1/13/21. Arm pain went away 1/14/21.
After 3 hours of receiving vaccine intense itching and redness (9/26) and blotchiness on upper arm & legs. Pt went to Urgent Care received Prednisone (5-day), ATARAX; saw Dermatologist (9/26) and received Prednisone (9-day), ATARAX, LIDEX cream; 2nd Dermatologist (10/7, 10/14, 10/21) continued ATARAX and LIDEX and other medications stopped except BENICAR - Symptoms have not improved over entire body.