chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist concerning a 57 year old female with no pertinent medical history, drug reactions or allergies who on 14-SEP-2007, in the PM, was vaccinated subcutaneously with a first dose into the left arm with Zostavax (Oka/Merck) (Lot 3 658211/0884U). On 15 SEP 2007, at approximately 10:00, the patient developed a localized reaction at the site of injection, left arm, which was warm and painful, with redness, swelling, and itchy. The red area was approximately 2.5 inches in diameter. The swelling was approximately a 1/2 inch from normal. The reported events persisted for 6 days. (Initially the reported area involved was 1 1/2 inches in diameter with swelling of 4 centimeters). The patient was reported to have recovered on approximately 21 SEP 2007. The patient had no adverse events following prior vaccinations. No relevant diagnostic tests were performed. Additional information is not expected.
Approx. 16 hrs. post injections, he experienced vomiting, fever and redness and swelling at the injection site.
Information has been received from a consumer concerning her 5 year old son who was vaccinated with a dose of varicella virus vaccine live. Subsequently the patient developed a case of shingles. No further information was available.
A report has been received from a Health Professional concerning a patient born on 17-Feb-2007, female subject, who had been receiving FLUMIST, 0.2 millilitres, unknown. FLUMIST started on an unknown date. It was reported that expired FLUMIST Lot FJ2073 was given to patient 5 days after expiration date. The outcome of the event of expired dose is unknown. The report was considered to be non-serious.
DIED SUDDENLY; This spontaneous report received from a consumer via a social media (J and J Corporate Online search) and by a company representative concerned multiple patients of an unspecified age, sex, race and ethnicity. The patients weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patients died suddenly two days after having the shot from unknown cause. It was unknown if an autopsy was performed. It was reported that "l know thousands of people who died suddenly two days after having the "jab" shot". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. On an unspecified date, the patients died suddenly from unknown cause of death. This report was serious (Death).; Sender's Comments: V0- 20221131401-Died Suddenly. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
At 1210 pt  complained of feeling lightheaded, denied  shortness of breath, chest pain nausea or vomiting. Pt was taken to the triage site,  Vitals were obtained at 1213 T:36.9 BP:118/70, pulse 74 , O2:98 RR 20 pain:0. Provided water and laid patient down, pt verbalized feeling better. Denied any medical disorders, has eaten and well hydrated. At 1223 vitals were obtained T:37, P: 76, Bp: 118/74 pulse 76 O2 97 pain 0. Patient felt normal and left the center.
This spontaneous report was received from a male patient of unknown age regarding himself. The patient had no pertinent medical history, concurrent condition and concomitant medication. He had no previous drug reactions/allergies. On an unknown date the patient was vaccinated with GARDASIL (strength, dosing details, anatomical location, lot# and expiration date were unknown). On an unknown date, after vaccination the patient experienced swelling in the groin area. The swelling appeared in the head of the penis and had an odor. The patient sought medical attention by visiting physician's office. No treatment was received from the adverse event. Some unspecified lab diagnostic test were performed on an unknown data. The outcome of the events were unknown. Causality assessment was not provided. No product quality complaint was involved. Additional information is not expected as no reporter contact details were provided.
MY EXISTING TINNITUS GOT WORSE FOR ABOUT 2 WEEKS AFTER THE SHOT
Patient Covid + on 10/29/2021. Received Pfizer vaccine with 1st dose # EW0183 on 05/21/2021 and 2nd dose #EW0180 on 06/11/2021. On inpatient Behavioral Health Unite when tested positive. Admitted to unit on 10/17/2021.  Per IM Note from 10/30/2021:  Active Diagnoses      COVID-19   Hyponatremia   Paranoid type schizophrenia   Schizoaffective disorder     Patient is asymptomatic no intervention for COVID-19  Encourage deep breath and incentive spirometer  Monitor his electrolytes  Monitor his markers  Psychiatrist is taking care of his hallucination  Subjective  Patient continues to have auditory hallucination  Denied any fever or chills denied any myalgia denied any coughing or sputum no chest pain
Some arm soreness and dizziness 12 hours after vaccine. Awoke with chills 18 hours after vaccine. Flu-like symptoms from that time for another 12 hours or so: body aches, tiredness, nausea.
No adverse event; 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    No concomitant medications were reported. The vial was initially thawed on 10-Jun-2023.  Treatment medications were not reported.  This case is for 5th patient out of 30 patients reported by reporter.    This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live follow-up significant information received: Drug start date was updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:Master case (patient 1)
Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu vaccine in September 2021. Past adverse reactions to the above products included No adverse event with Flu vaccine.    On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown.            Patient had 1st dose with no side effects No concomitant medications were provided. No treatment medications were provided. Patient experienced mild symptoms after second dose ,which patient thinks those symptoms are normal.   This case was linked to MOD-2021-381878 (Patient Link).
Patient flinched and pulled away during injection causing a trickle of an unmeasurable amount of vaccine to run down her arm.  Per CDC and Department of Health guidelines she received a second dose in the opposite (right) arm.  Patient tolerated procedure well and was monitored closely post vaccinations.
Lt. upper arm red, hot and indurated 8x6.5 cm on 10-18-07 14.5 x 11 cm on 10-19-07 Rx: Augmentin 1 1/2 tsp BID x 10 d; Tylenol with QOD prn. Redness and pain started decreasing 10-19-07 p.m.
Headache, Myalgia, Arthralgia, Fever,  Fatigue Narrative: Fever 102. Day after injection, felt like they had gotten COVID. Was fine the next day.
tested positive for COVID on 27May; tested positive for COVID on 27May; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), in Jan2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The patient has no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27May2022, outcome "not recovered" and all described as "tested positive for COVID on 27May ". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27May2022) Positive; (06Jun2022) Negative; (09Jun2022) Positive. Therapeutic measures, Paxlovid from 27May2022 until 01Jun2022, were taken as a result of drug ineffective, covid-19. Clinical course: The patient tested positive for COVID on 27May2022 and started Paxlovid that same day. Patient tested negative on 06Jun and then tested positive again on 09Jun.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fever of 102 degrees, very painful injection site. severe tiredness.  Symptoms started the day after my vaccine and lasted 24 hours.
I woke up with severe stomach pain. I couldn't walk and had to be in a wheelchair the rest of the day. I started vomiting and threw up several times. They gave me peptide for the vomiting. This lasted for the entire day. I got discharged and am feeling much better now.
A patient received 1st dose 65 days ago and hasn't received 2nd dose yet; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (A patient received 1st dose 65 days ago and hasn't received 2nd dose yet) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included BP, COPD and Diabetes.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (A patient received 1st dose 65 days ago and hasn't received 2nd dose yet). On 13-Apr-2021, PRODUCT DOSE OMISSION ISSUE (A patient received 1st dose 65 days ago and hasn't received 2nd dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was reported. Patient took 2nd dose on 17-jun-2021, Batch no. 014C21A, Intramuscular, LEFT DELTOID, with no Event reported in FU-1   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Significant FU - Patient demographics provided, batch number provided, Reporter location
Both husband and myself had 2nd Shingrex Vaccine. Had no problem after the 1st. This one after 12 hours we had very severe shivers,shaking,body aches,nausea,stomach upset, low fever, tingling and pain in soles of feet. Took 2 days before we felt like ourselves again
Migraine type headache, constant (better with Aspirin), loss of appetite, vomiting.
lethargic, fatigue, with sore that came up in roof of mouth 4 days after injection.
Pt recvd vax & exp diaphoresis & dizziness; treatment DPH;
Patient hospitalized for normal labor and delivery of healthy baby boy. No information given regarding baby, but it was mentioned the baby was jaundiced.
SUICIDE; INJURED; This spontaneous report received from consumer via other manufacturer (Pfizer) through social media (JNJ News) concerned multiple patients. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, start therapy date were not reported 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patients lost (died) to suicide who were injured by vaccine. It was not reported if an autopsy was performed or not. It was reported that, "After l-year and sometimes less of suffering, I lost friends to suicide who were injured by the moderna tx pfizer JNJNews. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injured was not reported. This report was serious (Death).; Sender's Comments: V0: 20230407711- Suicide. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: SUICIDE
Patient fell 15 minutes after vaccine. BP 168/93 (pulse 90), 97% O2 sat. BP 151/84 (pulse 89), 97% O2 sat.
This case was reported by a other health professional and described the occurrence of unspecified adverse event in a female patient who received BOOSTRIX. In 2010, the patient received BOOSTRIX. In 2010, less than a year after receiving BOOSTRIX, the patient experienced unspecified adverse event. On an unknown date, the outcome of the unspecified adverse event was unknown. It was not reported if the reporter considered the unspecified adverse event to be related to BOOSTRIX.
PATIENT RECEIVED FIRST DOSE OF MODERNA COVID 19 VACCINATION. AFTER VACCINE PATIENT FELT DIZZY AND FELL ONTO THE FLOOR AND PASSED OUT. PATIENT THEN QUICKLY WOKE UP AND WAS CONFUSED AND DISORIENTED. PARAMEDICS WERE CALLED AND PATIENT WAS TRANSPORTED TO HOSPITAL FOR FURTHER EVALUATION.
14DEC97 fever, coryza;taken to PMD 16DEC fever 103 treated for otitis w/ATB;devel macules papular rash 17DEC;eval by PMD to be allergic react to ATB;pt cont fussy;
At about 1am the night following receiving the vaccine, I started getting a headache and indigestion. At about 1:30 I had diarrhea for the next 3 hours until I took an anti-diarrheal medication.  My wife and I ate the same food that day. She did not get sick. I haven't had diarrhea in years.  I had a lingering headache the following day.
This case was reported by a nurse practitioner and described the occurrence of bone pain in an 18 yr old male subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix) plus a separate injection of hep A vaccine inactivated (Havrix). Medical history included acne. Concurrent medication included Isotretinoin (Accutane). On 15Mar06 the subject received 1st dose of Boostrix (lotAC52B005AA). On 15Mar06, the subject also received the 2nd dose of Havrix (lotAHAVB099AA). On 15Mar06, less than one day after vaccination with Boostrix and Havrix, the subject experienced bone pain, hand tingling, headache, nausea and chills, but no fever. The subject was seen at a physician's office. On 23Mar06, the subject experienced a fever of 104 degrees F and diarrhea. On 23Mar06, hematological analyses were notable for an elevated white blood count of 14,000/mcL, an elevated absolute neutrophil count of 11606 cells/mcL, and an elevated absolute monocyte count of 910 cells/mcL. Tests for rheumatoid factor, Lyme disease and antinuclear antibodies were negative and Epstein Barr viral serology indicated no new infection. At the time of follow up antibodies were negative and Epstein Barr viral serology indicated no new infection. At the time of follow up reporting, 25Apr06, the events had improved. The nurse practitioner considered the events to possibly be related to vaccination with Boostrix and Havrix. She also stated that the subject's dermatologist felt Accutane might have caused the bone pain.
The patient received Moderna but is 13 years old. At this time it is not approved for 13-year-old individual. No adverse reaction occurred.
Patient with increased numbness and with progressive numbness in hands. Progressive ataxia and unable to walk without assistance. Patient also reporting an URI.
Went to emergency department due to redness on arm and was told she developed cellulitis. Was prescribed Bactrim DS 7/19, then cephalexin 7/20 followed by an injection of rocephin at the ER on a subsequent visit.
Headache, Myalgia, Fever, Chills Per nursing report: "2nd dose of COVID 19 on 2/8/2021 at 8am and started with symptoms by 4pm on 2/8/21. Employee report at 2am [2/9] she woke with severe headache, chills, low grade fever --- 99.1, body aches in her arm and neck. "
crying non stop for 1 1/2 hrs evening p/vax; t105 ax; rt leg red swollen, did not want to eat;
mom called 23APR96 to report that pt began a screaming cry @ 7PM 22APR96 which cont x 3hr followed by sleeping x 1/2 alternating w/crying x 1hr throughout the noc which cont until 3PM 23APR96
Patient stated that around 10pm on 8/3 he started experiencing severe muscle aches and numbness in both arms. The pain kept him up all night and was still severe this morning. I encouraged ibuprofen/apap to help with the aches.
BODY ACHES; CHILLS; SPLITTING HEADACHE; TEMP 101.5; FEEL LIKE ABSOLUTE CRUD; COULDN'T SLEEP; This spontaneous report received from a patient via a company representative . The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine for prophylactic vaccination. 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 05-NOV-2021, the patient experienced couldn't sleep. On 06-NOV-2021, the patient experienced feel like absolute crud. On an unspecified date, the patient experienced body aches, chills, splitting headache, and temp 101.5. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Temp 101.5. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temp 101.5, splitting headache, chills, body aches, couldn't sleep and feel like absolute crud was not reported. This report was non-serious.
Extremely sore arm for entire day after injection (painful to move and use); severe headache (morning after - present, approximately 48hrs after injection).
Erythema/ induration at DTaP site on leg. RX ancef, Keflex x 5 days warm compresses. 04/18/05- completely resolved, no further problems.
Patient stated she developed chest tightness, shortness of breath, temperature maximum of 100.4, body aches, lightheadedness and headache.
I was experiencing pretty bad diarrhea/it has been consistent since saturday/I've had it for 2 days straight; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (I was experiencing pretty bad diarrhea/it has been consistent since saturday/I've had it for 2 days straight) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A and 025C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021, the patient experienced DIARRHOEA (I was experiencing pretty bad diarrhea/it has been consistent since saturday/I've had it for 2 days straight). At the time of the report, DIARRHOEA (I was experiencing pretty bad diarrhea/it has been consistent since saturday/I've had it for 2 days straight) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medication  reported as OTC allergy pill.  The treatment included was Drinking more water, limiting diet.
Chills, severe headache for about 8 hours, mild headache lasting 36+hours. Left armpit lymph node swelling and soreness
My left side of my body, arm torso and breast, feel swollen. This started early Monday morning around 8 am and has continued.
Long lasting period.  Currently on day 12.  Heavy bleeding and cramping with times of just spotting.  Passing large clot.
Severe headaches on the left side of head causing eye pain , temperature of 100.1, tingling throughout my whole body including fingers and toes, extreme fatigue.  All symptoms started at approximately  2:00am the day after vaccination when I woke up in the middle of the night.
1/21/2021, 48 hours after 1st dose, collapsed at home. Possibly triggered A Fib and went to ER with BP 180/110.  CVA verified by MRI of brain.   Drs suggested that Pradaxa was not strong enough to prevent stroke when A Fib was triggered. Anticoagulant changed to Eliquis.
Influenza like illness; throwing up; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Influenza like illness) and VOMITING (throwing up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Influenza like illness) and VOMITING (throwing up). At the time of the report, INFLUENZA LIKE ILLNESS (Influenza like illness) and VOMITING (throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
She reports pain with elevation of her arm, tenderness and swelling at the injection site lasting for about 6 weeks now.