chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. During 2012, the patient was inoculated at physician's office with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain condition of herpes zoster. On or about 09-MAR-2016, the patient was treated by a physician for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
blood pressure it's 126/88, pulse 99, and temperature 98.9, which is 3 points above normal/Had always had a really low pulse and wants to know whether this is normal or not; blood pressure it's 126/88, pulse 99, and temperature 98.9, which is 3 points above normal; blood pressure it's 126/88, pulse 99, and temperature 98.9, which is 3 points above normal; didn't eat his breakfast like he usually does; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 57 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Sep2021 13:00 (Lot number: FF2588) at the age of 57 years as dose 3 (booster), 0.3 ml single for covid-19 immunisation. Relevant medical history included: "galactosemia" (unspecified if ongoing); "a liver disease" (unspecified if ongoing); "immune system is compromised" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, lot number: EL9261), administration date: 15Jan2021, when the patient was 56 years old, for Covid-19 immunization; Bnt162b2 (Dose 2, lot number: EL9265), administration date: 05Feb2021, when the patient was 56 years old, for Covid-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious) with onset 28Sep2021, outcome "not recovered", described as "blood pressure it's 126/88, pulse 99, and temperature 98.9, which is 3 points above normal/Had always had a really low pulse and wants to know whether this is normal or not"; BODY TEMPERATURE INCREASED (non-serious), HYPERTENSION (non-serious) all with onset 28Sep2021, outcome "not recovered" and all described as "blood pressure it's 126/88, pulse 99, and temperature 98.9, which is 3 points above normal"; DECREASED APPETITE (non-serious) with onset 28Sep2021, outcome "not recovered", described as "didn't eat his breakfast like he usually does". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: History of all previous immunization with the Pfizer vaccine considered as suspect were none. Additional vaccines administered on same date of the pfizer suspect were none. The events did not require emergency room or physician office visit. Prior Vaccinations (within 4 weeks) were none. AE(s) following prior vaccinations were none. Family medical history relevant to ae(s): none. No problems with shots in past.   No follow-up attempts are possible. No further information is expected.
This may not be at all related to the Covid shot, but I am providing this data for informational purposes.  Five days after my second Covid shot, I had a hair cut and all was normal.  Four weeks later, when my hairdresser went to cut my hair he asked " have you changed your medication?" I asked why, and he said that I had developed several alopecia spots on the back of my head.  Another one developed on the top of my head three months later.  The dermatologist has been able to execute a standard protocol of cortisone injections to treat the alopecia and it seems to be working.  Again, this may not be related to the Covid shot but the timing is coincidental for this auto-immune event.
pt recv vax 22DEC97 & exp an increasingly sore arm assoc w/chills, fever & malaise for 24-36hr;tx initial rxn w/ice packs;over 72 hr erythema & swelling began to appear in rt forearm from elbow to wrist;pt arm red, warm & swollen;
Redness size of a quarter near injection site  Tenderness and pain with touch  Feels hard
This spontaneous report was received from a physicians assistant refers to a 38 year old male patient. The patient had no pertinent medical history and drug reactions or allergies. On an unknown date in 1997, the patient was intramuscularly vaccinated with a dose of VARIVAX (Merck), (lot number expiry date was not reported). No concomitant medications were reported. On an unknown date in 2011, the patient got varicella titer done and the titer was low so he received another dose of VARIVAX (Merck). Complete blood count was performed and the result was unknown. Additional information has been requested.
Patient received vaccine 1/25/2010 during physical around 9:30 AM - About 12 hrs later while in shower began feeling dizzy & fainted. Has mild nausea & headache now but no dizziness still.
No adverse event.  Expired # 2 HPV immunization given.  Re-given in 7 days.
administered dose of zosters and flu, unknowly recieved the week prior.  no initial or known adverse reaction
pt recv vax 26JUN96 & 23JAN96 pt devel papulovesicles;24JAN96 pt to MD w/10 papulovesicles;31JAN96 back to MD w/200 + lesions which were almost universally scabbed over/typical of varicella disease;full blown case chicken pox;
The side effects were horrendous; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (The side effects were horrendous) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 VACCINATION COMPLICATION (The side effects were horrendous). At the time of the report, VACCINATION COMPLICATION (The side effects were horrendous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Dec-2021: Follow up contains no new information
Patient states had increase shortness of breath on Saturday following her getting her H1N1 vaccine on Thursday. Has history of COPD. Her husband also had increase in shortness of breath on Saturday following his H1N1 on Thursday.
On dec 31 woke up with red, itchy bumps on knuckles. By end of night noticed knees were itchy with bumps and husband reviewed other joints finding itchy bumps on elbows toes and more bumps around hands. Took pictures  benadryl and went to sleep. Woke up Friday jan 1st noticed condition worsened as bumps were more red with prominent centers. Inside of fingers were painful to make fists. Went to urgent care prescribed pregnazone 20mg 2 times daily for 5 days, triamcinolone acetonide cream usp, 0.1% and instructed to get cetrizine hcl 10 mg. Took all and no relief by 5pm condition worsened and was still unbearbly itchy with sensitivity to warm water causing needlike pain.  Jan 2nd woke again condition spread and affected areas enlarged. Went to hospital er. Was told body is fighting something it will run its course. Told to followup with dermatologist. Jan 3rd still taking prescription with little effect raised bumps flattened but spread further and bruised appearance in center. Bottom of feet swollen and painful. Hand swelling started
Vertigo; Feeling dizzy all day; Vaccine the site stung lasting 20 seconds; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feeling dizzy all day), VACCINATION SITE PAIN (Vaccine the site stung lasting 20 seconds) and VERTIGO (Vertigo) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included OMEGA-3-ACID ETHYL ESTER (LOVAZA) for an unknown indication.    On 21-Apr-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced DIZZINESS (Feeling dizzy all day) and VACCINATION SITE PAIN (Vaccine the site stung lasting 20 seconds). On an unknown date, the patient experienced VERTIGO (Vertigo). On 21-Apr-2021, VACCINATION SITE PAIN (Vaccine the site stung lasting 20 seconds) had resolved. At the time of the report, DIZZINESS (Feeling dizzy all day) and VERTIGO (Vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication reported.    This case was linked to MOD-2021-225561 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: significant follow up appended. event vertigo added.
soreness in arm Chills, fever, body aches, swollen lymph nodes began about 12 hours after the shot and continued for 36 hours.    Headache 36 hours
Patient requested Pfizer Bivalent vaccine and was given Pfizer Monovalent Vaccine. There are no adverse events to report at this time.
Patient stated that she was itching and burning on her skin.  Started on lower left arm, spread up arm to face and neck, then continued to spread over body.  Reaction started roughly 25 minutes after vaccination.  Gave 25mg benadryl immediately (patient declined 50mg), then gave another 25mg 5 minutes later after no improvement.  Roughly 40 minutes after immunization, patient reported rapid heart rate.  Heart rate was ~105.  Symptoms began to improve roughly 30 minutes after benadryl administration.
SICK 4 TO 5 TIMES SINCE RECEIVING THE JNJ VACCINE; COUGH; DIARRHEA; HEADACHE; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: 14-DEC-2021) dose was not reported, administered on 26-OCT-2021 for prophylactic vaccination. Age at time of vaccination 55 years old. No concomitant medications were reported. On 05-MAY-2022, Laboratory data included: COVID-19 virus test (NR: not provided) negative. On an unspecified date, the patient experienced sick 4 to 5 times since receiving the JNJ vaccine, cough, diarrhea, headache, and low grade fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Low grade fever (Low grade fever). Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and had not recovered from sick 4 to 5 times since receiving the JNJ vaccine, cough, diarrhea, and low grade fever. This report was non-serious.
Developed a cough and difficulty breathing. Began to feel ill with mild joint ache and nausea. Condition started about 3 hours after the injection. Breathing returned to normal but the ill feeling and nausea continue now 20 hours later.
Patient had a golf ball diameter sized welt at the injection site, which was warm to the touch, and felt achy for a few days.
chills; felt awful; felt sick to my stomach; tired; Itching at the site; I had a hard time breathing; asthma to flare up; anxiety; This case was reported by a consumer via call center representative and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included asthma.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, feeling abnormal, upset stomach, fatigue, injection site itching, difficulty breathing, asthma aggravated and anxiety. On an unknown date, the outcome of the chills, feeling abnormal, upset stomach, fatigue, injection site itching, difficulty breathing, asthma aggravated and anxiety were unknown.   It was unknown if the reporter considered the chills, feeling abnormal, upset stomach, fatigue, injection site itching, difficulty breathing, asthma aggravated and anxiety to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication.  The patient received Shingrix vaccine and felt awful, sick to stomach tired, chills, Itching at the site, hard time breathing, causing asthma to flare up and it could had been patients anxiety. The patient was not sure if he/she should get the second dose.
Patient was found dead in the yard of his residence.  He laid in the yard for a couple of days before he was discovered.  No further information was provided by the family.  His wife lives with him in the home; however, she is disabled and unable to provide any information.
Approximately 15 minutes after having the COVID-19 Pfizer vaccine shot I began experiencing a non-severe allergic reaction of itching in my arms chest stomach neck area as well as my pubic area. This itching has been nonstop, daily, since I was vaccinated on April 18, 2021.
Rash started 11/18 evening on abdomen. 30-40 papules on abdomen/groin (red macules with papules in center - pruritic).
Information has been received from a certified medical assistant concerning a female reportedly in her 70's who was vaccinated with 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot 650084/0605P). Concomitant therapy included an unspecified blood pressure medication .Subsequently the patient developed swelling and redness at injection site. The patient sought unspecified medical attention. Subsequently, the patient recovered from swelling and redness at injection site. The reporter indeicated the something must be wrong with the lots since the patient was vaccinated before without any problem. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. the lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Pt received vaccine at 10:10 AM, at 10:22 AM pt then reported some itchiness and hives to bilateral hands. The observation nurse alerted staff. Pt reported her throat also felt itchy, initially denying any feelings of SOB or difficulty breathing. Pt BP taken at 10:22 AM 168/84. 50 mg Benadryl administered IM to R. deltoid. Pt then began stating that she felt difficulty breathing. At this time 0.3 mg Epi administered to r. thigh. EMS was called and en route during this time. Blood pressure taken multiple times and remained hypertensive. EMS arrived at 10:32 AM. Pt vitals 98% oxygen on room air, PR 67 96.9 temp, 20 RR 152/82. Pt then transported by EMS to local hospital.
Mom called 11/10/09 to report adverse reaction pt vomited 5 times 11-9 9:30 pm - 11-10 4:30 am. 11/10: mom reported daughter did not have fever and was feeling better. Mom RQ we report this reaction.
Headache, Myalgia, Arthralgia, Fever & Rash Narrative:
Patient experienced a rash that presented on the vaccinated arm. The rash spread to a little above the vaccination site to just below the elbow. The rash was itchy and was described as "hives".
His whole left tricep is red and warm. Started small on 8-11-14 and has gotten bigger. He is going to a walk in clinic this morning after a dose of diphenhydramine.
Started with chills, fever ,Nausea aches and pains for 2 days went into full sinue infection, weal and its been 5 days,
severe reaction to the second dose; felt horrible for three days; headache; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (severe reaction to the second dose), FEELING ABNORMAL (felt horrible for three days), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first 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 (severe reaction to the second dose), FEELING ABNORMAL (felt horrible for three days), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills). At the time of the report, VACCINATION COMPLICATION (severe reaction to the second dose), FEELING ABNORMAL (felt horrible for three days), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-399754 (Patient Link).   Reporter did not allow further contact
Severe pain in Right shoulder and inability to move arm more that 10 degrees with shoulder flexion of abduction, nausea, vomiting, dizzy (beginning to pass out), chest pain, temp over 102, severe headache
red patches on stomach that are extremely itchy; itching area in arm; skin rash; Swollen hot; hot to the touch in area of arm; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to the touch in area of arm), PAIN IN EXTREMITY (Pain in arm), ERYTHEMA (red patches on stomach that are extremely itchy), VACCINATION SITE PRURITUS (itching area in arm) and VACCINATION SITE RASH (skin rash) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044821A and 037132AA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Eczema and Back distress. Concomitant products included TRIAMCINOLONE and MELOXICAM for an unknown indication.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 21-Mar-2021, the patient experienced VACCINATION SITE WARMTH (hot to the touch in area of arm), VACCINATION SITE PRURITUS (itching area in arm), VACCINATION SITE RASH (skin rash) and VACCINATION SITE SWELLING (Swollen hot). On 09-Apr-2021, the patient experienced ERYTHEMA (red patches on stomach that are extremely itchy). At the time of the report, VACCINATION SITE WARMTH (hot to the touch in area of arm), PAIN IN EXTREMITY (Pain in arm), ERYTHEMA (red patches on stomach that are extremely itchy), VACCINATION SITE PRURITUS (itching area in arm), VACCINATION SITE RASH (skin rash) and VACCINATION SITE SWELLING (Swollen hot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was given.   This case was linked to MOD21-074447, US-MODERNATX, INC.-MOD-2021-075201 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Follow up  information on 13-APR-2021 include patient's Date of Birth, medical history(Eczema, back problems). Administration of Moderna vaccine second dose was added. Concomitant product information (triamcinolone cream, meloxicam) were added. Events erythema,Skin rash,  vaccination site swelling were  added. Event sore arm was upgraded to pain in arm . Date of reaction start were added.; Sender's Comments:  MOD21-074447:1st dose US-MODERNATX, INC.-MOD-2021-075201:1st dose
Breakthrough COVID-19 infection. Pt received Moderna on 1/19/21 and 2/16/21
Information has been received from a physician concerning a 65-year-old male who was vaccinated on an unspecified date with a dose of Zostavax. Subsequently, on an unspecified date, the patient was admitted to the hospital with chicken pox. It was determined that the patient had "symptoms associated with acute varicella and not shingles." No outcome was reported. No product quality complaint was involved. Additional information has been requested.
Patient received FLUZONE Influenza and Pneumococcal-23 vaccines on 09/08/17. That evening patient started to experience arm started hurting and bruising and getting flu like symptoms. Saturday and Sunday right arm was swollen, hot, and bruised. 09/11/17 right arm hot, itchy, and really red but not feeling ill any longer. Arm still tender. Pt had had Influenza vaccine in the past but not a Pneumococcal-23 vaccine before. Pt was seen in the office on 09/12/17 and determined that right arm was red, swollen and feverish. DX: Allergic reaction to drug at injection site. Pt given BENADRYL and ZYRTEC to help with reaction.
Delayed rash on arm at injection site. On the 8th day following vaccination, I developed a circular red rash, slight swelling, hot, vaguely itchy.  The circle was about 2 inches diameter.  Over the next two days, although the swelling abated, the rash expanded down and around my arm. I am now in my third day of having the rash. Now , the rash is about 6 inches down my arm  Like her, I am wondering whether I should have the second dose of the vaccine.
lt arm pain since DT administered on 2JUN95; dec sensation over 2nd & 3rd digits of lt hand; no fever, local swelling; tx NSAIDS, heat, referral to PT
This spontaneous report was received from an unknown reporter via a company representative, referring to a male patient of unknown age. The information regarding the patient's medical history, concurrent conditions or concomitant medication was unknown by the reporter. On an unspecified date, the patient received an injection of PNEUMOVAX 23 (strength, route, dose, lot # and expiration date unknown by the reporter) for prophylaxis. On an unspecified date, the patient had a "significant injection site reaction to PNEUMOVAX 23 and sought medical attention" (injection site reaction). It was reported that the patient received treatment for the event, it was unknown by the reporter if the patient had any lab diagnostics/studies performed. The outcome of the event and the causality assessment between the event and the PNEUMOVAX 23 was not reported.
Shortness of breath, lack of taste and smell, coughing up blood and headaches. Having muscle and joint pains.