chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Scatter brain; Incoherent; Brain fog; Lost his mind; Has no reflexes; Can't move but he can hear; He can't talk; This spontaneous case was reported by a consumer and describes the occurrence of THINKING ABNORMAL (Lost his mind), FEELING ABNORMAL (Scatter brain), INCOHERENT (Incoherent) and FEELING ABNORMAL (Brain fog) in a 66-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 25-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 25-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THINKING ABNORMAL (Lost his mind) (seriousness criterion hospitalization). On an unknown date, the patient experienced FEELING ABNORMAL (Scatter brain) (seriousness criterion hospitalization), INCOHERENT (Incoherent) (seriousness criterion hospitalization), FEELING ABNORMAL (Brain fog) (seriousness criterion hospitalization), AREFLEXIA (Has no reflexes), MOVEMENT DISORDER (Can't move but he can hear) and SPEECH DISORDER (He can't talk). At the time of the report, THINKING ABNORMAL (Lost his mind), FEELING ABNORMAL (Scatter brain), INCOHERENT (Incoherent), FEELING ABNORMAL (Brain fog), AREFLEXIA (Has no reflexes), MOVEMENT DISORDER (Can't move but he can hear) and SPEECH DISORDER (He can't talk) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided.  Reporter stated that the patient had been admitted to a total of 3 psychiatric hospitals and was currently there in the hospital. Reporter also stated that on 21-Apr-2021 the patient was acting normal for a total of 20 hours and then he started back acting weird.  Company Comment:  Very limited information regarding this events has been provided at this time. .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. Further information has been requested   This case was linked to US-MODERNATX, INC.-MOD-2021-089085, US-MODERNATX, INC.-MOD-2021-111101 (E2B Linked Report).; Sender's Comments: Very limited information regarding this events has been provided at this time. .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. Further information has been requested US-MODERNATX, INC.-MOD-2021-089085:MOD-2021-089085 Dose 1 case US-MODERNATX, INC.-MOD-2021-111101:cross link
muscles discomfort in arm; This case was reported by a consumer via interactive digital media and described the occurrence of muscle discomfort in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, several weeks after receiving Shingles vaccine, the patient experienced muscle discomfort. On an unknown date, the outcome of the muscle discomfort was recovered/resolved.   It was unknown if the reporter considered the muscle discomfort to be related to Shingles vaccine.  Additional information was provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received the Shingles shot a few weeks ago. The patient had no pain, just minor muscles discomfort in arm for 1 day. The patient would get the second shot in February (year unspecified). The patient further stated that get the shot and Shingles could be prevented. The follow-up would not possible as no contact details were available.
Every since the day that I got the 2nd dose of the GARDASIL shot, my skin has been itching. I did not take the third dose because of this reason. I have to take Zyrtec everyday. If I don't, I break out in hives and my skin itches so bad to he point of bleeding. I have reported this to doctors numerous times, and nothing has ever been done about it. I've just been told to continue taking Zyrtec. I was  patient, and I had the immunization through the OB/GYN department.
On February 18, about 6:00 pm, I felt so cold, shivering uncontrollably.  Bundled up in robe, and 2 afghans.  Low grade fever of 99.6.  Went to bed.  Fever must have been high during night according to husband.  Slept through it.  Following morning, felt washed out, ache around my eyes.  By 6:00 pm, no symptoms at all.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE EPILEPSY, UNSPECIFIED HYPOTENSION
Fatigue, chills 4/26-4/26 Injection site soreness 4/26-4/27 Swollen lymph nodes right under arm 4/27-ongoing
Information has been received from a physician referring to an unknown number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, on or after 01-APR-2016, the patient were vaccinated with improperly stores doses of VARIVAX (lot # L024253 with expiration date 01-JUL-2017, lot # L024256 with expiration date 01-JUL-2017, lot # L001328 with expiration date 13-JAN-2017, lot # L016123 with expiration date 06-MAY-2017; dose and route were not reported). It was reported that the vaccine was improperly stored at 35.47 Fahrenheit for 314 hours and 15 minutes. There was no previous excursion and data logger was involved. No adverse effect was reported. This is one of two reports received from the same reporter. Additional information has been requested.
100F fever; fatigue; muscle pain; chills; headache; eye pain; weakness; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient (patient was not pregnant at the time of vaccination) received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL3302, Expiration date: unknown), via an unspecified route of administration, administered in Arm Left on 09Feb2021 at 13:00 (age at vaccination was 57 years) as dose 2, single for COVID-19 immunization. The patient's medical history included covid-19 from an unknown date. The patient did not have any known allergies. The patient did not receive any concomitant medications or other medications in two weeks. The facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EX9231, Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 19Jan2021 at 14:00 (age at vaccination was 57 years) as dose 1, single for COVID-19 immunization. On 10Feb2021 at 08:00, the patient experienced 100F fever, fatigue, muscle pain, chills, headache, eye pain and weakness. No treatment was received for the adverse event. The patient underwent lab tests and procedures which included body temperature which showed 100 Fahrenheit result on Feb2021. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Cellulitis- injection site warm, red, positive induration spreading.  Low grade temp. Difficulty moving arm. ABX started.
No additional AE information; MMRII that had been reconstituted with expired diluent had been inadvertently administered to a patient; MMRII that had been reconstituted with expired diluent had been inadvertently administered to a patient; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.   On 30-MAR-2022, the patient was vaccinated inadvertently with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route, lot # and expiration date were not provided) that had been reconstituted with 1 dose of expired sterile diluent (lot #S025290, expiration date 20-MAR-2022) for prophylaxis (expired product administered, and product preparation error). The vaccine was not expired and did not experience any temperature excursions. The sterile diluent had not experienced any temperature excursions. No additional adverse event (AE) information.
After recommended monitoring time, Patient?s reaction to COVID-19 Vaccination: dizzy , lightheaded, probable vasovagal: was sent EMS to the ER.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 23-OCT-2008 the patient was vaccinated with the first dose of GARDASIL dose, route, lot number and expiration date not reported). The nurse stated that at the time of the report on 19-SEP-2013 (also reported as now) the patient was in the office to receive dose 2 of GARDASIL (route, dose, lot number and expiration date not provided) which would be late. No symptoms were reported. The patient's outcome was not provided. Additional information has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and conditions and concomitant medications were not reported. On 13-SEP-2016 and 14-SEP-2016, the patients were improperly stored vaccinated with PROQUAD (dosing details were not reported) (lot # M015698, expiry date: 26-SEP-2017) which was at a temperature of 11 degree Fahrenheit for a duration of 12 hours 35 minutes. No adverse effects were reported. There was no product quality complaint reported. Additional information has been requested.
Bladder infection; This spontaneous case was reported by a consumer and describes the occurrence of CYSTITIS (Bladder infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event.    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 CYSTITIS (Bladder infection). At the time of the report, CYSTITIS (Bladder infection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Caller got her first vaccine and is getting the second vaccine today at noon. She does not have a fever, but she has a bladder infection and is it ok to get vaccine today? Consent for Safety follow up
Collapsed -- full blackout -- next evening after 2nd vaccination. Recovered next day except for sprained foot.
A few hours after I got the shot I had flu-like symptoms. Headache, fever, nausea, chills, and vomiting. About 12 hours later my flu-like symptoms went away but my headache turned into a migraine. I have no history of migraines. I have been taking ibuprofen and tylenol but it has not been working. I currently still have the Migraine 48 hours after the shot.
April 25 I started with a drooped face on the right side, eyes, nose, and lips affected  - Diagnosed with Bells Palsy after stroke was ruled out. Treated with Prednisone and Valacyclovir 1GM. Symptoms improved very little after 12 days, Movement in face is slowly returning, but mot 100%. Taping eye closed to sleep.  Finished above medicines May 5. Then May 7 started with spasms/numbness in my lower back. Did nothing to cause this, had been taking it easy since Bells Palsy diagnosis.   Spasms, quivers in back with some numbness.
10 days p/vax pt devel lesions on legs 7 fever of 101;also lethargic dx w/erythema nodosum;PMD feels this could be r/t hep b vax;
Chest pain with EKG changes and elevated troponin - final diagnosis - myocarditis
pt recv vax 8DEC97 & 2wk later eyelid swelling & eyelash loss;
pt recvd vax 15NOV93 & by 16NOV93 w/in 24 hrs devel rash all over body even inside ears w/severe itching; took pt to ER;
Sore arm/ache starting 6/4/15. Rash at injection site started 6/9/15. Patient came into pharmacy on 6/10/15. Arm was red, slightly swollen and warm only at injection site. Marked area and advised patient to take BENADRYL, MOTRIN and ice. Will follow up 6/11/15.
Hospitalization: 4/2/2023 - 4/5/2023 Presentation to the ED: Past two weeks of elevated blood pressures, c/o weakness, shortness of breath, nausea. COVID + date: 4/2/2023 Treatment: did not require tx. asx.  Discharge to: home.  006M20A 2/13/2021 001B21A 3/13/2021 017F21A 10/29/2021 082B22A 8/29/2022
pt recv vax approx 2PM & by 3PM sl h/a;by 5PM bad h/a, n/v X1, chills & mid abd pain;given APAP;vomited 8PM, sleep on & off all noc;t97.7;next day same temp;
Information has been received from a physician concerning a 7 year old female who on 03-FEB-2000 was vaccinated with a dose of Varivax. On 06-JUN-2006 the patient developed a full blown case of chickenpox. Lesion count was not available. Unspecified medical attention was sought. The was no laboratory or diagnostic tests. At the time of the report, the patient's chickenpox. Additional information has been requested.
pt recv vax 26MAY95 & 7FEB96 lab eval was negative for varicella antibody;
This spontaneous report received from a patient concerned a male of unspecified age, race, and unspecified ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On OCT-2021, the patient experienced suspected covid-19 infection (fever, a change in smells, mainly propane, methane, ammonia, and onions all smell like rotten fish and some smells which cannot be described). On an unspecified date, the patient experienced suspected clinical vaccination failure. The action taken with covid-19 vaccine was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority. This case, from the same reporter is linked to 20220116664.; Sender's Comments: V0; 20220116907-COVID-19 VACCINE suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Syncope episode post vaccination; Required two ammonia ampules to arouse; No apparent injury; Did remain unconscious for 45 seconds
Information has been received from a physician concerning a 6 year old white female who on 12/11/98 was vaccinated in the right arm with a first dose of varicella virus vaccine live. On 2/3/04, in the PM, the patient developed vesicles on the trunk, legs, and arms. It was noted that the patient was afebrile. There was no laboratory diagnostic tests performed. Follow up information indicated that on 2/3/04 in the PM the patient developed vesicles on her trunk, legs, and arms. The vesicles began to disappear on the fourth day. The outcome was reported was recovered on 2/8/04. No further information is expected.
ACHES; CHILLS; NAUSEA; This spontaneous report received from a parent concerned a 27 year old female. 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 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-APR-2021, the subject experienced aches. On 23-APR-2021, the subject experienced chills. On 23-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, aches, and nausea. This report was non-serious.
Local reaction (dime size, red, tender and warm to the touch). Systemic complaints of general malaise, nausea and aches especially extreme chills (afebrile).
Rash started 10/8/13 cont to spread over entire body - feels tired and weak today 10/14/13 - Rash red with itching. Received varicella vaccine 9/30/13 flu vaccine 10/9/13.
At office visit on 11/20/2009 patient received a Varivax injection into left arm she also received the H1N1 nasal flumist.  Approximately 24 hours later the patient complained to her mom about her left arm at the injection site being warm and tender to touch.  She developed a rash which was relatively sparce large erythematous papules, no vesicles noted over her arms, back and abdomen.  The urgent care doctor spoke with the ID fellow who stated that no special prophylaxis was recommended at present. patient is following-up with pcp on 11/24/2009.
INCREASED SLEEP; TIREDNESS; This spontaneous report received from a consumer concerned a 57 year old female. 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced increased sleep. On MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiredness, and increased sleep. This report was non-serious.
SUSPECTED COVID-19 INFECTION; STROKE; This spontaneous report received from a patient concerned a 72 year old  female. The patient's weight was 180 pounds, and height was 66 inches. The patient's past medical history included: In 2020 left knee replacement, (2019) back surgery, (2016) sprained foot, (2011) colonoscopy, (2011) fractured right foot, (2014) neck surgery (had two plates put in neck), and (2012) trigger fingers (patient had two trigger fingers, it locked down when you move it), and concurrent conditions included: sinus, non-smoker and alcohol user, and other pre-existing medical conditions included: Patient did not have drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: unknown) dose was not reported, 1 total, administered on 29-APR-2021 left arm for covid-19 prophylaxis. Age at time of vaccination 72 years old. No concomitant medications were reported.  On MAY-2021, the patient had a stroke within 2 weeks after vaccination. On JAN-2022, the patient experienced suspected COVID-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke and suspected COVID-19 infection was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20230320475.; Sender's Comments: V0: 20230320386-stroke . The event 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. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.
Missed period following month so far; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Oct2021 (Lot number: 3203080) at the age of 44 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes; "PCOS" (unspecified if ongoing), notes: PCOS; "SVT" (unspecified if ongoing), notes: SVT; "Migraines" (unspecified if ongoing), notes: Migraines. Concomitant medication(s) included: TOPAMAX; METFORMIN. Vaccination history included: Bnt162b2 (Dose 1, Single, Batch/Lot No: ff2589, Location of injection: Arm Right), administration date: 05Oct2021, when the patient was 44 years old, for COVID-19 Immunization. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 02Dec2021, outcome "not recovered", described as "Missed period following month so far". The event "missed period following month so far" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of menstruation irregular.  Additional information: There are no other vaccine in four weeks and other medications in two weeks: Topomax, metformin. Patient had covid prior vaccination and the patient did not tested for covid post vaccination.patient had no known allergies  Follow-up attempts are completed. No further information is expected.
Lost the 30% of the smell; Loss the 30% of the taste; Fever; Chills; Sweats; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 22Mar2021 at 15:45 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) 20 mg from an unknown date for unknown indication. The patient previously received Morphine on unknown date for an unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Mar2021 at 21:00, approximately six hours after receiving the first vaccine, the patient experienced fever of 102, chills, sweats and nausea. On 23Mar2021, the patient had lost the 30% of the smell and taste that had regained over the last 6 months since having the COVID in Oct/Nov, all the smell and taste had gone again. Now two weeks later and still could not smell or taste. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the reported events. On 03Apr2021, the patient underwent nasal swab test for SARS-CoV-2 (PCR) and the result was pending. The clinical outcomes of the events fever, chills, sweats, nausea, lost the 30% of the smell and taste were not recovered at the time of reporting.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I had my first Pfizer COVID-19 vaccination on June 17, 2021. Shortly after receiving the first vaccine, I began to experience excruciating headaches. The headaches lasted for approximately three days and then subsided. After receiving the second Pfizer COVID-19 vaccination on July 9, 2021, I began to experience intermittent headaches. On some occasions upon waking up from sleep, my entire face would hurt me. On 7/29/2021, I woke up with an intense headache and facial discomfort. I called and requested to have an appointment with my medical doctor. My doctor gave me two vaccinations, one of which was a steroid shot. I was also prescribed two different medication?s to address my symptoms..