chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX (lot # and route not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2016, a healthcare provider administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 01-OCT-2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX vaccine, and suffered physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
This spontaneous report was received from a physician via company representatives and from a support services director concerning to a  patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications was not reported. On 07-JAN-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5ml SD-PFS LLok w Tip" which had the lot # K009874 with expiration date 19-MAR-2016 (dosage number and route of administration were not reported). On an unspecified date, the vaccine had a temperature excursion for 136 hours in which the highest recorded temperature was 59 degrees Fahrenheit (15 degrees Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported and no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 19:15 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) 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: "Depression" (unspecified if ongoing); "PCN allergy" (unspecified if ongoing). The patient took concomitant medications. Patient had received other medications in two weeks: Dietary supplements of various brand from 01Jan2022 to 13Oct2022. Patient received Paxlovid from 13Oct2022 to 18Oct2022 for Covid-19 treatment. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Outcome of the events was unknown.   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.
pt recv vax 30OCT97 & became pregnant;pregnancy was confirmed by a urine test;LMP was 7NOV97;expected date of delivery is 14AUG98;pt had a miscarriage @ 8wk of pregnant;
HAVING TREMORS; This spontaneous report received from a consumer via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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 an unspecified date, the patients experienced having tremors. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of having tremors was not reported. This report was non-serious.
No adverse event. This was a medication administration error - the patient has had 2 prior doses of Moderna and came in for  a bivalent vaccine but the MA administered the monovalent Pfizer.
LA was hurting. Started 2 days after injection. Patient called doctor about pain. Doctor said possibly from administration. Patient came in to pharmacy today to pick up pain meds. Looked at arm 1/8 inch bruise at injection site. About 2 1/2 inch circumference bruise on upper posterior arm, when patient questioned, claimed been there for many months, by hitting a shelf. (Questionable: outer bruise, brown, yellowish, white center did not look new). Unrelated hospital visit because of knee abrasion looked infected. Switch Levaquin to Augmentin.
immed post vax Temp inc 2 degrees;severe pain rt arm @ inj - shoulder, neck, throat, ears, nausea, chills;could not move rt arm @ all; x 24hr & now cont w/extreme soreness;
Rec'd FLUMIST 12-17-15 about 330PM -12-18-15 at 9:30PM. Nostrils and left cheek swollen - got worse. Went to ER and was admitted for allergic reaction -possible to FLUMIST - given BENADRYL and ZANTAC. Discharged the next day. We will refer to allergist.
12JAN99 pt recv vax & 2 days later lt leg red & swollen on medial side of legs;warm to touch
Redness at injection site, like along where bandage was; Little sore, it hurts a little at the touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at injection site, like along where bandage was) and VACCINATION SITE PAIN (Little sore, it hurts a little at the touch) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site, like along where bandage was) and VACCINATION SITE PAIN (Little sore, it hurts a little at the touch). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection site, like along where bandage was) and VACCINATION SITE PAIN (Little sore, it hurts a little at the touch) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details were provided. No treatment medication details were provided.   This case was linked to MOD-2021-059899, MOD-2021-059899 (Patient Link).
Information has been received from a registered nurse concerning a 9 year old female who was vaccinated with VARIVAX (Oka/Merck) intradermally. The patient developed redness and swelling at the injection site on her right forearm. The patient's redness and swelling at the injection site persisted. The patient sought medical attention and visited to school nurse. This is one of several reports from the same source. Additional information has been requested.
Swelling all over - rash all over her body.  Dizzy headed, body aches in joints - tired a lot - headaches - period not regular, can run 2 weeks or longer - asthma. 8/25/08-records received-office notes. 3/7/07-C/O shortness of breath, fever, chills times 2 days with cough today. Assessment URI, herpes simplex, asthma.  C/O fatigue, weight loss. received HPV4 and meningococcal vaccines. Assessment: hypothyroidism. 8/27/07-see in office for follow-up after ED visit for spider bite on left thigh. Assessment: abscess and cellulitis. Followed by visit 8/29/07-for incision and drainage of abscess. 9/5/07 second HPV 4 vaccine given. On 12/10/07-C/O rash for 2 months, itching all over body. 12/14/07-rash continues, asthma acting up, nausea. 12/21/07 rash all over, eyes swollen. Treated with steroids. Allergic reaction. 1/30/08 lips swollen times 2 days. 3/26/08-menstral cycle every 2 weeks. 8/6/08-rash continues but not as severe, occurs on waking and diminishes through the day.
rt arm red/warm area around inject site; neg lymphangitis; neg fever; neg nausea/vomit x 3 days;
Fatigue and leg soreness that started a few minutes after receiving vaccines and continued 18 hours post vaccine.  Advised Tylenol to parent
the patient received and expired dose of MMR II; This spontaneous report was received from a medical assistance, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 10-FEB-2020, the patient received an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant Human albumin (rHA) (M-M-R II) lot # R001658, expiration date 17-JAN-2020, for prophylaxis (strength, dose, route and frequency were not reported) reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) lot #R034107, expiration date 24-JUN-2021.
Patient came to immunization clinic for first dose of vaccine.  Directly after receiving vaccination patient became dizzy, pale, and diaphoretic. Rapid Response called.  Vitals obtained.  Patient hypotensive and bradycardic.  Patient moved to gurney, placed in trendelenburg position.  Vitals obtained.  Patient moved to observation treatment area.  Orthostatic vitals obtained as patient recovered.  Patient observed for extended period of time after recovering.  Patient went home with instructions to seek medical care if symptoms worsen.
Pt experienced redness and swelling left deltoid upper arm. Pt was diagnosed with cellulitis left shoulder. Pt was treated with Rocephin.
Full dose 0.5ml were given, instead of 0.25ml to the patient. Clinic monitored patient, no adverse side effects reported or observed. Patient is fit for full-duty.
Chills; Itchy rash;  Big red rash; Swollen arm; This spontaneous case was reported by a physician and describes the occurrence of RASH ERYTHEMATOUS (Big red rash), RASH PRURITIC (Itchy rash), PERIPHERAL SWELLING (swollen arm) and CHILLS (Chills) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.  Concurrent medical conditions included Allergic reaction to drug (allergy to omnicef.), Allergic reaction to drug (allergy to adhesive.), Allergic reaction to drug (Allergic to chlorhexidine) and Environmental allergy. Concomitant products included SPIRONOLACTONE for Acne, ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, COENZYME Q10 [UBIDECARENONE] for Product used for adjunct to statin, MONTELUKAST SODIUM (SINGULAIR) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Seasonal allergy, COLECALCIFEROL (VIT D [COLECALCIFEROL]) for Vitamin D deficiency.    On 26-Jan-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Big red rash), RASH PRURITIC (Itchy rash) and CHILLS (Chills). On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; PREDNISONE at a dose of 1 dosage form every other day and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (Big red rash), RASH PRURITIC (Itchy rash) and PERIPHERAL SWELLING (swollen arm) had resolved and CHILLS (Chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-230100 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Patient demography, medical history, lab data, concomitant drugs
Dull ache in left side of chest near breastbone.Unable to sleep. Began 9:30pm. Emergency room visit 2pm next day.
It?s either a weird reaction to the COVID-19 Vaccine or a coincidence. I may have had a reaction to the Pfizer COVID-19 vaccination.  To support my breast reconstruction implants after a double mastectomy in 2013, I have ?internal slings? built with SurgiMend.  I first attributed soreness under my breasts to my new puppy pulling as she learned to walk on a leash in late February.  Last week the area was so painful I thought I had torn the support slings and would need to call my oncologist for a referral.  I have now realized the soreness days coordinated with my two vaccination  dates. I have heard about people with dermal fillers having a reaction and wonder if my under breast soreness was a similar type of reaction.  The soreness was gone after a couple of days.  Is anyone else reporting something similar? 1st Vaccination February 23, 2021 Hospital,  Pfizer-BioNTech  Lot EN5318  Exp: 05/21 2nd Vaccination March 17, 2021  Hospital, Pfizer-BioNTech  Lot EN6205 Exp: 06/21
4/13/21 - 7:00p.m. - slightly dizzy, small headache 4/14/21 - 2:00a.m. - 10:00p.m. - very dizzy, migraine headache  4/14/21 - 1:00p.m - 4:00p.m. - vomiting, fatigue 4/14/21 - 4/16/21 - fatigue ***** 4/21/21 - 5:00a.m. - injection site very red, swollen, painful; pain radiating down to fingers, up right jaw and under arm to lymph nodes 4/222/21 - redness at injection site subsided by about 65%; very painful lymph nodes through 4/24/21 4/27/21 - redness barely visible; mild/moderate lymph node pain continuing and slowly subsiding
Patient did her schedule for the 2nd dose of Moderna vaccine on 5/21/21 using Vaccine Clinic . However, the patient visited our Pfizer vaccine clinic on 5/14/21, 1 week earlier than her appointment.  For that reason, the patient was accidentally administered the Pfizer vaccine as the 2nd dose at our  Vaccination clinic.  She received the first dose of Moderna vaccine at another vaccination location on 4/17/21. Patient was notified for the incident and properly monitored for side effects after the Pfizer dose.   She did not experienced any side effect then (continued)
really bad reaction - dose 2; could not walk - dose 2, could not go upstairs - dose; fever of 103°F - dose 2; chills - dose 2; fatigue for two days - dose 2; muscle pain - dose 2; headache - dose 2; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (really bad reaction - dose 2), GAIT DISTURBANCE (could not walk - dose 2, could not go upstairs - dose), PYREXIA (fever of 103°F - dose 2), CHILLS (chills - dose 2) and FATIGUE (fatigue for two days - dose 2) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, 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 experienced VACCINATION COMPLICATION (really bad reaction - dose 2), GAIT DISTURBANCE (could not walk - dose 2, could not go upstairs - dose), PYREXIA (fever of 103°F - dose 2), CHILLS (chills - dose 2), FATIGUE (fatigue for two days - dose 2), MYALGIA (muscle pain - dose 2) and HEADACHE (headache - dose 2). At the time of the report, VACCINATION COMPLICATION (really bad reaction - dose 2), GAIT DISTURBANCE (could not walk - dose 2, could not go upstairs - dose), PYREXIA (fever of 103°F - dose 2), CHILLS (chills - dose 2) and MYALGIA (muscle pain - dose 2) outcome was unknown and FATIGUE (fatigue for two days - dose 2) and HEADACHE (headache - dose 2) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) The result was 103 fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was taking concomitant medication that did not want to disclose. No treatment medications were provided.   This case was linked to MOD-2021-433504, MOD-2021-433560 (Patient Link).
Side effects included arm soreness in the entire upper arm, pain in my back around the lower lung area when I would clear my throat, fever, odd sensation in my entire left arm and cheeks, and some body swelling. The pain in my back when clearing the throat shifted towards my spine, then started to radiate outward.  All symptoms gone except for soreness in the arm and the feeling in my cheeks. It feels like when you?ve been numbed by the dentist, and that numb tingly fades, but your mouth doesn?t feel awake.
17DEC sick feeling-like had the flu, feels the same 2 days later; feel tired, chilly (cold);
Dose: 5 (Pfizer)/ Dose: 4, 3, 2 and 1 (Moderna); COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 67 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Feb2021 as dose 1, single (Lot number: 016M20A), in left arm, on 15Mar2021 as dose 2, single (Lot number: 032M20A), in left arm, on 06Nov2021 as dose 3 (booster), single (Lot number: 058F21A), in left arm and on 04Apr2022 as dose 4 (booster), single (Lot number: 048221A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure (controlled with meditation); "High cholesterol" (unspecified if ongoing), notes: High cholesterol (controlled with medication). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" (Dec2022) and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Sep2022, outcome "unknown", described as "Dose: 5 (Pfizer)/ Dose: 4, 3, 2 and 1 (Moderna)". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 04Dec2022 to 09Dec2022.
Pt developed hives generalized all over body, but no anaphylaxis, no allergy, no difficulty breathing. Pt still active, alert, responsive.
Patient felt dizzy. info from MD office-15 minutes after receiving vaccine, patient felt dizzy-given 15 mg Benadryl-no other symptoms. Recovered and was sent home
2/5 Shot was given in left upper arm 2/6  8am - moderate pain in left upper arm, light body aches and hot flashes started          Later in the day - severe pain in left upper arm & unable to raise arm @ the shoulder, continued          light  body aches, and hot flashes continued, fatigue 2/7  Still unable to use/raise left arm, light body aches, fatigue but hot flashes stopped. 2/8  Motion & function of left arm is good.  Still sore where shot was actually given, but able to move &          use the arm.  Up for approx an hour, took a shower & out of the shower the left side of my cervical neck locked up and was unable to flex left ear to left shoulder.  This lasted until 2/18 before full ROM returned.
Blood pressure under 40/60; cyst in the brain; lost his vision,; dizzy; turned white; couldn't speak; felt something on his back (like a pull on his back); eyes went back; arm hurts towards his chest; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOTENSION (Blood pressure under 40/60), CEREBRAL CYST (cyst in the brain) and BLINDNESS (lost his vision,) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C221A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.). Concomitant products included MULTIVITAMIN & MINERAL and ASCORBIC ACID (VITAMIN C ACID) for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced HYPOTENSION (Blood pressure under 40/60) (seriousness criterion hospitalization), CEREBRAL CYST (cyst in the brain) (seriousness criteria hospitalization and medically significant), BLINDNESS (lost his vision,) (seriousness criterion hospitalization), DIZZINESS (dizzy), PALLOR (turned white), SPEECH DISORDER (couldn't speak), FEELING ABNORMAL (felt something on his back (like a pull on his back)), EYE MOVEMENT DISORDER (eyes went back) and PAIN IN EXTREMITY (arm hurts towards his chest). At the time of the report, HYPOTENSION (Blood pressure under 40/60), CEREBRAL CYST (cyst in the brain), BLINDNESS (lost his vision,), DIZZINESS (dizzy), PALLOR (turned white), SPEECH DISORDER (couldn't speak), FEELING ABNORMAL (felt something on his back (like a pull on his back)), EYE MOVEMENT DISORDER (eyes went back) and PAIN IN EXTREMITY (arm hurts towards his chest) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Blood pressure measurement: 40/60 (Low) Low, 90/60 (Low) low and 150/69 (normal) normal. On 28-Apr-2021, Computerised tomogram: abnormal (abnormal) They found a cyst in the brain.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information was specified.; Sender's Comments: Very limited information regarding this events has been provided at this time. However,  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-2021-101752:
On April 9,2021, around 11:00 in the morning. I suffered an eposide of Transient global amnesia.  My husband notice I was unable to recall events from yesterday, asking repetitive questions of my daughter, I could not remember who the president is and  was unable to recall recent events.  I was admitted to the hospital for observation. CT head, and labs were ordered.  There were no evidence of intracranial hemorrhage, no evidence of CVA/TIA. I was treated for Transient global amenesia and released from the hospital on 4/11/201
Headache, Myalgia, NauseaVomiting, STATED ALSO EXPERIENCED CHILLS AND  PRESSURE IN EVES AND KNOT AT INJECTION SITE Narrative:  stated took OTC tylenol for headache and myalgias
Narrative:  POSITVE COVID TEST REPORTED BY PATIENT ON 4/9/21; RECEIVED 2ND PFIZER DOSE ON 2/16/21. MILD SYMPTOMS INCLUDE "RASPY VOICE, HEAD COLD, AND RUNNY NOSE". NO HOSPITALIZATION REQUIRED. Symptoms:  & PATIENT REPORTS "head cold, runny nose, raspy voice" Treatment: