chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and follow up information has been received from a physician and a father concerning a 11 year old male student who on 04-NOV-2008 at 10:15 am, was vaccinated with the first dose of GARDASIL (Lot No 661764/0650X) in the left arm. Concomitant vaccination on 04-NOV-2008, included FLUZONE (Lot No U2799AA). The physician reported that inadvertently the GARDASIL was give to the patient instead of the patient's sister. At the time of the report no symptoms were reported. No further information is available.
My arm was very red and swollen the next day, Also started to bruise. I took Allegra and put ice on it. ( Saturday and Sunday). Looks much  better today. Not red and swelling is down
Pt reported that at the age of 12 she was diagnosed with Behcets disease and prior to her most recent flare in July 09 her last flare was severe, 4 yrs ago at age 19. From 12-19 she would have a mild flare every 2 yrs. She stated that about 10 days post immunization she had some abd discomfort, that became sever in Jul. She also reported blurred vision and burning in her mouth and esophagus. She reported that with each previous immunization a small keloid would form at the vaccination site. She also expressed concern re:the appearance of her SPV site. She described the skin over the site as raised, smooth, pink and shiny. She reports itching, tenderness to the site and that it appears to be getting larger. Symptoms: blurred vision, Odynophagia, Nodule, subcutaneous, Abdominal pain. 12/4/2009 MR and DC summary for 7/8-7/9/2009, patient with c/o's arthralgias, pleural, pharyngeal, and abdominal pain. Tx: Rheumatology consult for Behcet's disease, tx'd with IV Solu-Medrol and started on Colchicine.
Next day post vax, the pt developed an injection site reaction characterized by redness, inflammation, swelling, and warmth.
Almost immediate headache, migraine-like. Patient has history of migraine. Took 2 extra strength TYLENOL. Symptoms subsided after about 20 minutes-40 minutes.
A low grade fever (approx. 101 deg F) started about 11-12 hours post-injection accompanied by fatigue, head ache and general body ache.  Adverse event began to subside after about 24 hrs. post -injection with all symptoms being gone after 36 hours post-injection.
shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was provided regarding medical history, concurrent condition, or concomitant medication.  In 2015, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dose, dose number and route was not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles and was hospitalized. On an unspecified date, the patient was treated by a physician for shingles.  As a direct and proximate result of the patient's use of the zoster vaccine live(ZOSTAVAX) vaccine, the patient had and would 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 would continue to suffer such losses, and damages in the future.  The outcome of the shingles was not reported. The reporter considered the shingles to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
80 yo male patient with a past medical history of HTN, HLD, DM2, CAD s/p PCI, ocular stroke (right eye), basilar artery aneurysm, anxiety, remote T7/T9/T12 compression fx c/b chronic back pain, and cervical canal and foraminal stenosis. He is s/p full Pfizer vaccination: first dose on 1/21/21, second dose on 2/11/21. Pt initially presented to the ED on 4/28/21 with an approximate 2 day history of diffuse proximal weakness and leg pain. MRI C/T/L spine was obtained that showed multilevel degenerative disease without significant stenosis to explain abnormalities. MRI brain and MRA head/neck were negative. Laboratory evaluation with CK, ESR, CRP, lyme, and antibody workup was unrevealing. Lumbar puncture on 5/5/21...was without CSF pleocytosis but with elevated protein to 61. He underwent an EMG on 5/3/21 that showed a mild sensorimotor axonal neuropathy. Neurology and rheumatology was consulted and felt secondary to Guillain Barre syndrome. Unclear if GBS caused by vaccine. He underwent HD catheter placement on 5/6 and received 5 sessions of PLEX (last 5/17).   He underwent inpatient rehabilitation from 5/19/21 through 6/3/2021 after which time he was discharged home.  Participated fully in the program and by the time of discharge had improved significantly in regard to function and functional independence.  He will still continue with outpatient therapy after discharge.    Since discharge home, he has been doing very well, he has not been hospitalized but did have an x-ray of his right knee which showed some osteoarthritis.  He is having some knee pain when he ambulates.
Mother reports temp 101-103 12/8 abd 12/9/05. 12/10 vomiting, sunburn rash, temp 101-103. Rash on trunk, neck, arms, thighs 12/11/2005. Noted 2 pox marks on chin. 12/12/05 temp 100's no new pox areas. Sunburn rash fading child seen at prompt care 12/10/05.
Mother states child had a seizure that lasted about 2 minutes.  Pt seen in ER after this happened.  Mother states that child had never had any other previous seizure activity.  Mother states that since the seizure the child's eyes roll back in her head and she has had some wheezing episodes.
Dad call office. Patient went to ER for reaction to immunizations. Put on antibiotic and prednisone 10/28/06 doing 50% better today
This spontaneous report as received from a registered nurse regarding a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in 2016, the patient completed GARDASIL series. On 28-JAN-2019, the patient was vaccinated with GARDASIL 9 (route, lot#, expiry date unknown) for prophylaxis inadvertently after completing the GARDASIL series (accidental exposure to product). The patient had no adverse effects (no adverse event). No PQC was reported.
This spontaneous report has been received from a registered nurse concerning to a 48 year old female patient with almonds, pollen and mold allergies. The patient's medical history included acne. On an unknown date, the patient was vaccinated with the first dose of MMR II (dose, lot # and route not reported). On 15-DEC-2010, the patient was vaccinated with a second dose of MMR II (dose, lot # and route not reported). On 22-JUN-2013, titers were drawn with a negative result for measles. On 01-JUL-2013, the patient was vaccinated with a third dose of MMR II (dose, lot # and route not reported) and on 18-SEP-2013, the patient was vaccinated with a fourth dose of MMR II (dose, lot # and route not reported). On 06-AUG-2013 with a negative titer result for measles and on 26-NOV-2013 with a negative titer result for measles. Concomitant therapies included spironolactone (manufacturer unknown) and unspecified birth control medication. The outcome of measles antibody negative was unknown. Additional information is not expected.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 22-AUG-2015, the patients was inadvertently vaccinated with an expired dose of PNEUMOVAX23 (Lot # K004542 exp date 19-AUG-2015) (dose and route not reported). No adverse effects were reported. Additional information has been requested.
I was immobiled around  7:30. For 3 days I was unable to cope with side effects. I had a headache, body aches, neaseua, Dry heaves, chills sore arm, Droopy eyes. A feeling of all over fatique , after 5 days I broke out on my chest with a itchy rash, still had  headache and neausea. Went to walk in heatlh clinc  2/11/21 Diagnosis was  Viral syndrome  post covid vaccination.
Mild rach all over the body; This is a spontaneous report from a contactable consumer (patient). A 12-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 23Jul2021 10:00 (Lot Number: FA7484) (at age of 12-years-old) as dose 1, single for covid-19 immunisation. The patient had no medical history or known allergies. The patient did not receive any concomitant medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have Covid prior vaccination and was not tested for Covid tested post vaccination. The patient experienced mild rash all over the body on 23Jul2021 17:00. The patient did not receive the treatment for the adverse events. The outcome of the event was not recovered.
died about a month ago; two weeks after testing positive for the virus; two weeks after testing positive for the virus; This is a spontaneous report from a non-contactable consumer.  An 80-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at SINGLE DOSE for covid-19 immunisation.  Medical history included pre-diabetes and atrial fibrillation (Underlying health issues). The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient died about a month ago, two weeks after testing positive for the virus. The death occurred about four weeks after the second dose of the Pfizer/BNT vaccine. The patient died on an unspecified date.  It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Deceased
COVID INFECTION; STOMACH GURGLING; BURPING; SLEPT ALL DAY; BRAIN FOG; 2 NIGHTS OF BAD DREAMS; TALKING IN SLEEP; BROKE INTO A SWEAT/ SWEATED TERRIBLY LAST NIGHT; VIVID DREAMS; This spontaneous report received from a patient's wife concerned a 53 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered to right arm on 02-APR-2021 around 15:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 03-APR-2021, the patient experienced 102.7 fever, some dry cough. Laboratory data included: Body temperature (NR: not provided) 102.7 F. On 04-APR-2021, the patient experienced chills, broke into a sweat and had vivid dreams. Laboratory data included: Body temperature (NR: not provided) 102 F, 101 F. On 05-APR-2021, the patient also had brain fog, two nights of bad dreams, talking in sleep, back pain, fatigue, slept all day. Laboratory data included: Body temperature (NR: not provided) upto 102.7 F. On 06-APR-2021, the patient experienced stomach gurgling, diarrhea, weakness, burping, body ache. Laboratory data included: Body temperature (NR: not provided) 101 F. On 06-APR-2021 03:40, Laboratory data included: Body temperature (NR: not provided) 102 F. On 07-APR-2021, the patient experienced muscle aches, back ache was at level 9, sweated terribly at night and the patient went to urgent care and they did flu test. Laboratory data included: Rapid influenza diagnostic test (NR: not provided) Negative. On 08/Apr-2021, the patient had stomach still gurgling, back ache was at level 9, tiredness, weakness, achiness, brain fog, fever was back at a 100F and diarrhea. On the same day, the patient was tested positive for Covid-19 (coded to confirmed Covid-19 Infection: chills, fever, muscle aches, joint pain, diarrhea, back pain/ back ache, dry cough, fatigue/ tiredness, weakness, and body ache/ achiness). Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 12-Apr-2021 he was hospitalized. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from brain fog, Covid infection, stomach gurgling, and broke into a sweat/ sweated terribly last night, and the outcome of 2 nights of bad dreams, talking in sleep, vivid dreams, slept all day and burping was not reported. This report was serious (Hospitalization Caused / Prolonged). Initial information was received on 07-APR-2021. With additional information obtained via telephone follow up from a wife on 15-Apr-2021 case was assessed as serious.; Sender's Comments: 20210413330- Covid-19 vaccine ad26.cov2.s- Covid infection. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Second dose / on 3/3/2021 and received the first dose 7/2020; Chills; Bodyaches; Headache; Nausea; This case was reported by a consumer via call center representative and described the occurrence of chills in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose was received on an unknown date in July 2020).   On 3rd March 2021, the patient received the 2nd dose of Shingrix. On 3rd March 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. In March 2021, the patient experienced chills, general body pain, headache and nausea. In March 2021, the outcome of the chills, general body pain, headache and nausea were recovered/resolved. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the chills, general body pain, headache and nausea to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for himself. The patient received the 2nd Shingrix dose, late than the recommended schedule, which led to lengthening of the vaccination schedule.  After vaccination, the patient developed chills, body aches, headache and nausea. The patient stated that he felt better and all symptoms were resolved at the time of reporting. The reporter consented to follow up.
sore at the injection site; Extreme tiredness; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Mar2021 09:42 (Lot number: EN6205) at the age of 75 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Overactive Bladder" (unspecified if ongoing); "Estrogen Since hysterectomy" (unspecified if ongoing); "Estrogen Since hysterectomy" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "Acid reflux" (unspecified if ongoing); "vascular Problem in lower legs & ankles" (unspecified if ongoing). Concomitant medication(s) included: MYRBETRIQ taken for hypertonic bladder (ongoing); ESTRADIOL taken for blood oestrogen (ongoing); FEXOFENADINE taken for hypersensitivity (ongoing); FAMOTIDINE taken for gastrooesophageal reflux disease (ongoing); FLONASE SENSIMIST ALLERGY RELIEF taken for hypersensitivity (ongoing); VASCULERA taken for vascular pain (ongoing). Vaccination history included: Bnt162b2 (1st Dose, Anatomical Site of Injection: Left Arm,, Route of administration: Intramuscular, Batch/Lot Number: EL3247), administration date: 09Feb2021, when the patient was 75 years old, for COVID-19 immunization, reaction(s): "couldn't move arm out to side", "extreme headache", "extreme tiredness". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "sore at the injection site"; FATIGUE (non-serious), outcome "unknown", described as "Extreme tiredness"; HEADACHE (non-serious), outcome "unknown", described as "headache".  Additional information: The patient believe the error uses in the administration of the vaccine. She jabbed me quite firmly and it may have not been quite in the right placed. It was extremely pain full and felt all the vaccine going into my arm. After ward realized I couldn't move my arm away from body more than it has lasted 5 days also had severe headache, tiredness. In comparison, when I got my 2nd vaccine, never felt the injection and I could move my arm in all direction. It was just sore at the injection site like a Flu shot was. I did have the extreme tiredness and headache as I did with 1st vaccination for several days.  No follow-up attempts are possible. No further information is expected.
The patient called and said she had experienced severe flu like symptoms (fatigue, headache, chills) and pain and tenderness in armpit area for 2 days after the vaccine was given. Symptoms were improving when she called to report them but they were still present.
Within about 12 hours, mild to moderate soreness at site of injection, headache, muscle aches and fatigue.  Symptoms lasted less than 12 hours and were relieved with one dose of Tylenol.
Soon after receiving shot, PT experienced dizziness and felt like she was going to pass out, medical team arrived to assess. PT was conscious but shortly thereafter, she had a tonic-clonic seizure. This lasted about 2 minutes, then she was post-ictal for about a minute. Then PT was able to answer questions appropriately and knew where she was. V/S were normal including a BP of 105/70, SPO2-100%, HR-70. EMS was called to transport to ER. Over the next several minutes, PT felt dizzy and tingly. She remained stiff in extremities and had a hard time verbalizing, trying to say that her tongue felt stiff. When EMS arrived, they took her blood sugar, which was 120. She was then taken to ER for further evaluation.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD DISORDER (non-serious), outcome "unknown", described as "I've read and seen that covid/covid shot cause blood issues". Additional information: It was reported by reporter "I went to an urgent care they said the red bumps on my upper legs was purpura they said it will go away in 2 weeks. Went urgent Care in Jan2022. Dr Diagnosed Internal Shingles. Also had No itchy bumps end of the internal Shingles. Then got COVID Mar2022. End up with the same non itchy bump. went to an urgent Care they said it was purpura that it will go away in 2 weeks. But they came back again and gone. I got the internal shingles from the COVID shot. It messed with my DNA. I had 3 Doctors tell me they seen cases that COVID and shingles are similar. They seen patients with COVID and shingles together. Sorry for the difficulty with results. Your labs including electrolyte, liver, kidney, are all normal. Overall your blood counts are normal as well. Your lymphocytes were 0.2 less than normal which is likely transient (not caused by anything) and will improve on its own. I would like to recheck it in one month to make sure it improves. Thanks. What was wrong on my lab. I did called the office but I did not get all the information because I didn't hear her. I tried to look it up in my results and didn't see it in there. Thank you, Ever Since COVID Shot I got Internal Shingles then COVID my lymphocytes less than normal. COVID shot messed my DNA? Now I'm getting purpura it will come and go and Which is when Small blood vessels Leak blood under the Skin's Surface. which I've read and seen that COVID/ COVID Shot Cause blood issues. What is not fair all those Dr's visits and urgent care visit I'm paying for. I wish I Never got the COVID Shot. I am Not getting the 3rd Shot. This shot is not approved. If you using my Info for a steady I want to get paid. Then the purpura is from it all".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I started feeling intense joint pain by mid June.  I find great difficulty using my hands and walking. My joints are stiff and my fingers lock up.  My hands and feet are slightly swollen, but I can?t wear my rings and only a few pairs of my shoes.  I hurt all day long and especially in the morning.  I have trouble doing very simple tasks like opening jars etc.  I am also very fatigued.  I have low energy and am tired all of the time.  This is unusual for me because I am generally a very healthy, active person who has always been able to enjoy outdoor and sporting activities with ease.  I am now limited to what I can do and how long I can engage in extracurricular activities as well as simple tasks at work.  I had a Dr. appointment on June 10, 2021 for a physical and expressed my concerns. My doctor requested blood testing for Rheumatoid Arthritis and the results were negative.  She prescribed Celebrex and Voltaren, but I?m not getting any  pain relief from using either.
No additional AE reported; the patients that were administered the vaccines involved in the temperature excursion; This spontaneous report has been received from a pediatric office clinical coordinator, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not reported.   On 10-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number T032930 has been verified to be a valid lot number, expiration date reported and established as 28-SEP-2022) as prophylaxis.   The vaccine was exposed to a temperature excursion of 15.7 degrees Fahrenheit (F) during a time frame of 35 minutes; with no previous temperature excursion. No additional adverse events reported.  This is one of multiple reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA004580:Original Case : 2108USA003330 US-009507513-2108USA004581:Original Case : 2108USA003330 US-009507513-2108USA004582:Original Case : 2108USA003330