chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt states she had wound from a "Bad flu shot" in 2008. She said that her lesion on her arm was from the vaccine.
Since the shot there has been a major sleep disruption/changes. She wakes up continually throughout the night/during naps.  She has clearly been uncomfortable and not feeling well. She was out of sorts, not herself, irritable & crying a lot. It started with what looked like a bug bite immediately below the injection site. Then the redness got larger & vesicles started to emerge. The vesicles got larger, she started scratching at it & it burst yesterday 7/2/2020. It currently is still red and irritated.
I started having pin and needle sensations on my fingertips about 4 weeks ago and that has never happened before and it became more and more frequent. Last week I was cooking and the tingling has gotten much worse and the fingers have gotten numb and I could not feel them. Parts of my fingers have gone pale yellow or white color like if they are lacking blood, and that lasted for about 20 minutes. It feels really uncomfortable and then they turned a dark dusty blue which lasted about 15 minutes, and then started to come back to bright red which hurt a lot. I reached out to my doctor the next day, nothing like this has ever happened before. I had a weird dizziness with this, and they sent me to the ER with this and they said that there is a disease called Raynaud's and they were quite surprised that it popped up out of nowhere. And they are not sure as to why I suddenly have this and it can be benign but other things can trigger it. So my doctor and the ER department referred me to a rheumatologist since I have more complex issues. To make sure there was nothing that has caused it.
Evening after vaccination -> (L) arm pain - flu/pneumococcal site, (L) leg pain, fever. Fever 103-104 -daily for first 4 days after vaccine, swollen upper (L) arm/hot to touch area.
Red, swollen, with a large bump, no appetite, very fussy, Needs to be tx with Benadryl & Tylenol 2-3 days
Shingles - symptoms - Went to Urgent Care  - they diagnosed with Shingles. They prescribed a medicine. It took about 10-15 days to help with the symptoms.
Very painful site of injection; lots of tiredness; This is a spontaneous report from a contactable other hcp (patient). A 40-year-old non-pregnant female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 10:45 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. Medical history included urticaria from an unknown date, food allergy (known allergies: banana) from an unknown date. Patient had COVID-19 prior vaccination. Concomitant medication(s) included fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, from an unknown start date.  On 06Mar2021, the patient had very painful site of injection and lots of tiredness. The outcome of the events was not recovered.  No follow-up attempts are possible. No information about lot/batch number cannot been obtained.
2/18/2021 as I got out of bed I realized I couldn't see well, and figured my glasses were blurry again.   Several days later noticed I did not see something in my peripheral vision to the left.  2/25 appt. with ophthalmologist: optic neuritis, referred to specialist next day appt.  2/26 Dr., neurologic ophthalmologist, ordered MRI.  Diagnosed with Optic Neuritis, loss of vision left eye, directly related to Covid  vaccine shot.  Now referred to another Dr. Neurology, further MRI and I have no idea where this will all end.  All I can say is I have been permanently damaged, and only time will tell how seriously.  I really need help with my medical bills.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 66-year-old male patient received BNT162b2 (BNT162B2), on 02Mar2021 at 12:15 as dose 2, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "heart disease" (unspecified if ongoing) and patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Jun2022, outcome "not recovered", described as "COVID 19 Treatment"; DRUG INEFFECTIVE (medically significant) with onset Jun2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (Jun2022) negative, notes: 4 days negative testing; (Jun2022) positive, notes: than tested positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course was reported as Paxlovid rebound all symptoms returned after 4 days negative testing and then tested positive. Antiviral details included that patient had COVID 19 treatment on 19Jun2022 to 23Jun2022, Lot number: FY7031. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Cough, RN, congestion, ST, ear pain, fatigue and loss of smell.
2/9 received 2nd vaccine in series. 2/10 mild headache and fatigue. 2/11 worsening headache, extreme fatigue, and general malaise. In bed except for bathroom use and minimal food consumption starting 2/11 until hospitalization on 2/17/2021.
Blurred vision when waking up the morning  at 9:00am after the shot. Sleepless night with chills, migraine, nausea and body aches. Clear vision came back after around 45 minutes.
Presented to ER on 12/28/21 . Received moderna on 03/05/21 and 04/06/21. COVID positive 12/27/21. Complaints of having diarrhea and vomiting for the past couple days.  Patient was diagnosed with COVID yesterday in her ER and left AMA prior to receiving her regeneron infusion.  When patient went home she states that she tripped on something and fell and her family member stated that she lost consciousness for a while.  She is a poor historian.  She denies feeling dizzy but states that for the past day or so she has felt like she is going to pass out.  She is unsure she took her medication this morning for blood pressure.  In the ER she is found to have an acute kidney injury, last creatinine that we have is from 2018 which is normal.  Patient had CT head and CT C-spine which was negative but it showed thyroid nodules.  Her lab work is otherwise normal.  She denies any respiratory symptoms.  She is currently saturating well on room air. Stable on 12/29/21 and discharged
Patient presented with cellulitis in right thigh at site of DTaP injection two days after DTaP applied.
Patient presented to Emergency Department with sore throat, emesis, pharyngeal bleeding, and bruising. Admitted for observation. Worsening ecchymosis noted during hospital stay on left arm, and onto right arm. Palatal enanthams noted. EKG showed septal infarct; repeat EKG the following day WNL. Upon discharge patient still c/o headache, body aches, sore throat/mouth.
TEMPERATURE EXCURSION OCCURRED DUE TO THE PLACEMENT OF HAND WARMERS IN THE INSULATED BAG USED TO TRANSPORT VACCINE. ALL 81 PERSONS RECEIVING VACCINE IN LANES 5 AND 6 AT THE CLINIC ON 02/15/20WEEN 14:00 and 16:45 WERE NOTIFIED THEY  RECEIVED VACCINE THAT WAS OUTSIDE OF THE APPROPRIATE TEMPERATURE RANGE AND WERE RECOMMENDED TO BE REVACCINATED.
Per provider report from pt appointment: "Patient presents with 3 days of rash and swelling in the right arm/shoulder after getting flu immunization 3 days PTA. Area has improved, mom had pictures. Now no distinct borders. Still swollen, tenderness is resolving. Patient to continue icing and using motrin."
Pt received AVA #1 in left upper arm on 9/29/10 (pt is right handed). Within a few seconds she felt like "she was stabbed with a hot poker". She described the pain as a 6-7/10 which lasted the remainder of the day. The next day her left upper arm was sore at the injection site (3-4/10). This pain resolved within 48-72 hours without treatment. She denied having erythema, swelling or induration in the left upper arm area. About one week after the vaccination she noted "muscle twitching" which she could see and feel at the injection site. The twitching lasted 3-5 minutes and recurred every 15 minutes to 2 hours. The pt denied pain, numbness, tingling, weakness or decreased ROM in her left arm, shoulder or hand. Additionally, she denied recent history of issues with balance, blurry vision, urgency incontinence, headache, or trauma. After about one month the episodes became less frequent. The pt had been symptom free for about one week and then had a brief episode on 1/9/11 with none since. The pt was evaluated by Neurology on 1/10/11. On PE the pt had no decreased deltoid muscle mass; no decreased left arm muscle strength; no abnormality at the injection site with inspection or palpation; normal and symmetric UE reflexes. The neurologist's assessment indicates that when components of a vaccination are approximated or injected into a nerve an isolated chemical neuritis could present as focal muscle fasciculations which would typically resolve spontaneously over months.
flared up my pseudo tumor cerebri; flared up my pseudo tumor cerebri; horrible headache; nausea; loss of appetite; diarrhea; issues with eyes sight; brain fog; This is a spontaneous report from a contactable other HCP (patient). This is the 1st of 2 reports, for the second dose. A 41-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration and administered in left arm at age of 41-years, on 01Sep2021 16:30 (Lot Number: FC3181) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Pseudo tumor cerebri and medullary sponge kidneys. Concomitant medication included acetazolamide at 500 mg Er. The patient previously took morphine and experienced allergy. Historical Vaccine included the first dose of bnt162b2 on an unknown date as DOSE 1, SINGLE for Covid-19 immunisation and experienced horrible headache and nausea, loss of appetite and diarrhea on 14Aug2021. No other vaccines within 4 weeks prior to the COVID vaccine received. The patient experienced flared up with pseudo tumor cerebri, horrible headache, nausea, loss of appetite, diarrhea, issues with eyes sight and brain fog, and all started in Sep2021. Adverse events resulted in "Doctor or other healthcare professional office/clinic visit". No hospitalization or prolonged. No treatment received. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events nausea, loss of appetite and loss of appetite was recovered in Sep2021; of remains events was not recovered.  The clinical course was reported as follows: Got my shot on Wednesday and by Saturday I had a horrible headache and nausea, loss of appetite and diarrhea. The stomach issues lasted a few days but headaches still on going. This happened with both shots and got worse with the second. This shot flared up my pseudo tumor cerebri.  Still having issues with headaches, eye sight and brain fog.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events idiopathic intracranial hypertension and disease recurrence and the suspect drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101242585 same patient/product, different dose/events.
Fever, chills, fatigue, body aches- moderate for 36 hours following injection. Pain at injection site for 10 days following injection. Ringing in ears on 4/7.
Fine macular rash over torso, arms, and neck. Not itchy or painful. Treated with IM benadryl. Pt monitored for 2 hours without improvement or worsening of rash. No other symptoms.
after the second dose of the vaccine, urticaria started to appear in a very strong way. I was too close to get in shock, I had to visit an emergency clinck. everything started after the second dose and since then it didn't go well. each day I had more symptoms
Stomach pain, sharp pain in the right side of stomach; Vaccination site pain, arm hurt after vaccination; Headache; Weakness; Generalized aching, body aches; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (Weakness), PAIN (Generalized aching, body aches), ABDOMINAL PAIN UPPER (Stomach pain, sharp pain in the right side of stomach), VACCINATION SITE PAIN (Vaccination site pain, arm hurt after vaccination) and HEADACHE (Headache) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In 2021, the patient experienced ASTHENIA (Weakness), PAIN (Generalized aching, body aches), VACCINATION SITE PAIN (Vaccination site pain, arm hurt after vaccination) and HEADACHE (Headache). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain, sharp pain in the right side of stomach). In 2021, ASTHENIA (Weakness), PAIN (Generalized aching, body aches), VACCINATION SITE PAIN (Vaccination site pain, arm hurt after vaccination) and HEADACHE (Headache) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain, sharp pain in the right side of stomach) had resolved.            No concomitant medications were reported. No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Information has been received from a physician's assistant (PA) concerning a 39 year old Hispanic female with no medical history who on 08/05/03 was vaccinated IM in the left deltoid with the first dose (0.5mL) of hepatitis B virus vaccine rHBsAg (yeast)(Lot # 645620/0218N).  There was no concomitant therapy or illness at the time of vaccination.  The PA reported that on 08/06/03, the pt developed an allergic skin rash on the left side of her neck.  On 08/15/03, the pt presented to the clinic with erythematous papules on the lateral part of her neck.  The pt was treated with 25-50 mg of diphenhydramine HC1 (Benadryl) twice daily as needed.  On 08/17/03, the pt was placed on oral prednisone and a topical cream.  No lab/diagnostic tests were performed.  Subsequently, the pt recovered.  On 10/01/03, the pt presented to the clinic.  At that time, no further symptoms were noted.  The PA did not believe the pt's events were caused by Hepatitis B virus vaccine rHBsAg (yeast).  No further information is available.
anaphylactic shock, hives,difficult breathing, arthritis, MVP, ulcers then eventually SLE;Annual follow-up received on 02/15/01 states the pt has skin rash, repeated allergic tendencies, arthralgis.
At 11:59 a.m., the patient's younger brother reported to RN, that patient had fainted. RN witnessed patient supine on the floor, with her head in her mother's lap. Patient's head was placed flat on the floor and her  feet were elevated on a box. Patient's face was pale, but she was not in respiratory distress, and she was responsive to questioning. No hives, swelling of lips/face, no complaints of throat tightening, or itching. Patient did report burning ears, tingling hands, and slight nausea. Vital signs at 12:03 p.m.: blood pressure (BP) 126/76 mmHg, pulse (P) 84 beats/minutes, and respirations 22 minute. At 12:08 p.m., BP 118/70 mmHg, P 66 beats/min, and R 18. Patient stated she had not eaten breaksfast this morning. She was assisted to a sitting position on the floow and was given fruit punch and a protein Bar. At 12:21, Patient was assisted to a chair. At 1224, BP110/68, P60, R16. At 12:25pm, Patient stated she felt better. At 12:30 pm, she was assisted to her feet by her parents. Patient stated she felt fine.
started out w/fever that kept inc to 103 w/APAP & supp; then vomiting started around 5PM; temp down to 102 by 7PM then by 10PM t105 notified MD who advised bath;
Heavy tired legs, Excessive sleep, Fatigue No fever, no appetite. The fatigue was so bad I could not leave bed for 4 days. When I did walk (only to the restroom) it was painful and done very slowly. I had to steady myself using the wall, and when I laid back down it felt like I had just run a marathon.  I was not running a fever, so chose not to seek emergency treatment.  I saw my doctor on 4/13, she said it may have been the vaccine, as I am an otherwise healthy adult with no chronic conditions.
I woke up with a prevalent cough, I thought maybe I had a cold so I did an at home test which came out to be positive. I ended up finding some cough syrup to help with the cough. I talked with my doctor who offered Paxlovid but I decided to not take the Paxlovid.
Arm started to really ache.  Started to get a toothache in the left hand side of my jaw that was extremely intense and it (pain) traveled up the check and into nose.  Throat started to close.
Very small raised spot at injection site for Varicella (RA/SC). Spot appeared 10 days after injection.
This spontaneous case reported by a consumer, describes the occurrence of headache in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced a headache. At the time of the report, headache outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported. The patient wanted to know if she could take ibuprofen for a headache.
Arrived at ER 8/15/2022, tested Covid+ with home test 8/14/2022, reported 7 days history of sore throat, increased SOB. Upon arrival at ER SpO2 76% RA. Placed on 5L O2/NC. Temp 100.5. Also found to be in Afib with RVR. Covid PCR + on 8/15/2022.
PT HAS A RASH ON HER BACK THAT KEEPS COMING AND GOING AND IS VERY ITCHY.  IT STARTED RIGHT AFTER 2ND DOSE OF SHINGRIX. MD IS TREATING WITH TRIAMCINOLONE
pt experienced headache, nausea, and fever the day after vaccination which was to be expected but she also experienced a rash starting with the vaccinated arm moving across her chest then down the other arm.  She also experienced shortness of breath.  She stated she took benadryl every 2 hours for the rash which controlled it and monitored herself with the shortness of breath.  She also stated that since she was asthmatic if the shortness of breath would have gotten worse she would have gone to the ER (luckily this wasn't necessary).
headache; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; FATIGUE (non-serious), outcome "unknown", described as "fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2011, the patient was inoculated with ZOSTAVAX at a family practice office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 14-SEP-2016, the patient was treated at a dermatology office for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
SORENESS REACTION IN THE ARM; This spontaneous report received from a patient via a company representative concerned a 69 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: type ii diabetes. The patient was previously treated with bnt 162 for prophylactic vaccination. 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 on 24-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced soreness reaction in the arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness reaction in the arm. This report was non-serious.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age, who in March 2012, was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscularly (lot number and expiration date were not reported) and on 01-JAN-2013 was vaccinated with the second dose of GARDASIL 0.5 ml, intramuscularly (lot number and expiration date were not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Case number PHEH2014US021285 is an initial spontaneous report received from a nurse on 20 Oct 2014. This case refers to a 14-year-old female patient. past medical history and concomitant medication were not reported. She was vaccinated with FLUCELVAX (batch number: 013011A), at dose of 0.5 ml intramuscularly on 17 Oct 2014. No adverse event was reported following this administration error.
pt recv vax 28JAN99 & 31JAN99 pt exp muscle aches & weakness & pain when trying to lift the arm;
Weakness, feeling tired, feeling of numbness all bilat entire body.  Kept feeling weak, wanting to fall asleep.  Nausea developed.  Symptoms non resolving.   BP 100/60, p.80, r-18.  No distress.  AOx4.   EMS activated, transported by ambulance to hospital.