chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed rash all over their body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Developed rash all over their body) in a 43-year-old female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Developed rash all over their body). At the time of the report, RASH (Developed rash all over their body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment details included steroid injection and an steroid pack.    This case was linked to US-MODERNATX, INC.-MOD-2021-012597 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-012597:Cross link (patient 1)
pt recv 16SEP96 & SEP96 pt exp paresthesia in the soles of both feet;noted that motor & sensory were intact;pt also noted that had eaten a lot of fresh apples recently;
shaking; breathing difficulties; rapid heart rate; very ill; This case was reported by a consumer via call center representative and described the occurrence of tremor in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tremor, difficulty breathing, heart rate increased and malaise. Shingrix was discontinued. On an unknown date, the outcome of the tremor, difficulty breathing, heart rate increased and malaise were recovered/resolved.   It was unknown if the reporter considered the tremor, difficulty breathing, heart rate increased and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st Shingrix vaccine and developed shaking, breathing difficulties and rapid heart rate.  The patient was very ill and his symptoms lasted for about 6 to 7 hours. His physician advised that he not get the 2nd Shingrix vaccine. The reporter did not consent to follow up.
A lot of bruising on the arm where the needle was inserted; More bleeding the second time than the first,  there was more difficulty getting the needle in the second time and there was more blood; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (A lot of bruising on the arm where the needle was inserted) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (More bleeding the second time than the first,  there was more difficulty getting the needle in the second time and there was more blood) in a 53-year-old female 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 SITE BRUISING (A lot of bruising on the arm where the needle was inserted) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (More bleeding the second time than the first,  there was more difficulty getting the needle in the second time and there was more blood). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE BRUISING (A lot of bruising on the arm where the needle was inserted) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (More bleeding the second time than the first,  there was more difficulty getting the needle in the second time and there was more blood) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter.
Patient complained of shortness of breath, general weakness, dizziness, chest pain which she specifically described as ?angina.? Patient stated symptoms lasted for about 30 minutes then resolved.   No medications administered in response to event.
10/5 through 10/6 high fever 102°F, chills, aches, sweats - flu-like symptoms. On 10/6 forehead broke out with flat red spots that itched. On 10/7 both hands broke out with some flat red spots that itched and multiple fluid-filled bubbles of varying sizes that were painful and itched, pain and itching seized after about 4 or 5 days, spots disappeared after 7-10 days.
Cardiac arrest without resuscitation.  Unknown cause of cardiac arrest. Awaiting autopsy report.
Injection itself was almost sheared; glass part of the vial was sheared off between that and the hub where you would screw the needle on to; it was just this one vial that was broken...It was not administered to a patient; The initial case was missing the following minimum criteria: Product complaint only. Upon receipt of follow-up information on 15Aug2023, this case now contains all the required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group.  A patient (no qualifiers provided) received pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 20), (Lot number: GT6702, Expiration Date: Oct2024) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "Injection itself was almost sheared; glass part of the vial was sheared off between that and the hub where you would screw the needle on to; it was just this one vial that was broken...It was not administered to a patient".  Additional information: The clinic received an order of PREVNAR 20 and when the reporter was opening the package of medication to put into their hands on bin, she noticed that one of the injections, the injection itself was almost sheared, the glass part of the vial was sheared off between that and the hub where you would screw the needle on to. There was nothing wrong with the package itself, but it was like the glass itself was broken at that time. The nurse stated it was not administered to a patient. It was just taken out of the box. All the packages received were intact, but it was just this one vial that was broken. Product Quality Group provided investigation results. Reportability Determination: This is Medical Device Related. Reportability Determination: This complaint for I noticed that one of the injections, the injection itself was almost sheared, the glass part of the vial was sheared off between that and the hub where you would screw the needle on to. There was nothing wrong with the package itself, but as I said it was like the glass itself was broken at that time. for PREVNAR 20V PFS SUSPENSION 0.5MLX10 is a reportable malfunction. If it were to recur, it could likely cause or contribute to death or serious injury.
The adverse event for the 2nd dose was similar to the 1st. I had abdominal pain, chills, and nausea. I was on vacation. I went to the ER. They said I did not have a fever. They did a urinalysis and blood work. They wanted to do an MRI with dye. I was also given something for nausea and pain. Shortly after the medication, I started having severe chest pains. They then did an EEG. They said my heart was okay and some people DO have reactions like chest pain after pain medications, I have never had a reaction as such before. They did the MRI and said I had a UTI and a viral gastrointestinal infection. I thought that was strange because no one on the trip was sick at all. I was given antibiotics and pain medications. At a follow up appointment, after blood work was done, I was told I am low on Vitamin D which is something I have not experienced yet. I received my flu shot on 9/21/2021.
Significant swelling in axilla; discomfort in axilla; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the right arm on 29Mar2021 at 11:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis. The patient had no allergies to medications, food, or other products. Concomitant medications included methotrexate (MANUFACTURER UNKNOWN) 15 mg weekly, folic acid (MANUFACTURER UNKNOWN) 1 mg daily and ibuprofen (MANUFACTURER UNKNOWN)  from an unknown date and  for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021, the patient experienced significant swelling and discomfort in axilla, it did not seem to be associated with lymph nodes. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the event swelling in axilla and discomfort in axilla was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Fever 102.7, extreme night sweats, body aches, neck pain, arm pain, wrist pain, swollen lymph nodes (neck, clavicle and groin), heart palpitations, injection site swelling and redness (made worse with sun exposure) and dizziness
1 month after my 4the dose I started having extremely sharp pain and numbness in the right side of my face and ,over the next few months the symptoms traveled down the right side of my body. In the spring 1975 my parents noticed browm patches on my arms and legs. They also noticed the size of my right arm and leg were smaller in size and started to be much weaker. I then started testing at Hospital and was in continued ctesting,hospitalizations,are and research over the next 16 years of my life. I then experienced Post Polio after the birth of my 3rd child at age 33. I returned to my neurology and was referred to Neurology. I again endured testing,research and care until age 43. Last June 2021 i had a spontaneous bleed in my right satorius muscle that led to compartment syndrome and resulted in a fasciotomy and months of rehabilitation. This occurred a few months after recieving my 2nd Moderna Vaccine.
This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Aug2021 19:45 (Lot number: FC3180) at the age of 56 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "HTN" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "Known Allergy: PCN" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lyrica, reaction(s): "Known Allergy: Lyrica". The following information was reported: TREMOR (non-serious) with onset 24Aug2021 12:00, outcome "recovering", described as "Inside and outside tremors and shaking feeling like my heart was racing but wasn't"; INSOMNIA (non-serious) with onset 24Aug2021 12:00, outcome "recovering", described as "Enough to keep me awake"; HEADACHE (non-serious) with onset 24Aug2021 12:00, outcome "recovering", described as "Headache"; VISION BLURRED (non-serious) with onset 24Aug2021 12:00, outcome "recovering", described as "blurry vision"; FATIGUE (non-serious) with onset 24Aug2021 12:00, outcome "recovering", described as "fatigue"; PYREXIA (non-serious) with onset 24Aug2021 12:00, outcome "recovered" (28Aug2021), described as "Temp to 100.4 x 4 days"; PALPITATIONS (non-serious) with onset 24Aug2021 12:00, outcome "recovering", described as "My heart was racing"; NERVOUSNESS (non-serious) with onset 24Aug2021 12:00, outcome "recovering", described as "shaking feeling". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tremor, insomnia, headache, vision blurred, fatigue, pyrexia, palpitations, nervousness. Additional information: Patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination nor been tested for COVID-19 since the vaccination. No follow-up attempts are possible. No further information is expected.
On 7/5/00 the pt developed abdominal pain. The pt sought medical attention and was diagnosed with hepatitis A. Confirmatory tests are pending. Additional information is expected.
dog bite on 22JUL96 rt thigh;22JUL96 given vax & 23JUL96 gen achiness, low grade fever, soreness, redness in lt deltoid;
Symptoms signs, time course etc. Shot given 4/9/21. Had sore.
Experienced itching at injection site just a short time after receiving immunization.  Over the course of the next day and a half, she developed a red, warm, raised area, oblong in shape and 2-3 inches in size. She will be calling her physician.
1ST COVID VACCINE GIVEN 03/18/2021 2ND DOSE GIVEN 4/8/2021  GIVEN TOO SOON
Fatigue; Tingly tongue; throat felt itchy; Headache; Nauseous; This spontaneous case was reported by a nurse and describes the occurrence of GLOSSITIS (Tingly tongue), THROAT IRRITATION (throat felt itchy), HEADACHE (Headache), NAUSEA (Nauseous) and FATIGUE (Fatigue) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced GLOSSITIS (Tingly tongue), THROAT IRRITATION (throat felt itchy), HEADACHE (Headache) and NAUSEA (Nauseous). On an unknown date, the patient experienced FATIGUE (Fatigue). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) for Adverse event, at an unspecified dose and frequency; ONDANSETRON (ZOFRAN [ONDANSETRON]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, GLOSSITIS (Tingly tongue), THROAT IRRITATION (throat felt itchy), HEADACHE (Headache), NAUSEA (Nauseous) and FATIGUE (Fatigue) was resolving.        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.   No concomitant medications reported.
Double vision and decreased balance.  The patient had been traveling to another country. Upon return he developed some headaches and stomach upset.  His wife actually came to the emergency room for a similar situation. Prior to admission he started noticing some imbalance.  The next morning he was unable to ambulate on his own.  He does have some base line decrease in his balance, but previously he had not been needing to use an assistive device.  He was admitted to hospital for further evaluation.  Neurology was consulted.  Neurology monitored him, consideration was for treatment for Guillain-Barre, however, due to significant improvement this was not required.  He was started in therapy services.  1/18/08 Reviewed hospital medical records which reveals patient experienced URI w/cough, HA & upset stomach while on foreign travel.  On return, developed difficulty walking & imbalance w/slurred speech, diplopia.  Also has chronic numbness over arms/legs which was unchanged.  Admitted 10/19-10/25/2007.  Neuro consult done.  Patient had spontaneous recovery w/o treatment.  Transferred to inpatient rehab 10-25-11/1/2007.  D/C to home w/continued outpatient PT/OT & f/u w/pcp. FINAL DX: Guillain-Barre syndrome, Miller-Fisher variant w/diplopia & ataxia; HTN. 1/25/08 Reviewed EMG/NCS report of 10/22/07 which concludes generalized sensory/motor polyneuropathy w/axonal & demyelinating feathres.
No adverse event.  The was a COVID-19 vaccine administration error where a 16 year old received the 5-11 Pfizer product.
Patient presented to our facility with new onset diarrhea.  The patient was diagnosed with COVID-19 pneumonia.  The patient was thought to have large volume diarrhea due to this.  The patient was also dehydrated with acute kidney injury and metabolic acidosis.  This ultimately resolved well.  The patient had a mildly leukopenia as can be seen in this viral illness.  The patient did have some mild decrease in oxygen saturations and so she was watched for an additional 24 hours to ensure stability.  The patient had no shortness of breath, but patient did have rales.  The patient was felt to be safe for discharge but did have a home oxygen evaluation and did go home with appropriate oxygen.  As of today (11/8/2021), she is still on oxygen with activity.
Diarrhea, fatigue, glands swollen in neck bilaterally (under jaw) Narrative:
Local reaction on R upper arm (injection site) with erythema, warmth and mild tenderness.  Keflex 500 mg PO BID x 7 days BENADRYL 25 ml after 6 hours PRN.
Severe headache, body aches, fever (possibly even delirium)-which lasted 12 hours. Some slight nausea during the first week as well as lack of energy/tiredness. Extreme pain, heat, redness, swelling at injection site which spread about 2 inches either side and lasted 7 days. I slept a lot during the first 7 days e.g. having to go to bed mid afternoon and sleeping right through till the following morning. Wasn't able to do much gardening and couldn't go to gym classes. After 10 days there is still some redness and swelling and a red circle at injection site about the size of a pencil eraser. Went to gym class and felt slightly nauseous and shivery, lay down in the afternoon and didn't feel well enough to attend an evening event. Slept 12 hours. Today is day 12 and still not feeling great.
During routine monthly inventory in the immunization clinic an expired PPSV23 (pneumovax 23 vaccine) box was discovered.  The box was missing 7 vials.  It is unsure when the vials were used.  They could have been used prior to the expiration date, but that could not be verified.  A report from 9 Jan 2022 to 4 Mar 2022 was pulled and there was 9 doses of PPSV23 given.  The lot numbers as recorded matched a valid, unexpired box.  It is possible that expired doses were given, but it is also possible that no expired doses were given.
Case number PHEH2014US020305 is an initial spontaneous report received from a nurse on 07 OCT 2014. This report refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with FLUVIRIN 2014/2015 (batch number: not reported) intramuscularly which was stored above refrigeration temperature so that the patient experience less sore. No adverse event was reported following the administration error (incorrect storage of drug).
Client received High Dose FluZone vaccine and should have received regular dose. At time of report, client unavailable to discuss if adverse reaction or treatment was received.
We saw when submitting report that this patient have got Pfizer vaccine in January and February 1st and second dose respectively. He got Janssen 1 dose vaccine with us 06/09/21.
In addition to arm pain for two days, I also had chest pains/tightness. I felt the chest tightness the morning after getting the vaccine. The chest tightness continued until 1/23.  It was not a constant pain, but sometimes when I would move a certain way, my chest would hurt. The spot that hurt is right in the middle of my chest. It got worse when I would exercise and breathe heavily. The chest pain continued to stop and come back for several weeks. The night after I received the vaccine, I felt dizzy and felt as if I would pass out, but did not. This only happened one time and was better when I woke up the next morning.   The weekend after I got the vaccine, I was worried I might have covid, so I got tested for covid, but the results came back negative.
PATIENT CAME TO CLINIC WITH HIS NEICE WHO REPORTED HE WAS HERE FOR HIS FIRST COVID VACCINE. NURSE ADMINISTERED VACCINE WITH NO KNOWLEDGE THAT HE ALREADY HAD RECEIEVED PFIZER COVID VACCINE 1ST DOSE ON 03/03/2021 AND PFIZER COVID VACCINE 2ND DOSE ON 03/30/2021
No known adverse event. Reporting because Moderna COVID-19 vaccine was administered to a 17 year old. Please note that the contact information reported is for the 17 year old. Her provider has been contacted and attempts have been made to inform her parents but we are unable to reach them by phone today.
Pfizer vaccine was reconstituted with 1 mL saline and then 0.5cc given, Wrong dilution and wrong dose amount given to the wife of a home care patient in the home. RN was in the home for at least 30 min following the administration tending to her husband's homecare visit. Manager called the client later in the afternoon to report the vaccination error and there were no adverse reactions occurring at that time. Call was made the next day 4/3/21 to the client, reports a sore injection site. Call was made on 4/5/21 for follow up and soreness of the injections site resolved after 24 hours.
Information has been received from a physician, via a company representative, concerning a female patient (age not reported) who on an unknown date was vaccinated with a dose of GARDASIL. Following the vaccination, the patient had redness at the injection site. She was evaluated by healthcare professionals. Subsequently, the patient recovered (duration not specified). This is one of two reports received from the same source (WAES #0710USA00946).
The first indication that something was wrong was when I woke up with fecal matter in my bed. I have colitis so I thought it had something to do with that. Everything I ate ran right through me and sent me straight to the bathroom. During this time, I lost about five pounds. On Thursday night, my bridge partner said a lot of people contracted COVID-19. I tested myself for COVID-19 at home. My symptoms were more gastrointestinal. I never had a fever. My oxygen was always good. I felt very fatigued and had body aches. I called my doctor. My doctor prescribed Paxlovid. I started it the next day and took it for five days. It left a bad taste in mouth. After day three of the Paxlovid, I really started to feel better. I still feel very fatigued and unmotivated to do normal activities.
Got Guillain-Barre; This case was reported by a pharmacist via call center representative and described the occurrence of guillain barre syndrome in a patient who received Flu Seasonal TIV Dresden (Flu trivalent vaccine) for prophylaxis.   On an unknown date, the patient received Flu trivalent vaccine. On an unknown date, unknown after receiving Flu trivalent vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Flu trivalent vaccine.  Additional details were provided as follows: The age at vaccination was not provided. The pharmacist was inquiring about Shingrix, if there was data that it could cause Guillain-Barre as a patient received a flu shot 10 years ago and got Guillain-Barre.