chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm/ Feels Someone Pinching me; feels like there is tourniquet thing applied to my arm; Big red rash around the site; it is still swollen; Big red rash around the site; it is still swollen; Big red rash around the site; it is still swollen; Big Headache; Have Lot of Thirst; tongue often feel very harsh, my tongue feels dry; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm, administration date 24Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Vaccine Allergy" (unspecified if ongoing); "allergy to sting wasp" (unspecified if ongoing), notes: reaction for wasp sting,had strong reaction and face swollen. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm/ Feels Someone Pinching me; feels like there is tourniquet thing applied to my arm"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE RASH (non-serious), VACCINATION SITE SWELLING (non-serious), outcome "unknown" and all described as "Big red rash around the site; it is still swollen"; HEADACHE (non-serious), outcome "unknown", described as "Big Headache"; THIRST (non-serious), outcome "unknown", described as "Have Lot of Thirst"; TONGUE DRY (non-serious), outcome "unknown", described as "tongue often feel very harsh, my tongue feels dry"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue".  Additional information: The patient was allergic to vaccine and allergic to stings wasp and mentioned that should be careful for 2 nd dose. Patient don't know  that the symptom (had a lot of thirst and my tongue often feel very harsh, my tongue feels dry) which is related or not.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received the first dose of Moderna when he was 17. No adverse events or reactions was reported by the patient.
Information has been received from a registered nurse concerning an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # K002916, expiry date: 26-FEB-2016, dose and route unknown). The temperature excursion for VARIVAX (Merck) was supported with in-house stability data. No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
pt recvd vax 18MAR95 & 10 mins later mom noticed red flat blotches on lt cheek & lt thigh & @ site; pt given DPH;
Starting March 27 I developed a migraine and didn't go away until around May 19. It was extremely painful so I had to contact a healthcare provider and was prescribed a muscle relaxant but it didn't do anything so I decided to go to the Emergency Room and they did an MRI and they weren't find anything unusual so I had to go to a neurologist to have it checked. I have recovered from the migraines since then, after 3 months of continuous migraine pain.
Headache; A report was received from a consumer 79 year old, male patient was participating in a program and experienced headache No relevant concomitant medications were reported.   While participating in this program, and preceding this event, the patient experienced the serious adverse event of special interest of headache (MOD-2021-06313) Approximately 2 weeks a go prior to the onset of the event(s), the patient received their first of two planned doses of mRNA-1273 ([LOT/BATCH # 027L20A ]) intramuscularly  for prophylaxis of COVID-19 infection.   Patient received 1st shot of Moderna COVID Vaccine few weeks ago, may be 2 weeks a go but he does not remember the date and he has headache from the day of injection. Patient  enquired can he take aspirin as he knows aspirin will causes low B.P. No treatment information was provided. Consent to FU with him and his HCP.
On 1/17/2021 at 4:35 am resident found apneic and pulseless, at 4:40am death confirmed
palpitations, dizziness, vertigo, eye twitching, high blood pressure (150/100)
Information has been received from a Registered Nurse during a temperature excursion call, concerning a "child" patient who in "summer 2009" "within 24 hours of their birth" (approximately June 2009), was vaccinated with a 0.5 ml dose of RECOMBIVAX HB (manufacturer unknown) (route and lot# unspecified). Concomitant therapy included hepatitis B immune globulin. The Nurse reported she was aware of a child who was not diagnosed with hepatitis B antigen positive until around one year of age. They believed the child contracted hepatitis B from her mother prenatally but the child has been hepatitis B immune globulin (HBIG) and a dose of RECOMBIVAX HB (manufacturer unknown) within 24 hours of their birth. The patient was given unspecified treatment for this event. The Nurse was questioning if this might be a vaccine failure or a case of improperly stored vaccine being administered. The patient sought unspecified medical attention. At the time of the report patient's outcome was not reported. Additional information has been requested.
D68.9 ABNL UTERINE BLEEDING DUE TO COAGULOPATHY 2/19/2022 HX OF CARDIOVERSION I26.99 ACUTE PULMONARY EMBOLISM 2/23/2022 HX OF CARDIOVERSION J96.00 ACUTE RESPIRATORY FAILURE 1/11/2022 HX OF CARDIOVERSION J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 2/23/2022 HX OF CARDIOVERSION J96.91 HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 2/23/2022 HX OF CARDIOVERSION D68.9 ABNL UTERINE BLEEDING DUE TO COAGULOPATHY 2/19/2022 ATRIAL FIBRILLATION, UNSPECIFIED I26.99 ACUTE PULMONARY EMBOLISM 2/23/2022 ATRIAL FIBRILLATION, UNSPECIFIED J96.00 ACUTE RESPIRATORY FAILURE 1/11/2022 ATRIAL FIBRILLATION, UNSPECIFIED J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 2/23/2022 ATRIAL FIBRILLATION, UNSPECIFIED J96.91 HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 2/23/2022 ATRIAL FIBRILLATION, UNSPECIFIED D68.9 ABNL UTERINE BLEEDING DUE TO COAGULOPATHY 2/19/2022 UNSPECIFIED ANXIETY I26.99 ACUTE PULMONARY EMBOLISM 2/23/2022 UNSPECIFIED ANXIETY J96.00 ACUTE RESPIRATORY FAILURE 1/11/2022 UNSPECIFIED ANXIETY J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 2/23/2022 UNSPECIFIED ANXIETY J96.91 HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 2/23/2022 UNSPECIFIED ANXIETY D68.9 ABNL UTERINE BLEEDING DUE TO COAGULOPATHY 2/19/2022 ACUTE RESPIRATORY FAILURE I26.99 ACUTE PULMONARY EMBOLISM 2/23/2022 ACUTE RESPIRATORY FAILURE J96.00 ACUTE RESPIRATORY FAILURE 1/11/2022 ACUTE RESPIRATORY FAILURE J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 2/23/2022 ACUTE RESPIRATORY FAILURE J96.91 HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 2/23/2022 ACUTE RESPIRATORY FAILURE
Received Flu Vaccine on Oct. 10, 2008. 5 days later began fatigue which progressed to anaphylaxis, episode 1 on October. Received corticoteroids. Episode 2 anaphylaxis occurred Nov 5. Serious immune system overdrive. Caused first flare of either SLE or RA - tests confirmed +RF -. 5/8/09 - Medical records received DOS 10/30/08 to 1/22/09 FINAL DIAGNOSIS: Recurrent urticaria, migraine-like experience Neurological consult DOS 12/5/09: Urticaria associated with anaphylaxis. Nausea and photosensitivity. On this date PE WNL. Rheumatology consult DOS 1/8/09-1/22/09: C/O Blurred vision. Tingling in arms and feet. Anxiety, panic episode. Fullness and swelling in the supraclavicular area. Pseudocholinesterase deficiency. PE WNL.   5/11/09 - ED records recieved DOS 10/30/09.   FINAL DIAGNOSIS: Allergy Headache, itchy patches on right shoulder and left forearm. Lightheadedness. Small open lesions on upper back and neck. Double vision right eye. Advise cardiology and neurology consults.
No adverse event; 12 month old patient was administered an expired dose of VAQTA; This spontaneous report was received from a nurse, referring to a 12-month-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent condition, drug allergies/reactions and concomitant medication was not provided. On 26-NOV-2019, the patient was vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA) (strength, dose, schedule, anatomical location and route of administration was not reported) (lot# R034340 and expiry date: 23-NOV-2019) for prophylaxis (expired product administered). There was no associated product quality complaint. No additional adverse events were reported.
Adverse effect of other vaccines and biological substances, initial encounter on 2023-05-08.
According to parents child "was burning up" and had seizure activity- described tonic and clonic behavior with vomiting at 7 pm on day he received vaccines at 10:00 am. Parents had been advised to give child Tylenol at regular intervals.  02/07/2007: Hospital H&P forwarded from reporter for overnight hospital stay. Parents report that their 4 year old  had an episode of tonic/clonic seizure-like activity on the evening of his vax, preceded by eyes rolling back and becoming tense. Child was brought to the ER vomiting, which persisted during the ER visit.  He had some congestion and coughing as well.  Temp. was 100.9'F. PE: Normal except except mild hypotonia, and a mildly ataxic gait. DX:  Seizure, probably seizure with fever as opposed to febrile seizure. Questionable reaction to immunizations.  More probably intercurrent febrile illness.
3 to 5 days later patient get very sick; Initial information received regarding an unsolicited valid non-serious case from a consumer (patient) from via social media and transmitted to Sanofi on 29-Oct-2020.  This case involves unknown age female patient got very sick 3 to 5 days later after taking INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations, concomitant medications 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 unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got very sick (malaise) three to five days following the administration of INFLUENZA VACCINE.  Final diagnosis was malaise.   It was not reported if the patient received a corrective treatment.  Event outcome was reported as Unknown for malaise.  Lot number was unavailable for this case.
My arm got very hot and painful to the touch for about 3 days after the vaccine. On 04/29 I woke up at 2 AM and I had trouble walking and I was very dizzy. I sat down and it felt I was having a stroke, I lost control of the left side of my body. My husband called an ambulance and it got to the point where I was having trouble speaking. I started repeating words and unable to stop. I went to the ER 04/29/2021 and they did a number of tests that determined it was not a stroke and I was admitted into the hospital. Initially I had no control of L or R legs and my muscles started spasming in both legs. I was not able to move legs at all. The Doctors would lift my legs and they would just fall. Approximately 8 AM  on April 29 I started being able to walk short distances with assistance. I worked with a Physical therapist about 9:30 am and was able to climb 3 steps very slowly leading with my left foot, and not being able to lift my right foot. I slowly started regained control of L arm by 7 AM on April 29.. The weakness on the right side remained until 06/01/2021 when I finally regained full strength back in R leg. I did PT for 4 weeks 2x a week leading up to finally having full control again. I've had issues with tremors in all four extremities pretty consistently since  April 29. I do still have the tremors.
2 days after MENACTRA L deltoid of pt developed itching erythema of site. Pt seen 8/12/09  noted ~ 8 cm area of erythema no warmth.
This spontaneous report as received from a registered nurse via a company representative refers to a child patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II (Lot#, dose and route were not provided). The child experienced a high fever after being vaccinated with M-M-R II. The outcome of the event is unknown. It was unspecified if the patient had sought medical attention. Additional information is not expected.
HEADACHE; RED SPOTS / RASH IN LEFT ARM; KNOT/LUMP IN LEFT LEG; SWOLLEN LEFT ARM; TENDER LEFT ARM; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included deteriorating disc disease (c4 and c5 in spine), pain in hand, tingling in hand, neuropathy, and varicose veins.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: 20/JUN/2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, fosinopril, ibuprofen, metformin, and simvastatin.  On APR-2021, the subject experienced knot/lump in left leg. On APR-2021, the subject experienced swollen left arm. On APR-2021, the subject experienced tender left arm. On 19-APR-2021, the subject experienced red spots / rash in left arm. On 20-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from knot/lump in left leg, tender left arm, red spots / rash in left arm, and headache on APR-2021, and had not recovered from swollen left arm. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures, as the case was assessed as non-serious.
Swollen lymph nodes, fatigue, head ache, muscle cramps. No treatment. Duration of 3 days.   Chest pain, fatigue. No treatment. Duration 40 days and ongoing.
Headache, Myalgia, Fever, Tachypnea, neck pain, achy, fever 100.5, shakes/chills, sore throat, heart rate increased (102), cough, nasal congestion. Narrative:
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted while walking in store.  She was found on the floor but she was still conscious. She described her symptoms are blurry vision and head spinning. She noted that she was afraid of needles and was very nervous for the appointment. She was given gatorade to hydrate and was under watch for around 20 min. She felt better and left the pharmacy on her own.
13Jan98 lab eval revealed "no rubella immunity". 30Jan98 pt recv 1st dose vax. Pt devel "fusion both knees.Knees painful w/fluid.Arthralgia & edema right wrist,right ankle & 4th & 5th fingers right hand. Devel same sx left side. "Pins/needl
received first dose of Moderna Covid-19 and received second dose of Pfizer Covid-19 vaccine.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (received first dose of Moderna Covid-19 and received second dose of Pfizer Covid-19 vaccine.) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and EW0171) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced WRONG PRODUCT ADMINISTERED (received first dose of Moderna Covid-19 and received second dose of Pfizer Covid-19 vaccine.). At the time of the report, WRONG PRODUCT ADMINISTERED (received first dose of Moderna Covid-19 and received second dose of Pfizer Covid-19 vaccine.) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    No concomitant medications were given No treatment information was provided
Information has been received from a registered nurse concerning a 7 year old female with no known medical history or allergies who on 4/18/02 was vaccinated SC in the right thigh with a first dose of varicella virus vaccine live (lot # 638816/1236L). Concomitant vaccination on the same day included an IM fifth dose in the left thigh of diphtheria toxoid (+) pertussis acellular vaccine (+) tetanus toxoid (lot U0542BA) and a SC fourth dose in the right thigh of poliovirus vaccine inactivated (lot # U0344). There was no other concomitant medication. There was no illness at the time of vaccination. On 9/16/04, the patient experienced a cluster of about 10 to 12 lesions on her forehead and also some on her legs, with a total of 36. It was reported that she was afebrile. On 9/17/04, the patient was seen in the office and no treatment was required. A product quality complaint was not involved. Follow up information from the registered nurse indicated that on 9/17/04 the patient had about 36 chicken pox lesions and subsequently recovered. No diagnostic laboratory tests were performed. The patient had no adverse experiences following prior vaccination. No further information is expected.
Dose administered past the 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date) in a 22-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided
THE PATIENT WAS HERE FOR HIS PRIMARY SERIES MONOVALENT 2ND DOSE FOR COVID 19.  THE PATIENT WAS GIVEN A BIVALENT PFIZER BOOSTER INSTEAD. THE PATIENT HAD NO REACTION WHILE IN THE OFFICE.  CALLED CDC TO REPORT THE ADMINISTRATION ERROR AND THE REPRESENTATIVE DID EMAIL ME INFORMATION AND ADVISED ME TO REPORT A VAERS.  WE HAVE ATTEMPTED TO CONTACT THE PATIENT'S FATHER SEVERAL TIMES AND HAVE NOT BEEN SUCCESSFUL.
Patient received shots Friday 05/23/2003. Sunday 103 temp (record not available).  Follow up 07/31/2003: "The chart is gone and I do not have."
Pt did not have a reaction to the vaccine but she is less than the recommended age of 4 years old
Small itch rash around injection site of MMRV vaccine. Counseled by Dr. Rash resolved in 2 hours.
Vaccine administered at 11:00 am at 11:10 client reported throat and tongue tingling, dizziness and difficulty breathing. Administered 1 mg epinephrine. EMS was called and transported client to the hospital where he was admitted under observation.
Patient came to office to receive MENVEO & #2 VARIVAX. Very anxious, past history of fainting. Fainted seconds after receiving 2nd immunization.
About 3 days after the shot, blisters appeared on my right arm - from wrist to shoulder - and three on upper right side of my back - there was a cluster around the elbow. I saw the doctor, she gave a medication tablet - blue & a white one - I don't know the names are.
I've had a constant buzzing in my ears which appears to be getting louder.  I am highly sensitive to noise now, especially of a certain pitch because it makes the buzzing get louder. I don't listen to music as much now, and if so, have to forward past songs that have that certain pitch, or percussion instruments that amplify the already loud buzzing.  I've stopped singing with my husband for the most part because it has become irritating to the buzzing.  At first I thought it would go away with time, but now I'm ready to seek treatment.
Sore arm on day post vaccination. Two days post vaccination she developed a red rash under left breast and in the groin area. The areas were sweating profusely. Her arthritis also flared up and she could not go to work for two days she was so sore all over.
recieved 1 dose and i have been sick for 5 weeks now; shortness of breath; left hand is really  weak; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (recieved 1 dose and i have been sick for 5 weeks now), DYSPNEA (shortness of breath), MUSCULAR WEAKNESS (left hand is really  weak) and CHILLS (Chills) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (recieved 1 dose and i have been sick for 5 weeks now), DYSPNEA (shortness of breath), MUSCULAR WEAKNESS (left hand is really  weak) and CHILLS (Chills). At the time of the report, ILLNESS (recieved 1 dose and i have been sick for 5 weeks now), DYSPNEA (shortness of breath), MUSCULAR WEAKNESS (left hand is really  weak) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. No relevant concomitant medications reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Aug-2021: Follow up document received contains no new information
Positive for covid-19.; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Positive for covid-19.) 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 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced COVID-19 (Positive for covid-19.). At the time of the report, COVID-19 (Positive for covid-19.) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     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.   Concomitant medications were not provided.  Treatment information was not provided.  HCP called to get guidance on whether a covid-19 positive patient could received the second dose of the Moderna vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: NNI
This spontaneous report was received from a pharmacist refers to a 31 year old patient. On 03-OCT-2013, the patient was vaccinated with an expired dose of 0.5ml M-M-R II, (lot number 1759AA, expired on 12-JUL-2013), subcutaneous. No adverse effects were reported. The patient did not seek medical attention. The pharmacist enquired regarding revaccination recommendation post administration of expired M-M-R II. Additional information has been requested.
Patient first experienced a lot of fatigue. She said she thought she was getting the flu. On 9/27 she woke-up with a rash on her arm. Rash is warm, approx. 4 inches, no welp is present. I advised her to take BENADRYL and to let me know if it got worse. She said she has never had a reaction to her flu shot before.
Patient started with a severe headache in the evening. By the next morning he had a fever of 102 degrees that lasted for 36 hours. His headache was very bad, his joints and muscles were very painful. He started vomiting in the morning and had no appetite and continued to vomit for 24 hours. Ibuprofen helped a little but did not fully relieve symptoms.
Near Fainting       Heart rate 52 pale poor cap refill, dizzy and nausea.