chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash on arm; swelling on arm; Pain / pain on his left arm; This case was reported by a consumer via call center representative and described the occurrence of rash in a 56-year-old 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, between 3 and 4 months after receiving Shingrix, the patient experienced rash, swelling arm and pain in arm. On an unknown date, the outcome of the rash, swelling arm and pain in arm were recovered/resolved.   It was unknown if the reporter considered the rash, swelling arm and pain in arm to be related to Shingrix.  Additional case details were reported as follows: The niece did not have the patient exact age and estimated that he was 56 years old. The patient received vaccine in unknown arm. The reporter did not knew the lot number or expiry date of vaccine. The patient received the initial dose of Shingrix in either May or June of 2019 and developed a rash, a swollen area approximately 2.5 inches wide and 3.5 inches long, and pain on his left arm.   These events resolved after 10 days. The reporter declined to provide an address. The reporter did not give permission to follow up.
Patient was given an expired dose.  Unware that the patient was given an expired dose of covid at the time it was given. Found out later that day that covid vaccine was expired. Someone left the vail and I saw a co worker drawing up the vaccine so I assumed it was from today as well and draw up the vaccine I also told the supervisor about them just drawing one vaccine each time rather then drawing all six. Supervisors told me to draw up the remaining vaccine which were to and give them to patients, so I did. Minutes later we found out that vaccine was expired. Patient was notified about the error and understood. Patient was notified that their no harm to the patient and patient can come back to get another vaccine. Patient accepted the apology.
On day 9 after receiving my first dose, I developed a large (approx. 2 inches long) red rash at the injection site, along with red rash marks from the band-aid.  Some itchiness occurred.
Felt hot and didn?t feel very well  2 hours after shot. The next day around 11:00 am I had a slight headaches  About 5:00 I took my temperature it was 100. 3 my head start hurting worst, started having chills so I went o bed. Woke up at 12:30 am my temperature was 101.1, I called the hospital, no advice was given, they act unconcerned. I took another Tylenol and went back to sleep praying I would wake up. This morning I woke at 8 feeling normal.
After taking the vax the patients blood pressure went from 130/60 up to 170/70.  His heart rate was around 60 and went to 80 and 90.  Patient was having difficulty sleeping.  He was exhausted and fell when trying to walk.  He went to the hospital on 3/8 or 3/9.  He had an X-Ray of his left hand/thumb.  Nothing was broken.  Blood pressure and heart rate is better but still not back to normal.  His seems to be sleeping more now and feels some better.
Fever, body aches, weakness, fatigue , headache, groggy ness  Fever: alleviated with Tylenol
pt recv vax 16MAR94 & 22MAR94 pt devel a rash on face; it was noted that @ the time pt started working w/guinea pig; RAST testing for brewer's yeast & guinea pig epithelium revealed 0;
At time of injection, felt it go straight down my arm (toward my elbow). About two hours later, had headache starting from the bottom back right side of my neck up into the back right side of my head.  In the middle of the night (15 hours after injection), I woke up with chills an quick pulse and had both for about 1 hour. I took 2 TYLENOL at that time. On hour later, I woke up with my clothes wet as when a fever breaks. It is now 22 hours after the injection, and I still have the same headache in the same location described above, plus in general feel achy all over.
Start later that day with chills and fever of 101  temperature went up and down till the next day next day still had chills and temperature about 6 o?clock in the afternoon a headache started temperature was high 100 went to bed woke up around 2 o?clock  and my lymph nodes are swollen left side
This spontaneous report as received from a physician refers to male patients of unknown age. The patients were vaccinated with GARDASIL (Lot #, dose/frequency, route and duration were unspecified) on an unknown date. The physician stated that "when GARDASIL was administered to boys they complained of itching at the injection site when girls had such complaint". It was unspecified whether the patients had sought medical attention or not. The outcome was unknown. Additional information has been requested.
I received my first COVID vaccine 01/18/2021.  I was told it would be MODERNA, and that was entered on my COVID-19 Vaccination Record Card as LOT # 025L20A. I received my second vaccination on 2/15/2021 and my VRC was noted as MODERNA LOT# 006M20A.  My Medical record indicates that I received a PFIZER COVID-19 VACCINE  on 01/18/2021 LOT # EL3246 , NDC:59267-1000-1 and  on 02/15/2021 I received a COVID-19, mRNA, LNP-S, PF (MODERNA)  Lot #:006M20A, NDC:80777-273-10.
Information has been received from a consumer concerning an approx. 1 year old twin pt who in approx. 3/98, was vaccinated with MMRII. It was reported that the child has been dx'd with autism. Three other pts (WAES 01081467; 01082120; 01082832 (twin)) had similar experiences after vaccination with MMRII. The consumer reported that there may be other cases as well. Upon internal review, Autism was considered to be an "Other Important Medical Event". Additional information has been requested.
Case number PHEH2015US021222, is an initial spontaneous report from a health care professional received on 19 Oct 2015. This report refers to a 2 years old male patient. Medical history and concomitant medications were not reported. The patient was inadvertently vaccinated with FLUCELVAX (batch number: 1733991) at a dose of 0.5 ml intramuscularly on 15 Oct 2015. The case was assessed as non-serious. No adverse event was reported.
About 10 hours after receiving the vaccine, I woke up in a cold sweat, with a fever of 103. I had severe stomach cramps, Extreme exhaustion, headaches, muscle pains, and was out for a couple days.  I went to sleep around noon after having all of the stomach issues, and slept until almost noon the following day, excluding getting up to go to the bathroom countless times. Over the course of the next four days, I could not eat anything because it either went right through me or was vomited .  I ended up losing 12 pounds due to not being able to eat from Friday through Thursday.
No side effects until 8th day after shot. Rash and swollen in right arm (injection site) warm to the touch and moving slowly down. Arm is sore and feels tired.
Pregnant and received vaccine; Arm soreness; Body aches; chills; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received vaccine), PAIN IN EXTREMITY (Arm soreness), PAIN (Body aches) and CHILLS (chills) in a 25-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live, full-term birth) on 28-Feb-2016.    On 05-Jan-2021 at 11:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 01-Jul-2021. On 05-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received vaccine), PAIN IN EXTREMITY (Arm soreness) and PAIN (Body aches). 05-Jan-2021, the patient experienced CHILLS (chills). On 05-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received vaccine) had resolved. On 06-Jan-2021, PAIN IN EXTREMITY (Arm soreness), PAIN (Body aches) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
This spontaneous case was reported by a non-health professional and describes the occurrence of Lethargy, Loss of taste, sense of smell has also acutely been effected, myalgia, and chills in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced lethargy, myalgia, chills, and headache. On 11-Apr-2021, the patient experienced loss of taste and sense of smell has also acutely been effected. At the time of the report, lethargy, myalgia, chills, and headache was resolving and loss of taste and sense of smell has also acutely been effected outcome was unknown.            Treatment information was not provided. Concomitant medications were not reported.
After receiving the 1st shot patient fell and hit her head,; hit her head, In total patient has hit her head 9 times due to the falls; very depressed when she got the first shot; This spontaneous case was reported by a patient and describes the occurrence of FALL (After receiving the 1st shot patient fell and hit her head,), HEAD INJURY (hit her head, In total patient has hit her head 9 times due to the falls) and DEPRESSION (very depressed when she got the first shot) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03821A) for COVID-19 vaccination.     The patient's past medical history included Myelofibrosis in 1989, COVID-19 (in 202 when the pandemic started she got COVID and had to stay at home) and Immunocompromised. Concurrent medical conditions included Hypertension and Allergy NOS (Some allergies). Concomitant products included VITAMINS NOS for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FALL (After receiving the 1st shot patient fell and hit her head,), HEAD INJURY (hit her head, In total patient has hit her head 9 times due to the falls) and DEPRESSION (very depressed when she got the first shot). At the time of the report, FALL (After receiving the 1st shot patient fell and hit her head,), HEAD INJURY (hit her head, In total patient has hit her head 9 times due to the falls) and DEPRESSION (very depressed when she got the first shot) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concurrent medications included medications for high blood pressure. Treatment details was not reported by the reporter.   This case was linked to MOD-2022-572048 (Patient Link).
Pt recvd 3 doses of vax on 14DEC91, 14JAN92, &  12JUN92 & on exp inc serum bilirubin; lab eval revealed total serum bilirubin 2.8 mg/dL, direct serum bilirubin 0.7, indirect serum bilirubin 2.1; repeat tests showed total serum bilirubin 3.5
Really stiff neck from ear down to collar bone; Slight fever; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), MUSCULOSKELETAL STIFFNESS (Really stiff neck from ear down to collar bone) and PYREXIA (Slight fever) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PAIN (Body aches) and PYREXIA (Slight fever). On 12-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Really stiff neck from ear down to collar bone). At the time of the report, PAIN (Body aches), MUSCULOSKELETAL STIFFNESS (Really stiff neck from ear down to collar bone) and PYREXIA (Slight fever) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable  Concomitant medication includes allergy medicine.  Treatment medication was not provided.
This spontaneous reprot was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No concurrent conditions or medical history was reported. On an unknown date the patients were vaccinated with VARIVAX (Merck) (lot # L00456, dose and route of administration not provided) that may have been improperly stored for the month of June 2015. No adverse symptoms was reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the two reports from same reporter link (1507USA004343). Additional information has been requested.
Patient explained that within just hours of the vaccination administration she noticed the darkening of one of her toes. It continued to the color black and is continuing to move up the foot toward the ankle.
The infant had an immediate reaction at the MMR injection site. With moderate erythema, warmth, in duration patient was stable and activity unchanged. 4ml given of Motrin and Benadryl. Recommended to continue Benadryl / Motrin Q HS X 3 nights.
Tested positive for COVID on 08/2/2021 had an exposure at work and is having some mild symptoms.
Initial report received from literature on 29 Oct 2014. The following is the verbatim for the article abstract: We present the case of a 19-year-old who developed psychotic symptoms after exposure to a potentially rabid animal and post-exposure prophylactic treatment. This case serves to remind physicians to fully explore the possibility of a nonpsychiatric origin of de novo psychotic symptoms and provides indirect evidence in favor of the possible involvement of the immune system in the development of psychotic disorders. A 19-year-old female patient had received a first dose RABIES VACCINE (manufacturer- unknown, batch number, route and anatomical site of administration was not reported) on an unspecified date and second dose RABIES VACCINE (manufacturer- unknown, batch number, route and anatomical site of administration was not reported) on an unspecified date. The patient had no other significant medical history and her parents denied any personal or family history of psychiatric illness, suicide or substance use. On an unspecified date after two days following her second shot patient developed difficulties sleeping, reported hearing multiple voices, after four days later of second shot patient's sister called her stating that the patient was anxiously packing up her belongings and repeating "there are demons in the house, I can't stay", patient appeared malnourished and reported no desire to eat or drink and partially healed bite wound on her left calf, psychosis not otherwise specified, Psychosis secondary to general medical condition, such as rabies or rabies vaccine and post-vaccine encephalopathy. It was reported that on patient appeared extremely anxious and confused with simple tasks such as inserting braces for her teeth or putting on eye-glasses and patient memory, attention and concentration were poor, as were insight and judgment, impulse control was intact. On physical examination, patient was spiking a fever of 100.6-100.8 F (38.1-38.2 degree C). On an unspecified date patient was hospitalized. Patient had received a haloperidol 2 mg by mouth mornings and evenings, lorazepam 1 mg by mouth twice/day, and olanzapine 5 mg by mouth evenings, Amoxicillin 875 mg/clavulanate potassium 125 mg by mouth every 12 hours was added to counter any bacterial infection at the origin of the fever and discharged after two weeks patient received olanzapine 5 mg by mouth twice/day and clonazepam 0.5 mg by mouth evenings and quetiapine 100 mg twice/day as a corrective treatment. Laboratory investigations included on an unspecified date Complete blood count, comprehensive metabolic panel, urine toxicology, EKG (Electrocardiogram), urine analysis, urine pregnancy and head CT (computed tomography) scan were all within normal limits. On an unspecified date lab investigations showed increased liver enzymes from the previous PER visit ALT 58-670 U/L, (alanine aminotransferase), AST 114-255U/L (aspartate aminotransferase). At the time of this report, patient outcome was recovered on an unspecified date; however patient was discharged from the hospital on an unknown date. List of documents held by sender: none.
Continuing to feel sensitive to light, itchy and sore; Eyes began to get sore; Eyes began to get sore, dry; eyes began to get sore, dry and sensitive to light; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administration in the left arm on 06May2021 at 09:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food or other products. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) via an unspecified route of administration in the left arm on 15Apr2021 at 09:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that first dose had no side effects, not even soreness in the arm. On 06May2021 at 11:30, after 2 hours of vaccination, the patient's eyes began to get sore, dry and sensitive to light. On 07May2021 at 10:30, after 25 hours of vaccination, the patient's eyes were continuing to feel sensitive to light, itchy and sore. They were not swollen however it hurt to keep them open. The patient did not wear makeup or used any products on her face. Therapeutic measures were not taken as a result of these events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events eyes began to get sore, dry, sensitive to light and itchy eye was not resolved at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Patient said he was itching on his arms, lower back, and legs.  Patient had mild redness on his lower back. Patient went to the emergency room.  They did not diagnose him with anything, no labs were done, no medications prescribed, no recommendations were made, and patient was release.  Patient came to the pharmacy after his ER visit and said he feels good now.
Vaccination #1:  headache, nausea, severe pain in arm, fatigue, body/muscle aches, flutter in chest (created shortness of breath), diarrhea.  These symptoms began approximated 20-30 minutes after injection and lasted for four days. Vaccination #2:  pain in arm, headache and severe flutter in chest (causing shortness of breath) began about two hours after injection.  When I laid down in bed, the /flutter/shortness of breath got worse.  Body/muscle aches, fatigue, and diarrhea began in the morning after injection and lasted for days.  Then the pains in the chest began and the shortness of breath/flutter in chest continued and did not subside until 9/17/2021.  I developed insomnia and low libido  since receiving second vaccination.. My first good night of rest was 9/26/20.  Still experiencing low libido from vaccination
3 days after the shot he started getting flu-like symptoms.  This included headache, diarrhea, tiredness, weakness, severe muscle aches, loss of appetite.  Contacted his cancer dr. and was told to stop the Calquence for 3 days, drink 8 - 8oz of water a day (which he could not do and threw up after drinking), and to start taking Immodium, which he did.
I start to have allergic rashes on random places on my body. I need to take benedryl to stop the itchiness for the past 2 days and ongoing. It appears off and on.
Hard, itchy, red, welt-like rash that is painful to the touch.  It seems to have increased in size since I first noticed it when I woke up in the morning. There are some raised marks within the rash.  The rash is around the injection site.
Initial information received on 13-Dec-2018 regarding an unsolicited valid non-serious case received from a other health care professional. This case involves six-years-old patient (gender not reported) who was vaccinated with 0.5 ml dose of FLUBLOK QIV (Batch number: QFAA1832, expiration date: 30 Jun 2019, dose, route and site of administration was not reported) on 13 Dec 2018 (reported as today). The patients' medical history and concomitant medications were not reported. No other vaccines were given at this visit. It was an actual medication error due to inappropriate age at vaccine administration. It was reported that there haven't been any side effects reported so far. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Miscarriage on 13May2021/seriousness criterion was reported as 'Congenital anomaly/birth defect'; Miscarriage on 13May2021/seriousness criterion was reported as 'Congenital anomaly/birth defect'; This is a spontaneous report from a contactable consumer (patient). This is the baby case.   A 34-year-old female patient received the 1st single dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, in left arm on 18Apr2021 (Batch/Lot Number: Ew161), and the 2nd single dose, always in the left arm, on 02May2021 (Batch/Lot Number: Ew0171), for COVID-19 immunisation. First and second dose were administered at the age of 34 years old. Relevant medical history was reported as none. The patient's last menstrual period was on 18Feb2021 and pregnancy due date was 26Dec2021. Concomitant medications included unspecified pre-natal vitamins. Relevant past drug history included sulfa. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was never diagnosed with COVID-19, and since the vaccination the patient had not been tested for COVID-19. The patient reported having miscarriage on 13May2021, diagnosed after the 2nd shot of BNT162b2. A doctor or other healthcare professional office/clinic visit was needed. The fetus had died sometime between the 1st and 2nd shot based on gestational age. Gestation period when the event was observed was reported as 4 weeks. The patient had to undergo dilation and curettage from which the patient was recovering. The seriousness criterion was reported as 'Congenital anomaly/birth defect' (no further information reported about the congenital anomaly).  No follow up attempts are needed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021602163 mother/baby case; Reported Cause(s) of Death: Miscarriage; Congenital anomaly; Miscarriage; Congenital anomaly