chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient stated today 11/08/2021 had flu like symptoms starting evening of 11/2/21 of vaccination. Stated had muscle aches, sore, fatigue, chills, headache, loss of smell/taste. Also reported caretaker had similiar
very very sick /really sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very very sick /really sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 and Myocarditis (Myocarditis/Pericarditis).    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (very very sick /really sick). At the time of the report, ILLNESS (very very sick /really sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took steroids (which takes on a daily basis) to treat symptoms.  Treatment information was not provided.   This case was linked to MOD-2021-314597, MOD-2021-314599 (Patient Link).
R deltoid w/ exfoliated area 4x6cm, no tenderness/swelling.  Advised to keep clean & observe.
They got really ill after the first dose; After second dose had minor reactions; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (They got really ill after the first dose) and IMMUNISATION REACTION (After second dose had minor reactions) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (They got really ill after the first dose) and IMMUNISATION REACTION (After second dose had minor reactions). At the time of the report, MALAISE (They got really ill after the first dose) and IMMUNISATION REACTION (After second dose had minor reactions) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   This case related to patient 3 out of 4 patients.  Concomitant medication was not provided.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-743464, MOD-2023-743536 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743464:Master Case MOD-2023-743536:Patient 3
Blisters & hyperpigmented rash 5cm x 5cm area of left upper arm. Treated with PEDIAPRED tapered dose over 7 days.
Presents to the ED with chief complaint of cough, congestion and concern for electrolyte imbalance. Incidental finding of COVID-19+; tx w/abx & zinc. Dc'd home.
Received 0.5ml Fluzone on 10/19/05. 10/20/05, experienced a non MI cardiac event with cardiomyopathy. Discharge summary states myocarditis, diaphoresis, nausea. msv
blood pressure was elevated; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (blood pressure was elevated) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Brain injury (Due to motor vehicle accident) in 2014, Jugular vein thrombosis (Due to motor vehicle accident; treated with warfarin) in 2014 and Motor vehicle accident in 2014. Concomitant products included BUPRENORPHINE HYDROCHLORIDE, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), PREGABALIN (LYRICA), CYCLOBENZAPRINE HYDROCHLORIDE (AMRIX), ZOLPIDEM TARTRATE (AMBIEN) and VORTIOXETINE HYDROBROMIDE (TRINTELLIX) for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced HYPERTENSION (blood pressure was elevated). At the time of the report, HYPERTENSION (blood pressure was elevated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood pressure measurement: elevated (High) elevated. On 08-Jun-2021, Blood pressure measurement: 140/89 mmhg (High) 140/89 mmHg.         No treatment information was provided.
Developed fever 3/26/09/ER visit for febrile seizure / URI.
Child woke from nap w/fever 105.8-106.Sz, CPR to ER via amb.Pediatrician exam pt & felt no permanent effects from exp.
Five hours after injection pt had chills, fever up to 102, injection site with 4x5cm of erythema with warmt and tenderness.
LOTS OF HEAD PRESSURE; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 30 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known drug allergies. The patient had no relevant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-JAN-2022, the patient experienced cough, chest congestion, trouble breathing (suspected covid-19 infection and suspected clinical vaccination failure) and tested positive for covid-19. On 02-JAN-2022, the patient experienced lots of head pressure and tested positive for covid-19 at the doctor. It was a rapid test because patient got the results in 15 minutes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection, lots of head pressure and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). The case was associated with Product quality complaint 90000210218.; Sender's Comments: V0: 20220105438-Covid-19 vaccine ad26.cov2.s-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
I tested positive for COVID 19 on 12/21/2022 I experienced a fever of 101.0 and I started to have nasal congestion and sinus congestion with extremely sore throat I also experienced muscle aches. I was prescribed PAXLOVID for my symptoms. I still have the sinus congestion and nasal congestion.
having some numbness in the limbs/having some numbness in the face/numbness and tingles on my left arm and foot/last night in the middle of the night it started to travel across my chest, upper back to my right arm and hand; all sweat up; having some tingling in the limbs/having some tingling in the face/numbness and tingles on my left arm and foot; felt faint; sore arm; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (having some numbness in the limbs/having some numbness in the face/numbness and tingles on my left arm and foot/last night in the middle of the night it started to travel across my chest, upper back to my right arm and hand), HYPERHIDROSIS (all sweat up), PARAESTHESIA (having some tingling in the limbs/having some tingling in the face/numbness and tingles on my left arm and foot), DIZZINESS (felt faint) and VACCINATION SITE PAIN (sore arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced HYPOAESTHESIA (having some numbness in the limbs/having some numbness in the face/numbness and tingles on my left arm and foot/last night in the middle of the night it started to travel across my chest, upper back to my right arm and hand), HYPERHIDROSIS (all sweat up), PARAESTHESIA (having some tingling in the limbs/having some tingling in the face/numbness and tingles on my left arm and foot), DIZZINESS (felt faint), VACCINATION SITE PAIN (sore arm), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, HYPOAESTHESIA (having some numbness in the limbs/having some numbness in the face/numbness and tingles on my left arm and foot/last night in the middle of the night it started to travel across my chest, upper back to my right arm and hand), HYPERHIDROSIS (all sweat up), PARAESTHESIA (having some tingling in the limbs/having some tingling in the face/numbness and tingles on my left arm and foot), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown and DIZZINESS (felt faint) and VACCINATION SITE PAIN (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. treatment medication includes antihistamines   Most recent FOLLOW-UP information incorporated above includes: On 04-Dec-2021: follow-up received on 04-DEC-2021 contains significant information which includes patient demographic details updated, new events  added, treatment information added
PT REPORTS "FEELING FLUSHED & ITCHY" ABOUT 10 MINUTES AFTER INJECTION, THEN THE FOLLOWING DAY EXPERIENCING HEADACHE, NAUSEA AND FATIGUE WHICH KEPT HER IN BED FOR THE NEXT FEW DAYS. SYMPTOMS RESOLVED AFTER A WEEK OR MORE. SHE DID GO TO AN URGENT CARE FACILITY & REPORTS BEING ASSURED IT WAS A REACTION TO FLU IMMUNIZATION.
Got Hep B vaccine on 2/24/17. That night was fussy. Had pain in leg next night and wouldn't walk. Fever to 103 and hives. Seen in ER. Strep (-). Next day fever, limp and walk resolved.
Painful, hard, red spot around injection site approximately 2? in width. Neck stiffness. Upper body aches
Moderna arm. Lumpy swelling three inches down from injection. Red hive looking ring around my upper arm.  It itches
Wheezing, cough, mild hypoxemia started same day vaccine given following 2 days.
Pt vaccinated with Hepatitis-B 30 min after inject c/o redness & itching above the inject site - radiating to neck - down lt side to waist. c/o being nauseated-faint feeling-flushed face. To ER given Benadryl inject.
Swelling of her right arm.  Doctor started her on Keflex and it resolved.
Left upper arm was very swollen, red rash, appearance of cellulitis, and required medical attention. Pt was given vaccine on day of discharge (7/29). Pt went to facility and 7/30 & 7/31 he saw Dr. and received antibiotics and antihistamines. On 8/3 significant improvement.
temperature of 101.7; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (temperature of 101.7) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced BODY TEMPERATURE INCREASED (temperature of 101.7). At the time of the report, BODY TEMPERATURE INCREASED (temperature of 101.7) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: high (High) 101.7.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Severe flu-like symptoms. Aches, fever (101), chills, fatigue, headache.
This spontaneous report was received from a physician, referring to an 11 year old female patient. The patient's medical history included vaccination with VARIVAX and M-M-R II. Her concurrent conditions and drug reactions/allergies were not reported. On approximately 03-MAY-2018 (reported as 3 weeks ago), the patient was vaccinated with PROQUAD for prophylaxis (dose, frequency, route, lot #, and expiration date were not reported), which was intended to be administered to her sibling. On the same date, the patient also received ADACEL (dose, frequency, route, lot #, expiration date, and indication were not reported) and MENACTRA (dose, frequency, route, lot #, expiration date, and indication were not reported). No adverse effects were reported. The PROQUAD vaccination was then considered as an "extra dose" as she previously completed VARIVAX and M-M-R II series. This is one of two cases received from the same reporter. Sender's Comments: US-009507513-1805USA012316.
Developed allergy to nickel and then 4 months later developed widespread hives throughout back, abdomen and upper body
The patient started seizing, she was pale, pupils dilated. Pt was laid down and tongue depressor was placed to prevent her from biting her tongue. Her boyfriend was present and reported it just started. The seizure lasted for 1 min. Vitals: Blood pressure: 119/77, pulse 51, O2 sat 97%. Pt reported that she gets seizures when she has received injections in the past. She reported that it hadn't happened since she was a child. She is not on any medication for seizures. Pt sat for an additional 15 min, vitals before she left: Blood pressure: 107/67, pulse 75
recovering from COVID; recovering from COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 70-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovering" and all described as "recovering from COVID". Patient was at home and had sniffles, a bit of a cough, and get to take extra naps.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201274674 Same reporter/event, different patient;
Pt devel Hep B following vax w/Hep B vax; No further details were provided;
went to get a booster last year, she received a third dose instead.; felt super tense and hipper after the third dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of TENSION (felt super tense and hipper after the third dose.) and ACCIDENTAL OVERDOSE (went to get a booster last year, she received a third dose instead.) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 9399021, 031L20A and 011C20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy (allergic to codeine) and Latex allergy.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (went to get a booster last year, she received a third dose instead.). In August 2021, the patient experienced TENSION (felt super tense and hipper after the third dose.). At the time of the report, TENSION (felt super tense and hipper after the third dose.) had resolved and ACCIDENTAL OVERDOSE (went to get a booster last year, she received a third dose instead.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No medical history was reported.   No concomitant medications were reported.  Patient was never had COVID positive test or diagnosis. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. The patient was not immunocompromised.  No treatment medications were reported.
Seizure 7:30PM on 7/10/09 and at 8:30am while asleep. 8/5/09 Primary care provider medical records received DOS 6/17/09 to 7/14/09. Includes portion of neurological consultation records previously abstracted and coded. Assessment: Seizures. Parent has informed primary care provider that child has had 3 seizures since vaccine administration.
First Dose Pfizer, Second Dose Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (First Dose Pfizer, Second Dose Moderna) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 09-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (First Dose Pfizer, Second Dose Moderna). On 09-Jun-2021, INTERCHANGE OF VACCINE PRODUCTS (First Dose Pfizer, Second Dose Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was reported.  No treatment medication information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: The follow up received is non significant no new information was updated
10 days post vax had low grade fever, croupy-like rash & spotty macular rash trunk
Dose #1 blistery rash appeared around and on eyelid of left eye and down left side of face and left side of mouth and throat. Dose #2 blistery rash appeared around and on eyelid of right eye and down right side of face, neck and arm.
Treatment of COVID-19; 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 female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Allergy"; Ibuprofen, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was not taking any other medications within 2 weeks of starting COVID-19 treatment. She took Paxlovid treatment from 23Mar2023 to 27Mar2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Received vaccine just before 0830 am on 1/19. At about 8:30 pm 1/19 starting feeling feverish. Arm was sore and couldn?t be raised above shoulder height. Had nausea, body aches, developed migraine and neck ache so severe I couldn?t turn my head left or right. Developed dizziness and malaise. Fever was 100.5  F. Went home from work and took cold/flu medicine. Symptoms lasted about 3 days.
patient reports subdural hematoma 5 weeks following a fall, decreased platelets with increased size and large bruise at the injection site.  Pt was seen at neurology office
Patient stopped making eye contact, stopped saying "momma" and "dada", puffy face, major eczema, water eyes, ear infections, beef allergy, now has: speech delayed and auditory and vestibular disorder. Ear tubes, EPI-PEN, speech and OT therapy, beef allergy diagnosed 3-27-14 "am hours" and pediatrician office gave flu shot on 3-27-14 "pm hours". (Confirmed gelatin in flu vaccine after given. + dr. office informed of beef allergy prior to administering flu shot to patient. Various on going medical conditions after receiving this flu shot.
This spontaneous report as received from a pharmacist along with staff members in the pharmacy via a company representative refers to an unspecified number of patients of unknown age and gender (mentioned as "all of their patients"). Information regarding relevant medical history and concurrent condition were not reported. On unknown date, the patient were vaccinated with ZOSTAVAX (dose, route and lot # not reported). Information regarding concomitant medications was not reported. The reporters commented that all their patients had reactions to ZOSTAVAX and their arms swell (onset dates unspecified). The outcome of the events was unknown. This is one of several reports received from the same source. Additional information has been requested.
Dx Guillain-Barre Syndrome. Tx Hospitalized at hospital from 2/2 to 2/8/2012. Received 5 days of IVIG. Discharged home stable.
Vaccine dose 2 caused severe fever, headache, muscle pain. Fever persisted for ~3-4 days, peaking on day 2.  9 days post vaccine developed sudden allergy and broke out in hives on neck, hands, belt line that spread to head, shoulders, chest, legs, groin, hands and arms.  Throat swelling at day 10 post vaccination, and again on day 12. Now required to carry epi-pen.  Sought medical treatment on day 10, and started on course of steroids and antihistamines. After sever throat swelling on evening of day 11, returned to dr. to receive more antihistamine prescriptions and epi-pen prescription.
I experienced vaginal bleeding. I had had a hysterectomy many years ago, so this was abnormal. I contacted my doctor who had me to come in and explained the things I should watch for. I never experienced any of the symptoms he mentioned. However, I do still have vaginal bleeding with pelvic pain which I treat with a heating pad and over the counter medications. I was referred to an obstetrician/gynecologist for treatment. No medical test was performed but I do have upcoming appointments. I thought that this was due to the Endometriosis, but I am not sure.
Ringing or Buzzing in both ears. Noticeable a few day after 2nd shot. No treatment. Continuous since injection. On a scale of 1 - 10, I would rate it at 4.
DATE OF MANUFACTURE: 10/2021 WITH EXPECTED EXPIRATION OF 9/30/22. VACCINE ADMINISTERED ON 10/3/22