chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a 45 male patient refers to himself. There was no pertinent medical history and drug reaction or allergies. On 31-JAN-2014 the patient was vaccinated by his physician with the first dose of RECOMBIVAX HB (injection, strength: 10mcg/l ml, intramuscular, dose: 1 ml, lot#: J006511 expiration date: 26-JAN-2016) for prevention of infection caused by all known subtypes of the hepatitis B virus. On 03-MAR-2014 the patient was vaccinated by his physician with the second dose of RECOMBIVAX HB (injection, strength: 10mcg/1 ml, intramuscular, dose: 1 ml, lot# reported as: J012565, expiration date reported as: 03-FEB-2016) also for prevention of infection caused by all know subtypes of the hepatitis B virus. There was no concomitant medications. On 31-JAN-2014 the patient experienced dizziness for "about a week" (reported also as: starting immediately after the injection). On 06-MAR-2014, the patient experienced muscle pain and weakness throughout his whole body (reported also as beginning "about three days" after the second injection). The patient reported that muscle pain felt like "after heavy workout" describing it as pain was felt more intensely while moving his arms and legs. The patient also stated that "any normal muscle pain would last longer than normal like upwards of a week". There was computered tomography (CAT) scan performed in approximately June 2014 (reported as: "2 to 3 months ago") but the results were not provided. The therapy with RECOMBIVAX HB was discontinued on 03-MAR-2014 and the patient did not recover from the events of muscle pain and weakness throughout his whole body. The patient's condition did not improve. The outcome of he experienced dizziness for about a week starting immediately after the injection was recovered/resolved. There was no treatment given for the reported events. The patient sought medical attention in approximately September 2014 (reported also as "about week ago") by returning to his physician who referred him to the rheumatologist. The relatedness between the events and the therapy with RECOMBIVAX HB was not reported. Additional information has been requested.
RAISED INDURATED AND ERYTHEMATOUS. AREA 5CM BY 10CM STARTING AT INJECTION SITE AND EXTENDING DISALY
Early morning after 2nd vaccination, 2/19/21),  patient was what is best described as in a comatose type state.  Symptoms where unresponsiveness, fever (101 degrees), unable to eat, drink or open eyes.  Was able to suck on a washcloth.  The following day, 2/20/21, same symptoms as day before but fever went down.  Took blood sugar in the morning and it was good.  Was able to give minimal liquids by a bottle.  Got about 4 ounces of water in about 2 days.   On 2/21/21 around midday patient was able to get out of bed and was on way to recovery.
Patient says shot was painless and in the right location but 2-3 days starting having troubles with range of motion in right arm. Pain localized to injection site. has not got better. can left a shopping bag but opening a car door is difficult.
fever of 101 degrees, sore deltoid sites, especially the dtap site(left)
Awoke feeling cold, shivering uncontrollably.  Low grade fever (99.7) despite taking 2 ibuprofen 2 hours earlier at bedtime due to arm soreness.  Chills and shaking continued for 30 minutes until falling back asleep.  Awoke 2 hours later feeling warm, 101.4 fever.  Blood pressure (138/84) and heart rate (106) elevated.  Similar experience to fall 1976 reaction to the Swine Flu Vaccine administered .
achy; headache; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy), HEADACHE (headache) and MYALGIA (muscle pain) 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 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (achy), HEADACHE (headache) and MYALGIA (muscle pain). At the time of the report, PAIN (achy), HEADACHE (headache) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: TCR: not interested in follow up.
First one was fine but the 2nd caused what we believe was likely myo or pericarditis. I had pretty extreme SOB, chest pain, exhaustion and collapsed on the floor several times because I was too weak to make it around the house. It started with bizarre heart rate and blood pressure spikes and drops immediately after the vaccine and the carditis like symptoms started about 3 days after that. To this day I have not regained my cardio capacity. I only returned about 60% of what I used to have despite a year of trying, I saw a cardiologist 4 months after this happened (soon as I could get in) and he told me I probably had a small amount of permanent damage and there would be no telling what I may ever recover.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 62-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received in July 2018). In January 2019, the patient received the 2nd dose of SHINGRIX. In January 2019, 1 day after receiving SHINGRIX, the patient experienced fever, chills, fatigue and pain in arm. In January 2019, the outcome of the fever, chills, fatigue and pain in arm were recovered/resolved. It was unknown if the reporter considered the fever, chills, fatigue and pain in arm to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's wife. Approximately 24 hours later receiving SHINGRIX, the patient experienced arm soreness, fever, chills, shivering, and fatigue. The symptoms lasted for about 3 days and have resolved. The reporter did not consent to follow up. This case has been linked with case US2019019126, reported by the same reporter.
30 days after second injection, an unusual amount of hair loss began (Apr 7, 2021)
She reports that symptoms started about 30 minutes after the injection. She reports feeling dizziness, loss of balance, headache, muscle twitches in her arms, and nausea that worsened that evening and continued into the next day. She had to miss work due to symptoms. Her symptoms had "lessened" 2 days later.
This spontaneous report as received from a retired nurse refers to a female patient of unknown age, her friend. Pertinent medical history, concomitant medication, drug reactions and allergies were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot number and expiration date were not reported). On approximately 07-APR-2014, reported as about one week ago, the patient was diagnosed with shingles "all over her trunk". The outcome of shingles "all over her trunk" was unknown. The patient sought unspecified medical attention. The relatedness between event and ZOSTAVAX was not reported. The reporter also noted that she had an unspecified reaction to an unspecified chemotherapeutic agent. Additional information has been requested.
I had much pain on the arm I got the flu shot for more than two weeks. The area around the shot was very red and hot for more than a week. I felt sick and woke up in the middle of the night because my arm was in pain and it was really hot.
Lightheaded, dizzy, nausea, pale. Immunization at 14:12, S & S at 14:20. Client had not had meal for 18 hours. Reaction followed Plasma donation of 880 ml. Feet elevated, cold compress, fruit juice, 200 ml. when VS stable. Recovered in approx. 20 min.
05/14/2022 I had my second booster. 05/15/2022 I started to experience COVID like symptoms 10 hours later. I had general body /aches, 101 body temperature to include flu like symptoms. Spoke to my doctor in 07/2022 because I had an upcoming appointment. The doctor said to go to the emergency room to get tested. I tested positive for COVID-19. The hospital gave me an antibiotic monoclonal antibodies. The symptoms lasted for 36 hours, temperature 101.5 and fluctuated.
Late at night patient began having chills and extreme muscle pain all over her body, sore throat, nausea, extreme fatigue. She also had a fever of 102.
Patient got COVID in Mar 29, 2022. since the last Booster. It started with a chest cold and congested in chest and lungs. It felt like Bronchitis. I had full body aches and headaches. I had throbbing pain in my heart area. I could not walk around because of shortness of breath. The congestion was really bad that I started feel nausea and I started vomiting and diarrhea. I had problem moving around after that. I had tinnitus (ringing in my ear.) I had vertigo very bad. I had it so bad that I had to crawl on the floor to vomit's in the bathroom. I had very bad body sweats and chills. I could go up the stairs or down the stairs to my house because I was so weak. I was going to call an ambulance but I didn't have my phone. I was very severely affected by the vertigo. And even after two weeks I can barely walk to kitchen and chair because of the weakness and body ache and shortness of breath. I can't even leave my house because of the shortness of breath. I dizziness and vertigo continues even after 2 week of contacting the virus. Even Apr 21, 2022 I can't go half a block with sitting down because of shortness of breath and can't breath. This is not a mild case. This is a really severe case and if I didn't have a vaccine or booster I would have been in the hospital. I am pretty sure I got COVID from my 6 year old daughter after mask was lifted and not mandated. I didn't see a doctor. I ached so much and stayed home and quarantine.
After my second Pfizer vaccine on April 8, 2021 at 10:45 AM I had no issues until approximately 11:00 PM that evening where I experienced a fever and extreme nausea. I threw up constantly through the night and shivered with a fever of 102-103. I?ve continued to run a fever of 99.9 -100.7 as I am making this report on April 10,  2021.
Shortly after receiving Defendants' Zostavax vaccine, Plaintiff suffered shingles and retinal damage.; Shortly after receiving Defendants' Zostavax vaccine, Plaintiff suffered shingles and retinal damage.; Information has been received from a lawyer and the patient (pt) regarding a case in litigation involving a female patient (pt) of unknown age. No information about the pt's pertinent medical history, concomitant medications and drug reactions or allergies was provided.     In or around May 2012, the pt was inoculated with a dose of zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, route, frequency, lot/batch # and expiration date were not reported). Shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered shingles (herpes zoster) and retinal damage (retinal injury). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using it. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution, and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.   The reporter considered the events to be related to zoster Vaccine Live (ZOSTAVAX).  The reporter considered the events to be disabling.  Upon internal review, retinal injury was determined to be a medically significant event.
Redness around injection site and itching the day of vaccine, redness around injection site but no itching day 2 and 3 after vaccine.
11 days p/vax a cluster of 5 pox started @ the site of inj;5 more appeared over body & lasting 4-5 days;no complications;
uncomfortable rash; Lichen Sclerosus. An autoimmune disease; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Sep2021 as dose 3 (booster), single (Lot number: FC3184) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Colon resection", start date: 2007 (unspecified if ongoing), notes: Colon resection. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EN6205, Location of injection: Arm Left), administration date: 08Mar2021, when the patient was 67-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EN6200, Location of injection: Arm Left), administration date: 15Feb2021, when the patient was 67-year-old, for Covid-19 immunization.  The following information was reported: LICHEN SCLEROSUS (non-serious) with onset 21Jan2022, outcome "not recovered", described as "Lichen Sclerosus. An autoimmune disease"; RASH (non-serious) with onset 21Jan2022, outcome "not recovered", described as "uncomfortable rash". The events "uncomfortable rash" and "lichen sclerosus. an autoimmune disease" required physician office visit. Therapeutic measures were taken as a result of rash, lichen sclerosus.  Additional information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Prior to vaccination, was the patient diagnosed with COVID-19? No. Since the vaccination, has the patient been tested for COVID-19? No. Clobetasol ointment after Lichen Sclerosus diagnosis.  No follow up attempts possible. No further information is expected.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021 at 2:42 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Oct-2021 at 2:05 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 81.93 for dose administered on 14-Feb-2021 and 82.61 for dose administered on 22-Oct-2021.  No concomitant medications were reported.  Batch number 031L20A underwent temperature excursion on 14-Feb-2021 with temperature range 32 to 35 degrees Fahrenheit from 09:00 AM to 03:00 PM. This vial was moved to fridge on 09-Feb-2021 and vaccine BUD date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-Jan-2021.  Batch number 035C21A underwent temperature excursion on 22-Oct-2021 with temperature 32 degrees Fahrenheit from 08:00 AM to 10:00 AM. This vial was moved to fridge on 29-Sep-2021 and vaccine BUD date for the vial was reported as 29-Oct-2021. Product moved to clinic on 22-Oct-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment medications were reported.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 87-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Concomitant products included fluticasone propionate, salmeterol xinafoate (Advair). On 7th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 µg. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 7th September 2018, 123 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the patient experienced scar, pain of skin and incomplete course of vaccination. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the scar and pain of skin were not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the shingles, scar and pain of skin to be related to SHINGRIX. Additional information received as follows: The case was reported by the patient's wife. The patient had 10 dime sized scars on his back and he continued to had pain in his abdomen area where the shingles were. The patient was taking Advair about twice a week because of the pain and he does not usually use pain relievers at all. The patient had not gotten his 2nd dose of SHINGRIX till the reporting time, which led to incomplete course of vaccination.
pt was one of two pt who had a large localized rxn & inj site;pt w/ 6" area redness & swelling;
Shortness of breath, 90 O2 SAT, headache, puffiness (3-12 hrs).
May 11th had the worse headache of my life. Went to ED. CT scan showed  SAH in right frontal/parietal regions. MRA showed multifocal venous sinus thrombosis. Partial thrombosis of superior sagittal. Heparin gtt and sent home on Lovenox BID
calling for temperature evaluation for VARIVAX and notifed it was administered to multiple patients; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 13-APR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX)(strength, dosing schedule, lot#, expiration date and route of administration were not provided) for prophylaxis. Administered dose of vaccine was exposed to the temperature from -14 Celsius degrees to -10 Celsius degrees for 4 hours 15 minutes. There was a previous temperature excursion noted: from -9 Celsius degrees to 8 Celsius degrees for 2 hours 21 minutes, as recorded by a digital data logger.  This is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2007USA003458:
Approximately three minutes after administering the vaccine we heard the patient's mother speaking her name several times with no response. One of the technicians was in the area and observed her with her arms tucked in front of her and her feet were moving back and forth in a repetitive motion with her eyes rolled back. After a few seconds she ceased that and said "I was sleeping" We called 911 and EMS came to check her out
This spontaneous report was received from a nurse refers to a unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of RECOMBIVAX HB (strength, route of administration, dose and lot # were not reported). It was reported that the vaccine was not monitored for unspecified period of time and there were no temperature logs available. The reporter was not aware of any adverse experiences at the time of the report. This is one of several reports receivd from the same reporter. Additional information has been requested.
Positive test for Covid 19 on January 27, 2022.  Place of infection not traceable; I had traveled cross country helping my son move.  Masks were worn if around others at all times.  Son tested negative.  Did a televisit with my doctor for advice and instruction.  Relatively mild infection; did not lose taste or smell; slept a lot; used Mucinex and Tylenol at doctor's instruction.  Fine after 5-6 days.
Patient felt flushed with tenderness at the vaccine site.  Patient remained under observation for 1.5 hrs and then felt well enough to leave without further care.
Vaccine was given very high on the arm/shoulder and  missed the deltoid.  Pain in shoulder joint from the beginning and getting worse over the months, including reduced range of motion.  MRI results indicated inflammation and adhesive capsulitis.  Ongoing treatment with physical therapy and soon to schedule a cortisone shot.
Narrative:  Patient had three Pfizer COVID 19 Vaccines (Jul,Aug 2021, and Jan 2022). The patient tested positive for COVID 19 on 28 April 2022. The patient presented to the ED with shortness of breath. The patient was admitted to the hospital with respiratory failure and hypoxia with COVID, but also severe COPD exacerbation. The patient was treated with inhalers and steroids. The patient was discharged on 29 April 2022. The patient presented to the ED on 15 May 2022 with another acute exacerbation of COPD with cough and congestion. The patient was treated with steroids and inhalers. Reported per EUA.
Severe migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Severe migraine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Severe migraine). At the time of the report, MIGRAINE (Severe migraine) outcome was unknown.            No treatment medication was reported.  OTC drugs taken were Tylenol and Somatropin.
Pt recv vax on 12/27/97; on 12/29/98 pt exp leg edema; tx=Diphenyldronise
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in November 2018, between 02-NOV-2018 and 16-NOV-2018, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (Oka/Merck) subcutaneously (dose was not provided, lot# R018144, expiration date 25-JUN-2020) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No adverse effect. The digital data logger was involed. The vaccine experienced temperature excursion between 15 degrees Fahrenheit to 46 degrees Fahrenheit (15.1 degrees Fahrenheit) for 1 hour. There were no previous temperature excursions. This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1811USA009261: US-009507513-1811USA009257: US-009507513-1811USA009258: US-009507513-1811USA009259: US-009507513-1811USA009260: US-009507513-1811USA009255: US-009507513-1811USA009256: US-009507513-1811USA009254: