chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received vaccines at 15 month appointment on 4/12/21.  Mother reported on 4/13/21 area on right thigh had slight redness and swelling.  On 4/14/21, mother reached out to office as redness had spread to majority of thigh, area was warm to touch, swollen and hard to touch.  Patient seen in office, assessed by provider and out of abundance of caution, patient was placed on 7 days of cephalexin for possible cellulitis.  Office followed up with mother on 4/15/21 via phone and mother reported that redness was improved, but she still had swelling and firmness to the area.  Mother reports that they will continue to monitor and if area worsens or patient worsens, she will contact office.
Rash on back noticed last night started and looked like a bug bite then spread down leg has been scratching but states that it hurts, no fever, cough and cold sx off and on all the time, slept ok last night, eating well and still playful, no recent changes.
12:28pm Splotchy red rash  on L deltoid ( shot site) and  chest  traveling up left neck  and  ear. Patient given  Diphenhydramine 25 mg  PO.    BP:135/84 p:81  Monitored vital signs: 12:35: 125/86 p:83 12:40: 119/83 p:76 12:46: 133/91 p: 92 Rash  fading 12:50: 125/80 p:92 Rash much more diminished and patient denies any shortness of breath, scratchy throat, itchy ness or other symptoms.  Ate a granola bar and them dismissed with instructions to call 911 if  scratchy throat or difficulty breathing occur.
Patient was seen for chronic cough on 3/1/2019. She also received dose #2 of SHINGRIX at that visit, IM in L arm. She reports with 1st dose she had some fatigue and arm pain. She received the dose #2 around 9 am on 3/1/2019. She reports around 5 pm on 3/1/2019, she developed chills, body aches, fatigue, malaise, and generalized weakness. Her symptoms were severe enough that she had to call off work. Today, 3/4/2019, she reports her symptoms are improving but not resolved.
Information has been received from a physician concerning a 20 year old female with a history of human papillomavirus high risk. On 11-FEB-2009, the patient came in the office because she had an upper respiratory infection and was given ALERXPE (manufacturer unspecified) and Azithromycin manufacturer unspecified). On 19-FEB-2009, the patient came into the office and received her first dose of GARDASIL (lot # 661044/0548X) (dose not report). The mother then called the office and said after receiving GARDASIL the patient experienced night sweats and her period was eleven days late. The mother of the patient mentioned that she was unsure if the patient should receive the second dose of GARDAIL. On unspecified date, the patient sought unspecified medical attention. On an unknown date, the physician reported that the patient had recovered but there were still unsure if she could receive the second dose of GARDASIL. Additional information has been requested.
Random dizziness, headache and left arm injection site  slight swelling.    Now under arm area/ armpit is slightly swollen and very tender.  Started taking ibuprofen for inflammation and headache
Patient developed symptoms of numbness, tingling and shortness of breath within 5-10 minutes of her 2nd Moderna vaccine.  She had numbness and tingling with first dose but short-lived and more mild.  These can be part of allergic reaction to the vaccine.  She subsequently developed months of lymphadenopathy, fatigue, myalgias and flaring of her chronic disease processes that suggest significant stimulation to her immune system.
How long are the side effects; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-May-2021 and was forwarded to Moderna on 27-May-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (How long are the side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (How long are the side effects). At the time of the report, VACCINATION COMPLICATION (How long are the side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.   Reporter did not allow further contact
Exactly 2 weeks after receiving the PREVNAR 13 vaccine I started with symptoms of tingling in my hands and feet which within days became acute Guillain Barre syndrome. I spent almost 1 week in the Neurology Ward of Hospital receiving IVIG treatment and then almost 2 weeks in the Rehab Hospital receiving PT, OT and SLP therapy.
Swelling of face, redness, excess sweating and overheating, allergy-type reaction, skin blotches compared to snake skin, eczema like reaction with no history of skin disorders. Painful to the touch
large red spot developed on left arm at injection site  - was a small spot at bandaid location first night but increased in size redness and hotness on 4/6 and 4/7 - to about 4in by 2in, size of my hand.  Hot to the touch.  Also fever and chills on 4/6 (temp 100.8). very tired on 4/6 and still a bit tired on 4/7.  Red spot still hot and large on 4/9.  Took advil late on 4/5 and morning of 4/6.  took tylenol evening of 4/6.  slept a lot on 4/6.
About 2 hrs after flu shot, she became itchy from head to toe, had an asthma attack and her throat started to swell and close. Pt gave herself her anaphylactic meds at home and was fine.
Patient reports around 11 pm 12/20/2021 began having flu like symptoms, still lingering today, 1/21/20221. Injection site pain, joint pain, muscle pain, drowsiness.
Immunization (3rd in series) 11:15 am at 1240 approximately 1 1/2 hr later reports dizziness 120/60 78 20 Sat 98 temp 77.9. Approx 1250 ml water po 100/60 80 20, 100/60 71 20 Sat 98%, dizziness resolved.  100/60 86 20 97% 100/70 76 20 Sat 90%
Fatigue- started around two hours after injection Diarrhea- sudden onset (type 7 on the Bristol Stool Chart)- around 5.5 hours after injection.
Starting on the 4th day, itchy in the injection site and pale small light pinkish area was noted; light swelling also behind the injection site. On the 7th day, very very itchy and Benedryl cream helped; Redness area got bigger and color intensity increased. Today is the 8th day and still itching and red.
Swollen lymph gland in left side of neck.  small in size , but very tender.  Seen at Urgent Care on 1/12/22.  Had full labs done and returned home.   Later that afternoon, began getting very itchy under arm pits which than continued through my entire upper torso, upon looking at body, I was covered in large hives and red inflamed skin.  As the evening progressed the hives spread all the way to my feet. I applied topical Benadryl and took 10mg of Zyrtec.  Over the course of the evening the hives and redness faded by the following morning. The next day I was having chest discomfort throughout the day.  I stayed at home and monitored severity of pain.  This lasted several hours and then diminished by afternoon.
PT CAME IN FOR 2ND DOSE ON 9/20/21. DURING SCREENIGN QUESTIONS, PATIENT STATED HE HAD INCREASE IN HEART RATE AND HEART RATE WAS CONTINOUSLY FAST POST VACCINATION.
hives; This case was reported by a consumer via interactive digital media and described the occurrence of hives in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included umeclidinium bromide, vilanterol trifenatate (Anoro).   On 7th July 2020, the patient received Shingrix. On 7th July 2020, less than a day after receiving Shingrix and Anoro and less than a day after starting Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient just got the first dose and had hives relieved by H2 blockers.  The patient wanted to know should he or she get the second dose in 3 months. The reporter consented to follow up.
MD was vaxed w/flu vax in OCT93; pt devel severe influenza in DEC93 which lasted for 1 month;
Initial information received on 14-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a four months old female patient who just received the diluent of the PENTACEL (lot C5466AB, C5324AC and Exp. Date 05-Sep-2019) as a first dose via intramuscular route in the left thigh, on 08-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE, PREVNAR 13 and ROTAVIRUS VACCINE for Immunisation. It was an actual medication error case due to inappropriate reconstitution technique. It was unknown whether the patient had any adverse reactions. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
Approximately 10 mins after administration became tachycardic, complained of feeling flushed with tingling feeling; increased BP reading.
This was second shingles shot, 10 wks after first shot. No reactions to first shot. Second shot, woke up at 5am with headache, by 9am nauseated stomach, and arms and legs aching, fever of 100.5.  Took 2 TYLENOL and fever broke about 2pm. Aching and nausea stopped about 6pm. Headache lasted till next morning. Nothing after that.
Per her husband Dr. she developed polymyalgia rheumatica with a sed rate of 100, 2 months ago.
The morning after vaccination,  sore arm,  fatigue,  and  weakness, mainly of the legs.  The symptoms lasted four days.
Bud Date 4/07/2022 administered dose on 4/10/2022 Pfizer could not verify stability and Pfizer advised to readminister vaccine. Readministered Booster 05/04/2022
This case was reported by a physician via sales rep and described the occurrence of pain in arm in a male patient who received 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 pain in arm and general body pain. On an unknown date, the outcome of the pain in arm and general body pain were unknown. It was unknown if the reporter considered the pain in arm and general body pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced side effects described as, sore arm, general aches and pains after receiving SHINGRIX.
Progressively felt worse days after vaccination. Day 4 was the worst, with chills and aches all over body. I also felt like the vaccine effected me emotionally. I felt very depressed after both shots, and usually am not prone to feeling that way. I haven't seen anything that states it has emotional side effects, but 100% believe this vaccine effected my mental health. Symptoms seemed to get better about 2 weeks after each shot.
on the morning of 6-6 patient awoke and noticed swelling of his lips, tightness in his throat, and difficulty swallowing
Injection site became itchy, inflamed, rash, about 2" in diameter. Resolved on it's own after 48 hours.
Patient said that after the shot redness and puffiness occurred. He said the puffiness was pretty severe. Today he said it is much better and just a little puffy and a little pain at injection site.
Adverse Reaction: While at the vaccine clinic felt like eyes were puffy however they didn't appear puffy. About 4hrs after vaccination red hot raised rash appeared on the face by next morning the rash spread and was marbly on the back of arms. On the 10th bad migraine occurred had to take off the 11th.  Severity flucuated to regular headache an back to a migraine level at worst scalp hurt to touch, pressure under scalp.  Saw an allergist 2 days after symptoms started. Patient reports history of migraines, but never this intense, she got ear piercings in 2017 that relieved migraines.
This case was reported by a healthcare professional and described the occurrence of death-unknown cause in a 89-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included atrial fibrillation, cva and dementia. Concurrent medications included ATIVAN, PROZAC, LORTAB, PRILOSEC and CARAFATE. On 3 October 2008 at 17:15 the subject received a dose of FLULAVAL at 0.5 ml in the right arm. On 4 October 2008, approximately 21 hours after vaccination with FLULAVAL, the subject felt cool and clammy, had increased pulse and low blood pressure. Within 5 minutes, the subject experienced death-unknown cause. She was DNR (do not resuscitate). The healthcare professional considered the events were life threatening. The subject died on 4 October 2008, cause of death was not reported. It was unknown whether an autopsy was performed. 1/6/09-records received-Cause of Death-Sudden Cardiac Death. Cerebrovascular Disease. No autopsy performed.
outbreak of Shingles; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix. In July 2020, between 6 and 8 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. All patient identifiers were reported. No details on Batch Number or Expiration date since it was administered on a different facility and they do not have those details. The patient received Shingrix. The patient experienced an outbreak of Shingles. The patient was wondering on how to proceed with 2nd dose. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020123388:same reporter
Chills and body aches starting early morning 02/22/2021.  Developed a fever and this continued throughout the day 02/22/2021. Took some ibuprofen, felt better on 02/23/2021 during the day, then started to develop the same symptoms again plus a severe rash all over my upper body and face.  Went to Urgent Care on 02/24/2021 and the doctor prescribed me with prednisone for a couple of days until my rash subsided. Have not had any symptoms since then. Have been off prednisone for 3 days.
I AWOKE THE NEXT MORNING 10/19 WITH A HEADACHE, SORE THROAT, BODYACHES & CHILLS, EAR ACHE, MALAISE, NO APPETITE AND WENT TO BE BY 7PMOVERNIGHT URINATED AT LEAST 15 TIMES, BODY PAIN WORSENED,  TACTILE TEMP WITH CHILLS AND SWEATS. ON THE MORNING OF 10/20 SYMPTOMS WORSENED, SEVERE BODY ACHES COUGH, NASAL CONGESTION, MIGRAINE HEADACHE, AND VOMITED 3X AT APPROXIMATE 7:30 PM.  I REMAINED IN BED FEELING VERY ILL ALL DAY ON 10/21 AND 10/22.  I CALLED MY PCP DR FOR A PHONE VISIT.  NOT YET WELL, BUT RETURNED TO WORK ON 10/23. CONTINUED WITH FLU LIKE SYMPTOMS, INSOMNIA, BODY ACHES, SINUS HEADACHE.  STILL FEELING POORLY ON 10/24 WITH TEMP OF 99.2, SORE THROAT, EAR PAIN, NASAL CONGESTION, COUGH, MILD HEADACHE, BODY ACHES.  SOMEWHAT IMPROVED BUT I AM STILL WEAK .
POTENTIAL ADMINISTRATION ISSUE OF AN EXPIRED PUNCTURED JANSSEN COVID-19 VACCINE; This spontaneous report received from a pharmacist concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. No concomitant medications were reported. On an unspecified date, the patient experienced potential administration issue of an expired punctured janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of potential administration issue of an expired punctured janssen covid-19 vaccine was not reported. This report was non-serious.
Fever; Headache; Muscle and joint pain; Joint pain; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 01Apr2021 at 11:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS) and COVID-19. Concomitant medications included metformin (MANUFACTURER UNKNOWN) for unknown indication and from an unknown date. The patient previously received sulfonamide (MANUFACTURER UNKNOWN) drugs, and penicillin (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Mar2021 at 10:45 (at the age of 44-years-old) as a single dose for COVID-19 immunisation.  Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 01Apr2021 at 19:00, the patient experienced fever, headache, fatigue, muscle and joint pain. The adverse event did not result in doctor or other healthcare professional office/clinic or emergency room visit. The patient did not receive any treatment for the events. The clinical outcome of the events fever, headache, fatigue, muscle and joint pain were recovered on an unknown date.   No follow-up attempts are needed. No further information is expected.
flu like symptoms; sweaty; clammy; vomiting; bodyaches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERHIDROSIS (sweaty), COLD SWEAT (clammy), VOMITING (vomiting) and MYALGIA (bodyaches) in an 86-year-old female patient 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-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERHIDROSIS (sweaty), COLD SWEAT (clammy), VOMITING (vomiting), MYALGIA (bodyaches) and FATIGUE (fatigue). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERHIDROSIS (sweaty), COLD SWEAT (clammy), VOMITING (vomiting), MYALGIA (bodyaches) and FATIGUE (fatigue) outcome was unknown. Not Provided          No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-215671 (Patient Link).
9/15 could not feel legs.   Unable to walk.   Remittent back spasms.  Went to ER and was admitted for two days.
Pain at site of injection and discomfort left arm with movement. Client saw primary MD and had x-ray left upper arm with neg. results.
11/02/07 - Severe pain Lt arm, shoulder and now down back.  Warm arm.  Got pain med at ER.  Referral to ortho MD who took X-Ray.  Dx - unable to read.  To have ultra sound.
Loss of Appetite; Fever - Temperature of 101.0F; Chills; Headache; Fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of Appetite), PYREXIA (Fever - Temperature of 101.0F), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DECREASED APPETITE (Loss of Appetite), PYREXIA (Fever - Temperature of 101.0F), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, DECREASED APPETITE (Loss of Appetite), PYREXIA (Fever - Temperature of 101.0F), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, Body temperature: 101.0 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Adminstered second dose of vaccine on day 20; A spontaneous report were received from a healthcare professional, concerning a patient of unknown age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) and administered second dose of vaccine on day 20.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 Jan 2021, nurse administered first dose of vaccine to the patient and on 17 Feb 2021 the second dose was administered.  Nurse administered second vaccine to patient on day 20 after 1st Moderna vaccination (Inappropriate schedule of vaccine administered).  Action taken in response to the Inappropriate schedule of vaccine administered was unknown.  The outcome of the event Inappropriate schedule of vaccine administered was unknown.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Inappropriate schedule of vaccine administered without any associated adverse events.; Sender's Comments: 03 Mar 2021: Off label use check box was tick, (as per decription provided in the event section of source document).
Swelling & erythema on (R) leg at administration site of DTaP. BENADRYL & ibuprofen prn.
First felt with whole body with burning sensation,severe urge to urinate.Went to bathroom ,lost control with bowel&bladder.While urinating hands $ whole scalp was itching.Then noticed with mottled skin on bilateral thighs & face & eyes were very red.Felt very weak.Somehow came out of bathroom,Could not even walk,called for help.Felt like passout,Short of breath.As per viewers ,I became very pale white grayish in color.I felt like I am dying .BP 90/50.Blood glucose 102,Oxygenation was 60-70%.Given O2 & taken me to ER.During this time I was cant even talk/stand.ER did all labs,EKG, By 6 PM On & Off becoming pale & body is cold.by 7.30 pm got Benadryl 25mg IV.Then slept for 15 mts,woke up ,felt very good.Then given me Inj Solumedrol 125 mg IV.By 830 got discharged.walked to parking lot.Discharged with Prednisone 60 mg x3 days & Benadryl 25 mg TID x 3 days.I was very weak for a week.Now I feel Okay.