chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a physician via a company representative referring to unspecified number of adolescents of unknown age and gender. The patients' concomitant medications included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (unspecified TDAP) and meningococcal vaccine (unspecified). Pertinent medical history and drug reactions/allergies were unknown. On an unknown date, the patients were vaccinated with their third dose of GARDASIL 9 (dose 3; 0.5 milliliter dose and 0, 2 and 6 months; route, batch/lot# and expiration date were unknown) for prevent of human papilloma virus (HPV). On an unknown date, while in the physician's office, the patients experienced seizure. It was unknown whether treatment was given for the event or not (also reported that the patient was treated in office). It was unknown whether lab diagnostics/studies were performed or not. The outcome of the event was unknown. The event didn't resulted in death or hospitalization. The causality between the event and GARDASIL 9 was unknown. No product quality complaint (PQC) presented. Upon internal review, seizure was considered to be medically significant.
Patient was immunocompromised and received first booster dose after second dose/ No third dose; No adverse event; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient was immunocompromised and received first booster dose after second dose/ No third dose) and NO ADVERSE EVENT (No adverse event) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient does not had any complex allergies.  Concurrent medical conditions included Immunocompromised (Legally disabled but these illnesses are not life threatening).   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient was immunocompromised and received first booster dose after second dose/ No third dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient was immunocompromised and received first booster dose after second dose/ No third dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported.  It was reported that the patient did not had any flu shot last year. Caller stated that his wife was immunocompromised and when asked as to what the immunocompromised he stated that with due respect they did not want to violate HIPAA and would just put it as "legally disabled but these illnesses are not life threatening".  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-653965 (E2B Linked Report). This case was linked to MOD-2022-654320, MOD-2022-654236 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2022: Live Follow up received contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-653965:husband case
next day was very tired with a slight headache; next day was very tired with a slight headache; 12 hours after the injection I got the chills while I was in bed trying to sleep; I did not sleep well that night; 4 hours after the injection my arm was very sore; This is a spontaneous report from a contactable consumer. A 59-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 30Dec2020 09:00 at single dose at left arm for COVID-19 immunization.  Medical history included none.  There were no concomitant medications. The patient reported 4 hours after the injection/reported as 30Dec2020 14:00, my arm was very sore. On 30Dec2020 21:00, 12 hours after the injection, "I got the chills while I was in bed trying to sleep. I did not sleep well that night. The next day (31Dec2020) was very tired with a slight headache. The patient only rested all day. The next day he felt better but was slightly fatigued all day. The day after that the patient was back to being himself. His arm continued to be sore for a total of 5 days. The patient did not receive treatment for the events. The outcome of the events was recovered.   Information on the Batch/Lot number has been requested.
Pt recv vax on 2/23/99; on 2/24/99 pt exp abdominal pain/ sore, bladder hurt, aching joints & muscles x 2 days, painful urination, constipation
Sick for several days; thought I was dying, worried about residual side effects; it hurt to move head, fingers, painful side effects; bones felt like throbbing; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient did not receive Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness, impending doom, pain upon movement and bone pain. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the impending doom, pain upon movement and bone pain were unknown.   The reporter considered the sickness, impending doom, pain upon movement and bone pain to be possibly related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient took the Shingles vaccine and had the worst reaction. The patient experienced painful side effects post vaccine The patient was sick for several days thought she was dying. The patient reported that bones felt like they were throbbing, and it hurt to move head and fingers. The patient was worried about a residual effect down the road. The patient stated do not take this shot. The reporter thought that the event might had been related to the vaccine. The reported did not agreed to contact healthcare professional. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Patient experienced two episodes of syncope after receiving vaccines on 4/21/09. First episode immediately after receiving vaccines, then 15 minutes later, when he got ready to leave. Mother called on 4/23/09 to tell us he started feeling tired and "just not right" the evening of 4/22/09. He did attend school the next day, but came home early due to vomiting. Left arm was swollen at sites of Tdap and also more swollen at site of Varicella vaccine. The area was also very warm to touch. I told mother to call physician. Physician did not think he needed to see the patient. Talked with mother on 4/24/09. He did stay home from school today, but is feeling better.
8 days after vaccine, the vaccine site began with a itchy rash on 01/21/21,  it has since become hot, red circle about 2 inch in diameter, swollen.
Fever, 20 cm x 10 cm very edematous erythemic tender, warm area on lower (R) deltoid muscle posterior more than anterior.
Large hard "lump" at injection site - size of "baseball" - appeared 2 days after injection.  Itched, very sore.  After 2 days - lump is subsiding.
Nose bleed; nose was bloody after itching it; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: ER8733; Expiration Date: Jul2021), via an unspecified route of administration, in Left Arm, on 28Mar2021 at 14:15 (at the age of 33-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. Medical history included diabetes mellitus from 1989 and ongoing. Concomitant medication included insulin lispro (HUMALOG) taken for diabetes mellitus from 2005 and ongoing. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine.  On 29Mar2021 at 11:30, The patient experienced nosebleed, nose was bloody after itching it. It was not dripping blood, but it was inside her nostril. The nosebleed was not treated.   The outcome of the events was recovered in 29Mar2021.  No follow-up attempts are possible. No further information is expected.
Narrative: PATIENT REPORTS A 4 INCH, RED, WARM AREA AROUND INJECTION 5 DAYS POST INJECTION. COMMUNITY PHARMACIST GAVE ALLERGY PILL TO TAKE, SPECIFIC MEDICAITON UNKNOWN.
Redness, swelling app 3" below injection site. Very hot, also pain starting approx 6 hr after.
Comments: LEFT Deltoid, s/p anthrax injection, 10 cm by 10 cm warm, erythematous rash, with well demarcated borders, no active discharge, with TTP noted in a triangle pattern beginning at injection site with Tenderness approx 3 cm both medial and lateral of injection extending distally 4 cm with tapered tenderness. No systemic symptoms.
Face and neck became hot and flushed--then face and neck broke out in a rash. The next day a rash appeared in the middle of back about waist level. There was about a 4 inch long rash on right rib cage. Cortisone cream and Benadryl tablets were taken to help with the itching. By 11/24/2013 symptoms were much improved. However, still have rash on back.
indication=Treatment of COVID-19; indication=Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 18Dec2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetic" (unspecified if ongoing), notes: Other medical History: Type 2 diabetic. There were no concomitant medications. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine. There were no Known allergies reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01May2022, outcome "not recovered" and all described as "indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive; (May2022) Positive, notes: Still testing positive and have harsh cough. 2.5 weeks after testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti viral details: product: COVID 19 Treatment, brand=Paxlovid, Treatment start date=03May2022, Treatment stop date=08May2022, Indication=Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
After 1 hr and 15 min of vaccine administration patient developed hypotension and chest pain. Bolus of normal saline administered as well as Oxygen. 911 contacted, Patient sent to ER for further evaluation.
This spontaneous report as received from a pharmacist refers to 71 year old female patient with not know drug allergies and unspecified medical history. The reporting pharmacist stated that 2 patients reported injection site reactions to PNEUMOVAX 23. On 28-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # K005957, expiration date: 08-MAR-2014; dose: 0.5 ml, intramuscular, anatomical location not reported). Concomitant medications were not reported. The reporting pharmacist stated that, in approximately October 2014 (exact dates not reported), the patient reported a swollen arm, large area of redness "like sunburn", no fever, painful and stinging which has subsided. Pharmacist stated also that the patient received "stents in her heart" at an unspecified time recently (in approximately 2014, exact dates not reported) and was concerned. There was no treatment given for the reported events thus far and the pharmacist suggested ice to the patient which did not help. The outcome of stent in heart, injection site reaction, swollen arm, painful arm and large area of redness like sunburn was unknown. The outcome of stinging was reported as recovered/resolved/subsided (approximately in October 2014, exact dates not reported). The relatedness between the events and the therapy with PNEUMOVAX 23 was not reported. Upon internal review the event of "stent in her heart" was determined to be medically significant. This is one of several reports received from the same reporter. Additional information has been requested.
The next day after shot I developed an induration of site and it became very itchy for 24 hours. Red welt stayed in place about half dollar size for 2 days then went away. Then a week later same symptoms developed. And left a bruise from welt and itching. Lasted 2 days
FULL BLOWN TYPE 2 DIABETES THAT SEEMS NOT TO BE TREATABLE BY ANY MEDICATION; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: full blown type 2 diabetes. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, with frequency 1 total administered on 03-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On AUG-2021, the patient reported that he had full blown type 2 diabetes that seems to not be treatable by any medications and upon researching, the vaccine was responsible for an increase of victims to an extent of 42 percentage. Also stated that three months and he had no signs of this going into remission, diet, exercise and medications did not work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from full blown type 2 diabetes that seems not to be treatable by any medication. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211122616-COVID-19 VACCINE AD26.COV2.S-Full blown type 2 diabetes that seems not to be treatable by any medication. This event is considered unassessable. 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.
Patient tested positive for COVID 07/27/2021, greater than 14 days following last COVID vaccination. Positive COVID finding incidental with pre-procedural testing. Patient is asymptomatic.
Fever; Muscle aches; Headache; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non pregnant female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on an unknown date (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included Known allergies to chocolate. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 16Mar2021 at 08:00, the patient experienced fever, muscle aches and headache. The patient did not receive treatment for the reported events. The clinical outcome of the events fever, muscle aches and headache was recovered on an unknown date in Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient was 29 years old when event occurred, medical history added and narrative updated accordingly.
IATROGENIC PULMONARY EMBOLISM W INFARCTION 8/25/2022 PRESSURE ULCER OF SACRUM STAGE 4 (MUSCLE, TENDON, OR BONE) RESPIRATORY FAILURE, UNSPECIFIED ACUITY 5/7/2022 PRESSURE ULCER OF SACRUM STAGE 4 (MUSCLE, TENDON, OR BONE) IATROGENIC PULMONARY EMBOLISM W INFARCTION 8/25/2022 CHF EXACERBATION, UNSPECIFIED RESPIRATORY FAILURE, UNSPECIFIED ACUITY 5/7/2022 CHF EXACERBATION, UNSPECIFIED IATROGENIC PULMONARY EMBOLISM W INFARCTION 8/25/2022 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION RESPIRATORY FAILURE, UNSPECIFIED ACUITY 5/7/2022 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION
EHS unaware of adverse reaction until 9/22/15 when patient requested flu vaccine exemption. History: Rec'd flu vaccine 10/17/14. Awakened 11/3/14 with (L) arm tingling; 11/4/14 (R) arm tingling also; 11/5/14 feet and legs tingling, progressive to weakness at extremities on 11/7/14. Seen in ES 11/7/14 and hospitalized 1 day. Multiple studies then and since to confirm Dx.
ulcerative colitis; Information has been received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's medical history and concomitant therapy were not reported. On or about 24-MAY-2016, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route of adminstration, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions in a private physician's office. Subsequently, the patient was treated for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: ulcerative colitis. The outcome of ulcerative colitis was unknown. The event of ulcerative colitis was considered to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of ulcerative colitis was determined to be medically significant.
Husband had cough, rhinitis and chest congestion on 12/24 and 12/25/2022.  I tested him on December 24th and his Covid test was positive. This was in the late evening of December 24 so I waited till December 25th and tested him again and he again tested positive. I send a message to his PCP and heard from them on December 26. During this time I tested myself twice between December 25 and December 26. Both times I tested negative. On December 27, I started having chills, body aches, Headache, and extreme fatigue. I tested myself on December 27 and my negative test turned positive. I sent a message to my PCP and when they messaged back they said I qualified for the. PAXLOVID antiviral medication.   I received this medication from the pharmacy on December 28 and that is the  day that I took the first dose.
Rash - erythematous small bumps on trunk and extremities - 12 days after MMRV, Hib, Hep A.
Rash and extremely Itchy skin around injection   Occurred with second dose.  Also occurred with first dose for about a week
2 hours after receiving the vaccine, patient complained of right shoulder pain and immobility, and tingling in right arm
The patient was tired and could only drag herself out of bed to use the bathroom; Headache; Diarrhea; Low grade fever; Joint and muscle pain; Joint and muscle pain; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO217) via an unspecified route of administration in the arm left on 11Jul2021 at 14:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included type II diabetes mellitus (DMII), chronic kidney disease stage 3, syndrome restless legs (RLS), complex post-traumatic stress disorder (CPTSD) and hypertension; all from unknown date and unknown if ongoing at the time of this report and known allergies to penicillin. The patient previously took bee venom (MANUFACTURER UNKNOWN), amphetamine (MANUFACTURER UNKNOWN) for diet pills and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medications within two weeks prior to vaccination. On 12Jul2021 at 05:00, the patient was so tired and could only drag herself out of bed to use the bathroom, headache, diarrhea, low grade fever, joint and muscle pain, joint and muscle pain and nausea. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events the patient was so tired and could only drag herself out of bed to use the bathroom, headache, diarrhea, low grade fever, joint and muscle pain, joint and muscle pain and nausea was recovered on an unknown date in Jul2021.  No follow-up attempts are needed. No further information is expected.
This spontaneous case reported by a consumer, describes the occurrence of fatigue (felt very fatigued) and chills in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced fatigue (felt very fatigued) and chills. At the time of the report, fatigue (felt very fatigued) and chills: resolving. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No relevant concomitant medications or treatment information reported. Reporter did not allow further contact.
8 hrs after vaccine (5:30 pm): chills, headache. 2 extra strength tylenol at 5:30 pm and 11:30 pm. Still headache and chills. 18 hrs after vaccine (3 am): could not move right arm (very little use in arm from ms) and could not walk. Legs would move only slightly without assistance. Arm and legs were better and functioning by 5 pm (14 hrs  later),  Continued to take extra strength tylenol because of temp through Wednesday, April 7
A fib; sore arm; Headache; A Spontaneous  report was received from a consumer concerning a 70 Years old male patient,  who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Atrial Fibrillation, Headache, Vaccination site pain.  The patient's medical history was not provided. No relevant concomitant medications were reported. No information on allergies were provided. The reported stated that the patient was physically and mentally healthy before vaccination   On 29 Jan   2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011M20A)  via unknown route into her left arm for prophylaxis of COVID-19 infection .   On 30 Jan 2021  Patient experienced events such as Atrial Fibrillation, Headache, Vaccination site pain .Investigations include his heart rate which was rapid. Cardioversion procedure was followed to restore the heart rhythm.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the event Atrial Fibrillation was recovered on same date with the treatment procedure. The outcome of events Headache, Vaccination site pain were considered unknown.; Reporter's Comments: This case concerns a 70 Y/O M with a serious unexpected event of atrial fibrillation, and nonserious expected vaccination site pain and headache. Event onset on Day 2 after first dose mRNA-1273. Treatment included cardioversion.  Atrial fibrillation resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
pt recv vax 22JUL96 & 17APR97 pt exp chickenpox w/20 lesions;