chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Per patient report:  "On Saturday I had the common not feeling good, fever-ish feeling, dizzy, nauseous, vomiting, very tired so I slept it off as much as I could.  Sunday- felt somewhat better minus being dizzy, then started to have a type of swelling in my armpit that was hurting pretty bad, I was hoping it would go away as the day progressed but it did not unfortunately and started to hurt even more in the night   On Monday-when I woke up I was sweaty, and in more pain this time it was in my chest, back and left arm (where I got my covid booster) the lump in my armpit was more tender and was hurting even more (started to scare me since I have had a blood clot in my arm years ago) very nauseous, light headed, felt like I was burning up but was not running a fever, was heavily breathing just walking from one place to the other, I  tried to come to work but as soon as I sat down I decided to check into the ER with the advisement from a coworker who stated I didn't look or sound good at all. After I checked in they did an xray and did labs, they determined my lymph nodes were having a reaction to the vaccine but did not prescribe pain meds (not sure if they would or not but since I am in recovery I wasn't going to take it either way)  but told me to take OTC Tylenol and ibuprophen every 3 hours to help with pain and diagnosed me with an adverse reaction to the covid shot."
4:30 pm (2 hours post vaccination) Redness covering left thigh.  Small bumps around injection site
Lost use of legs and hands.  Went to ER at3:00 AM  11/7/14.  Verified GBS on 11/8 via spinal tap. Remained in Intensive Care Unit for 4 weeks - had 20 treatments of Plasmapheresis; from there went to rehab.
An area of 3 x 4 cm which is raised & red, no warmth or tenderness, itches (L).
noticed a small case of Petechiae on the inside of her upper left arm; This is a spontaneous report from a contactable consumer, the parent. A 16-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 15:00 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Medical history included mild blood disorder, a family history/genetic disposition. Patient had no known allergies. Concomitant medications included nasal spray (MANAFACTURER UNKNOWN) from an unknown date for allergies. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Mar2021 at 15:00 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not 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 vaccination. On 10Apr2021 at 11:00, the patient experienced small case of petechiae on the inside of upper left arm. It was reported that patient's mother had cases of petechiae in the past due to her ITP which had a chronic case prior to having two children. After each pregnancy her platelet count improved and she no longer had ITP since her count was within range on the low end. She was watching news carefully regarding side effects and heard about potential bruising. She told her immediate and extended family to be aware of this, since they had a genetic disposition towards bruising. Two of parent's nieces one who received Moderna vaccine and other who received J and J both had bruising in legs and feet. Told them to report their adverse events to the CDC. All 3 of these adverse events were very mild cases. She stated to have pictures to share of patient's case. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event petechiae on the inside of upper left arm was recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning a patient who "a month or so ago" (in approximately October 2010), was vaccinated with a dose of GARDASIL (route and expire date not reported) (route not reported). The patient fainted shortly after receiving GARDASIL (in approximately October 2010). The patient was wheel chaired out of the office. Patient received a dose of meningococcal vaccine, a dose of Tdap and a dose of GARDASIL one right after the next. The patient was in the office when fainted. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Mom denies that pt had temp; only c/o abnormal high pitched cry from about 6PM until 10PM; given Panadol; Called MD & ER; Pt was fine when held but cried when put down;
Patient's son presented to the pharmacy on 12/1/18 to notify us that patient had experienced extreme pain in same arm as vaccination site after receiving vaccine on 11/29/18. Patient was taken to hospital that day with a pain score between 8-10. After staying in hospital, returned home on 12/1/18 while still in extreme pain. Per patient's son, concerned that his father received a bad batch of the SHINGRIX vaccine.
Redness, sore at injection site - Benadryl cold packs and heat to area, Keflex 500mg #40 GID also had itching at site.
pt recv vax 11FEB97 & pt preg & pt LMP 10MAY96 pt devel redness & swelling around the site of inj;pt gave birth on 15FEB97 to a male w/no abnormalities;child underwent surgery for a testicular hydrocele which was unilateral (WAES97080244);
Within minutes of getting the vaccine I developed itching at the injection site on left arm ...the itching went to my right arm...then developed numbness to left elbow that went down to my fingers on left hand...had chest pressure and a pain that shot up to right side of my head.......had an overwhelming feeling that something wasn't right.  I could taste the medicine /vaccine at the back of my throat, and I started to develop itching to back of throat and was clearing my throat and starting to cough....no difficulty breathing, but my voice was getting hoarse Pharmacist was watching me closely and kept me about 45 minutes.......I was given water and that helped a little and I was able to swallow at that time Symptoms didn't seem to get worse at the store so I was able to leave, but when I was driving home, I developed numbness around my mouth, my cheeks, and into my throat and down into my chest.... felt like my muscles were paralyzed and I could not swallow....my tongue felt thick and heavy, and my throat was tight by the time I got home.... I took more Benadryl as we were getting ready to call EMS....the symptoms gradually subsided and the numbness to chin and throat stayed through the next day
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; product storage error; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and PRODUCT STORAGE ERROR (product storage error).    No concomitant medications were reported.  The case was reported for 10th out of 77 adult patients who had received the vaccine as reported by the reporter.  It was reported that the vaccine was administered to 77 patients before it was known if the vaccine was ok to use after the excursion.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Red, swelling. 12/24  egg sized lump at injection site, pain, hot, itchy for 3 days.  Swelling subsided, but raised, red, itchy rash 4 inches around appeared on 12/28, lasted until 1/4, pink and bruised now.
My Uncle did not have the COVID vaccination.  He was hospitalized for his fistula (infection) and then went into a nursing home for rehab.  Within a week there - he got COVID (mid-January).  He recovered.  From there, he was told he could not go home and needed an Assisted Living.  In order to get placed, he was required to be vaccinated.  In order to get him in somewhere quickly, we were told we should get him the J&J - one shot.  That was done March 16 and he then went into his new facility.  My Uncle started to get noticeable swelling in his right leg in April.  Physical therapy asked that we get him a lift chair that had a reclining feature.  We did that, and it was delivered April 23.  By that time, his leg looked swollen from his hip all the way down.   We waited to see if swelling would go down with reclining.  Wednesday, April 27th we got a call that the facility was sending him to the ER by ambulance.  He was hospitalized through May 4th...and now moved to a rehab facility to recover.
I never had COVID 19. Tested 5x negative. Experiencing pots symptoms ambulanced to hospital now wearing a heart monitor. Pulse goes to 135 used to only be in 50s. I experienced symptoms after first shot that went away and is now back
autoimmune disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "autoimmune disease". Clinical details: the young lady stated that she received Pfizer vaccine and subsequently developed autoimmune disease.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Softball size, raised, red area with warmth around the injection site.  (Right Deltoid) Started on Keflex 500mg TID X 7 days  and ice packs to area until redness resolved Reaction on 12/27/20 Resolved on 1/3/2020
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 08-APR-2016, the patient was vaccinated with an improperly stored dose VARIVAX injection, lot # L044524, expiration date 09-NOV-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 9.9 degrees Fahrenheit for 163 hours and 30 minutes. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
No adverse event as of yet Janssen vaccine administered as second dose instead of Pfizer and given on day 7 instead of day 21
Initially developed mild injection site soreness. Two and a half days later, developed abdominal cramping, bloating, severe diarrhea, muscle aches (especially legs and back), headache, rigors, fevers (high was 103 oral), decreased sats to 91% (normally 98 to 99). Profound weakness. Was in bed for 2.5 days. Took 4 days to recover fully.
Chest feels like there is pressure Unable to sleep due to body pain Nerve pain throughout body Extreme pain in whole left arm Weakness  Flushed skin
Redness and swelling noted to upper L arm. Complained of pain and hot to touch. Advised to apply ic to area and give Tylenol prn.
Patient gotten sick every year from the flu shot; Initial information was received on 23-Jan-2021 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional (Patient).  This case involves patient [age and gender unspecified] who gotten sick every year from the flu shot (illness), while patient received INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  Medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient gotten sick every year from the flu shot (illness) (non-serious) unknown latency following the administration of INFLUENZA VACCINE.  It was reported that, patient have not taken it in years and haven't been sick like that since.  Details of laboratory data not reported (It is unknown if there were lab data/results available).  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
dizziness nausea and vomit Pounding Heachache crushing pain in my left leg numbness on my left side numbness on my face limping leaning to the left side when walking tingling on my gums and teeth
PATIENT CALLED TO STATE THAT HE WAS NOT FEELING WELL AND THAT THE "ROOM WAS SPINNING"
This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored PNEUMOVAX23, lot # L003227, expiry date 13-OCT-2016, (dose, frequency and route of administration were not reported). No adverse effect reported. No product quality complaint (PQC) was involved. This is one of four reports received from the same reporter. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of headache aggravated in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included headache. Concurrent medical conditions included migraine. Concomitant products included AIMOVIG and Calcium Channel Blocker. On 2nd April 2019, the patient received the 1st dose of SHINGRIX. On 3rd April 2019, 1 days after receiving SHINGRIX, the patient experienced headache aggravated. On an unknown date, the outcome of the headache aggravated was not recovered/not resolved. It was unknown if the reporter considered the headache aggravated to be related to SHINGRIX. Additional case details were provided as follows: This case was reported by the patient's boyfriend. The patient had a history of headaches which being in a warmer climate, the headaches had gone away. The patient received the dose of SHINGRIX vaccine and next day, the patient had minor headache and a couple days after the first headache, the patient had another one. Last night of day before reporting, the patient had the worst headache she has had in years. The reporter stated that the patient was also decreasing some of her migraine medications. So, the reporter was not sure the headaches are related to the SHINGRIX vaccine. The reporter did not want to provide any additional details regarding the patient as well as address details. The reporter did not give the consent for follow up.
This case was reported by a physician and described the occurrence of Guillain Barre Syndrome in a 41-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline) for prophylaxis. Concurrent medications included Xanax (0.25 mg, three times daily as needed). Ativan (1 mg at bedtime as needed), atenolol, Glucophage and Lotrel (5/20 mg once daily). Concurrent medical conditions included autosome dominant polycystic kidney disease with early stage renal disease and new onset diabetes. On 26 September 2008 at 09:52 the subject received a dose of FLULAVAL at 0.5 ml in the left arm. On the morning of 06 October 2008, the subject presented to the physician's office with numbness and tingling in the upper left limb that had started that morning. The subject was hospitalized on 08 October 2008 or 09 October 2008 and was paralysed including facial muscles, upper and lower limbs and respiratory muscles. The subject was on a ventilator and was unconscious. The physician stated at the time of reporting that at this point they were unsure if the subject was unconscious due to the events or due to medication she is being treated with due to having the ventilator in place. Guillain Barre Syndrome was reported. the subject was treated with intravenous immunoglobulin (dates of treatment thought to be 08 October 2008 through 10 October 2008), but the subject didn't have much response. The physician considered the events were disabling, life threatening and clinically significant or requiring intervention. In the reporter's opinion, the events were possibly related to treatment with FLULAVAL.
Arm  is sore; Arm  is red; Arm  is hot to touch; arm  is rash; Arm  i s itchy; Arm  is hard; Arm  is swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm  is sore), ERYTHEMA (Arm  is red), FEELING HOT (Arm  is hot to touch), RASH (arm  is rash) and PRURITUS (Arm  i s itchy) in a 71-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 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm  is sore), ERYTHEMA (Arm  is red), FEELING HOT (Arm  is hot to touch), RASH (arm  is rash), PRURITUS (Arm  i s itchy), INDURATION (Arm  is hard) and PERIPHERAL SWELLING (Arm  is swollen). At the time of the report, PAIN IN EXTREMITY (Arm  is sore), ERYTHEMA (Arm  is red), FEELING HOT (Arm  is hot to touch), RASH (arm  is rash), PRURITUS (Arm  i s itchy), INDURATION (Arm  is hard) and PERIPHERAL SWELLING (Arm  is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.    Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Email address provided
First  4 days: constant headache (neither Tylenol nor Ibuprofen helped), muscle aches, fatigue, weakness and inability to perform normal daily activities. Day 5: loss of appetite, stomach cramps from eating, nausea, some vomiting, and  diarrhea for 24 hours (Imodium was ineffective as was all BRAT foods), and lack of sleep. Day 6: one small diarrhea episode after eating at night an stomach cramps continued with eating,  followed by insomnia with stomach cramps and stress. Day 7:  Milder stomach cramps, continued loss of appetite and tiredness, lack of energy.
Loss of appetite, chills and fever, and the injection site is sore and painful. Dizziness.
shingles; other zoster-related conditions; This spontaneous report was received from a lawyer and refers to a patient of unknown age and gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On or about 01-SEP-2011, the patient was vaccinated at the pharmacy with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (strength, route, dosage schedule, lot number and expiration date were not reported).  On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated for shingles, and other zoster-related conditions.  As a direct and proximate result, the patient suffered and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Fatigue; myalgia; headache; This case was reported by a nurse via sales rep and described the occurrence of fatigue in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue, myalgia and headache. On an unknown date, the outcome of the fatigue, myalgia and headache were recovered/resolved.   It was unknown if the reporter considered the fatigue, myalgia and headache to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife who herself was a Nurse. The patient received a dose of Shingrix at his primary care location. The patient had similar reactions on both dose 1 and 2, which were fatigue, myalgia, headache and it lasted approximately one day. The reporter said that prior to receiving the vaccine she told the patient that the side effects could be expected from many vaccines, including Shingrix and does attribute the side effects to vaccination. The reporter did not agree for follow-up. This is 1 of the 2 cases reported by same reporter.
Patient was COVID-19 test positive on 4/9/2021.  Patient was asymptomatic.  Testing was performed pre-procedure for planned radiation treatment.  Patient reported exposure to spouse who was hospitalized with COVID-19 infection during March 2021.
Localized reaction on bilat thigh. Red, warm to touch, and swollen. Patient seen in clinic. Cool compresses instructed by physician.