chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles; Information has been downloaded from Agency (US-BEH-2014047225).   This spontaneous report was received from a healthcare professional and refers to a 63 year old female patient. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided.      On 16-SEP-2014, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX), subcutaneously, for prophylaxis (strength, dose, frequency, lot number and expiration date were not provided). On the same date, the patient was also vaccinated with a dose of influenza virus split virion 3v vaccine inactivated (AFLURIA) (Lot # T58706), via intramuscular, for prophylaxis (strength, dose, frequency, lot number and expiration date were not provided).   On 23-SEP-2014, the patient experienced shingles (herpes zoster).     At the time of reporting, the outcome of herpes zoster was reported as resolved on an unknown date.      The causal relationship among zoster vaccine live (ZOSTAVAX), influenza virus split virion 3v vaccine inactivated (AFLURIA) and the reported herpes zoster was not provided.  The reporter considered the herpes zoster as serious, medically significant.
Dose administered after more than 1 temperature excursion; Dose administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursion) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 8:39 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 8:39 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported age 80.92. No concomitant product use was reported.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  On 17-Feb-2021, Excursion time at 9 am, temp 22, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 11-Feb-2021, vial was moved to clinic on 17-Feb-2021. 5 vials were moved to clinic. Vaccine BUD date was 13- Mar-2021 for batch number 022M20A.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. Storage condition at the time of the excursion was reported as cooler storage during high-pace COVID-19 vaccination clinic.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
pt eval @ ER for high fever 105; also pt was prev dx URI 8NOV91 @ clinic; pt given meds;
I took the shot at 6:00P.M. at 6:10P.M. I started feeling a pain running from the shot site down to the bend in my arm, then it radiated down my lower arm to my wrist. I kept feeling it and at 6:15P.M. I started feeling lightheaded and  had the sensation I was going to faint. I notified the attendant and she and some other nurses came to my assistance and lowered me to the floor and raised my legs above my head.  They took my blood pressure and it was low as was my pulse, but my oxygen was 100%. i kept deep breathing as per their request. After a little bit i started to come to my senses and they gave me water.  I was difficult to swallow, my throat felt unusual. After about five minutes my swallowing got back to normal. The pain was still radiating from the shot site to my wrist. I stayed there till 6:50P.M. I felt better but on my way home the pain was still going down my arm.  About 8:00P.M. my left upper hand stated to hurt, then my thumb, index and middle fingers stated tingling.  That happened on and off through the evening.  At 12:00A.M i went to bed. On and off through the night I still had the pain and tingling in my arm and hand.  About 3:00A.M. I woke up and my arm and ring finger and little finger were numb like they fell asleep.  I raised my arm and the feeling slowly went away.  Throughout the day an 01/21/21 my arm was very sore by the injection site. Other than that nothing else has since occurred.
Swollen tender muscle at injection site - worsened 10-12 days after injection. Similar reaction at 15 months Hep A vaccine (in leg).
Only adjuvant administered; Only adjuvant administered; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate dose of vaccine administered in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number XL7RB, expiry date 05-AUG-2024) for prophylaxis.   On 28-MAR-2023, the patient received the 1st dose of Shingrix (left arm). On 28-MAR-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: Only adjuvant administered) and inappropriate preparation of medication (Verbatim: Only adjuvant administered). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK Receipt Date: 18-APR-2023 The reporter reported regarding the maladministration of the Shingrix adjuvant to the patient. The sales rep shared HCP´s contact information and mentioned that HCP wanted to know when they could give a proper reconstituted dose of Shingrix. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Ten days, post vax, the pt developed a notable generalized red measles rash with fever. Febrile seizure X 1.
I heard gurgling in my lungs followed by wheezing almost like an asthma attach; I heard gurgling in my lungs followed by wheezing almost like an asthma attach; I heard gurgling in my lungs followed by wheezing almost like an asthma attach; Vomited heavy mucus; This is a spontaneous report from a contactable other healthcare professional (patient). A female non-pregnant patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3302), via an unspecified route of administration in arm left on 01Feb2021 at 15:30 as a dose 1, single for COVID-19 immunization. The patient's medical history was reported as none. The patient had no known allergies. The patient's concomitant medications in two weeks were reported as no. The patient was not pregnant at time of vaccination. Other vaccine in four weeks was reported as no. No covid prior vaccination and no covid tested post vaccination. It was reported that, the patient received her first vaccine on 01Feb2021. On 10Feb2021 at 12:00 AM, the patient vomited heavy mucus. The next morning on 11Feb2021, the patient heard gurgling in her lungs followed by wheezing almost like an asthma attach, that lasted for 1 day. On 12Feb2021, she was perfectly fine. Stated that, was it possible to get a reaction 10 days after the vaccine. Should she get the second vaccine. Treatment was not received for the events. The outcome of the events was recovered on 12Feb2021.  Follow-up attempts completed. No further information expected.
Developed urticaria over face & anterior & posterior trunk. Diphenhydramine 18.75 mg given PO x1 immediately after hives developed. Hives resolved after 30 minutes.
Short of breath with physical exercise. At the age of 23 diagnose with major heart condition, block arteries.
w/in 24hr  of vax pt devel an inj site rxn characterized by an area of redness & heat the size of a cup;then devel myalgia & arthralgias & then a fever;pt was seen by MD who dx a resp infect & prescribed med;pt recovered;
9 days later the site of the injection is red and warm and irritated. It seems to be a red warm rash at injection site
Headache, pain where the vaccine was inoculated, tiredness/fatigue, pain in the back
Triggered severe Ramsay Hunt flare-up - floating H/A, pain eyes, blisters face, Rt neck hardened, decreased ROM, lethargy and fatigue; invaded blood vessels brain - severe livedo, decreased mental function, abn gait, loss core strength.
Janssen COVID-19 Vaccine EUA I developed severe chills (no fever) 8 hours after receiving the vaccine.  Taking Aleve helped to ease the chills.  For the next 6 days, I had a headache, flu-like symptoms, light-headedness and nausea.  Four days after receiving the vaccine, I had a nose bleed, which is a very rare occurrence for me.
2 weeks after receiving meningococcal, smallpox and anthrax #2 vaccines, the patient experienced the onset of chronic shoulder (L>R) and elbow arthralgias.  He also developed palpitations, without chest pain, with strenuous aerobic exertion.  The palpitations consisted of a sense of his heart rate increasing sooner than normal in a workout, taking longer to return to normal after the workout and reaching rates higher than would be expected for the level of the workout.  The above complaints lasted 3 months with gradual improvement and were completely resolved by Jan 2005 with no recurrence.  He had received meningococcal vaccine also 10 Aug 95 without adverse reaction and received anthrax #2 14 Oct 04 with no increase in the symptoms that he had already started to experience 2 weeks after the 24 Sep 04 vaccinations.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-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), in Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 51 years, in left arm 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), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: COVID 19 Treatment. Therapeutic measures (Paxlovid therapy start date: 06Nov2023, therapy stop date: 10Nov2023) were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300380580 as same patient, different drug/event.;
16:21PM Pt stated she was unable to get up and exit due to being "really dizzy"  No other signs /symptoms stated 16:39PM Pt states "feeling a lot better" HR: 78 BP:98/56 SO2 RA 97%
myopericarditis; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myopericarditis) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: (Privacy)    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, the patient experienced MYOCARDITIS (myopericarditis) (seriousness criterion hospitalization). The patient was hospitalized for 1 day due to MYOCARDITIS. At the time of the report, MYOCARDITIS (myopericarditis) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (myopericarditis) to be related.    No concomitant and treatment medications were reported.  Patient's age was reported to be between 18-24 years  Company comment: This is a literature-non-study case concerning a adult female patient of unknown age with no reported medical history, who experienced the expected, serious, AESI event of myocarditis. The event myocarditis exact occurrence unknown but stated that the event occurred after the second dose of mRNA-1273 vaccine administration and resulted to hospitalization. No reported treatment information. The outcome of the event myocarditis was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-469162 (Patient Link).; Sender's Comments: This is a literature-non-study case concerning a adult female patient of unknown age with no reported medical history, who experienced the expected, serious, AESI event of myocarditis. The event myocarditis exact occurrence unknown but stated that the event occurred after the second dose of mRNA-1273 vaccine administration and resulted to hospitalization. No reported treatment information. The outcome of the event myocarditis was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Patient is immunocompromised and was supposed to be getting 0.5 ml of Moderna (lot# 012H21B) but instead she was given a booster of 0.25 ml
Immediately following the injection I experienced a sensation running through my arm that persisted for about an hour. Then the next day I experienced a pretty strong headache and some fatigue. These initial systems went away within a day or so, then about one week later, I experienced chest tightening and floating black spots in my periphery vision. I went to the doctor and he said it was part of my body's natural immune response. The chest tightening/cardiac inflammation eventually subsided several months after receiving the vaccine but I still have black spots floating in my periphery vision. Additionally, in the weeks that followed the vaccine I experienced a dramatically degraded immune system where I got sick two different times in one week and then a third time a week or so later (since then my immune system has improved back closer to normal). This is VERY abnormal for me because under normal circumstances I almost never get sick. These are new conditions that I did not have prior to getting the vaccine. NOTE: because I work for the DoD, I was required to get the second dose of the COVID-19 Vaccine or face disciplinary action up to termination from employment (a career I have worked in for over 15 years).
Every night I was having difficulty sleeping waking up choking. And when I was sleeping I was awake. I was having such difficultly sleeping that I was nodding off while driving. And doctor ordered a sleep study. I was diagnosed with sleep apnea. I had no symptoms the month prior to having COVID and then started having difficulty sleeping. I let it go on for a while before going to the doctor. I also had adverse reaction to the injection site being painful and the swelling went under my arm to my breast muscle and I couldn't lift it for 2 days. I had a 101-103 fever for 2 days. The 3rd morning I was regular temperature. Besides the nausea and dizziness that was about all the reaction.
Mom states approx. 7 hrs. after receiving shots, her daughter started having seizures.  Mom states her daughter suddenly started twitching and shaking.  She was staring out the window and did not respond to her name.  Mom called 911 and child was transported to hospital.  Mom states temp @ hosp was 104.2 and they told mom that the child had been seizing for an hour.  They put child on a heart monitor, IVs and oxygen.  Tylenol and Motrin were adm.
Patient stated that his arm is very sore. He also stated that he has been disoriented and experiencing headaches and dizziness.
Patient reported on 11/09/2010 that she felt pain during injection (not usual burning sensation) and resulting pain from injection site across shoulder into neck and down arm. 11/10/2010 Patient reported symptoms diminished slightly. Had contacted PBP and was encouraged to treat with ice or heat and call if symptoms worsen.
Headache, Myalgia, Fever, chills and fatigue Narrative:  Other Relevant History:
Information has been received as part of a class action suit concerning a pregnant female patient who was vaccinated with a dose of hepatitis B immune globulin. Subsequently, her son experienced toxic neurologic effects of mercury poisoning. Outcome is unknown. Toxic neurologic effects and mercury poisoning were considered other important medical events (OMIC). No additional information was provided. This report was received from the manufacturer's legal department on 12/13/04.
Vaccine given at day 74 of storage in refrigeration temperature.  (4 days after advised expiration)
shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to an 73-year-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 28-OCT-2016, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) in the pharmacy for prevention of shingles. As a result of administration of zoster vaccine live (ZOSTAVAX), from an unknown date (reported as within three months after receiving the vaccine) she was caused to suffer shingles, including any and all of its sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX), and as a result of her receipt of zoster vaccine live (ZOSTAVAX), the patient had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions she required and/or would require more health care and services and did incur medical, health, she would in future be required to obtain further medical and/or hospital care, attention and services. The outcome of the event was reported as not recovered. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was considered to be disabling by the reporter.
Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A 59-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 59 years as dose 2, single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown) for COVID-19 Immunisation. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "Nausea".  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
- Chills and shaking (severe) - Bloodshot eyes, slight hypersensitive eyes - Dry throat, felt like dry lump in throat - Loss of balance - Headache (moderate to mild) Overnight bed rest seemed to temper most symptoms to mild or tolerable. About 40 hours after shot, slight eye irritation and slight headache only.
Dermatographic urticaria on "my" torso and neck; The region will be itchy and when "I" scratch it, it raises into welt like hives where "my" nails were; The region will be itchy and when "I" scratch it, it raises into welt like hives where "my" nails were; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 16Apr2021 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included generalized anxiety disorder, seasonal affective disorder and allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included spironolactone (MANUFACTURER UNKNOWN), fluoxetine hydrochloride (PROZAC), colecalciferol (VITAMIN D3) and cyanocobalamin (VITAMIN B12); all for unknown indications from unknown dates and unknown if ongoing. The patient previously took amoxicillin (MANUFACTURER UNKNOWN), azithromycin (ZITHROMAX), minocycline (MANUFACTURER UNKNOWN), doxycycline (MANUFACTURER UNKNOWN), sulfamethoxazole/trimethoprim (BACTRIM) and erythromycin (MANUFACTURER UNKNOWN) and experienced drug allergy. On 01May2021, the patient had dermatographic urticaria on her torso and neck, the region would be itchy and when she scratched it, it raised into welt like hives where her nails were. These took about 30 minutes to go away. It was reported that the only change in the past 2 months to cause this was getting the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dermatographic urticaria on "my" torso and neck and the region will be itchy and when "I" scratch it, it raises into welt like hives where "my" nails were was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Fluish; Felt yucky; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms and feeling unwell. On an unknown date, the outcome of the influenza-like symptoms and feeling unwell were unknown.   It was unknown if the reporter considered the influenza-like symptoms and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was the patient's daughter. The patient felt fluish for a day or two after getting the vaccine. She felt yucky. The reporter statesd that her mother was private and would not want her information to be shared. The reporter consented to follow up. This case has been linked with case US2019226090, reported by the same reporter.
At around midnight to 1 am, patient reports of developing a fever that would not subside, racing heart rate, extreme fatigue, developed a UTI, stye on eye, and cold sores on 10/24 patient went to the emergency room and was told by ER doctor she was having an adverse reaction to the flu vaccination. Patient was prescribed macrobid to treat the UTI and valtrex for the cold sores