chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient states that 13 days after her vaccine, she had swelling in her ankles.  She states that at that time she called her cardiologist who ran bloodwork and noted an elevated creatinine.  He prescribed HCTZ to her and she states the swelling went "mostly" down.   She then states that she began to have pain in her joints all over her body.  She called her PCP who did more bloodwork and noted an elevated Rheumatoid Factor.  She has been referred to an rheumatologist but states that her appointment is not until 8/13/20.  She presented to the pharmacy today (7/26/20) to discuss this adverse event. She states she takes advil daily with relief from that.   Provided patient phone number to GSK, advised patient to keep rheumatology appointment and let patient know we would report these symptoms.
Confusion, Dizziness, Headache, Myalgia, Arthralgia, NauseaVomiting & HYPOglycemia Narrative:
This spontaneous report was received from a registered nurse concerning an unspecified number of patients of unknown demographics. On an unknown date, unspecified number of patients were vaccinated with improperly stored doses of VAQTA (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. No symptoms were reported. Follow-up received from a registered nurse. The reporter stated that the lot# and expiration date for VAQTA was J002347, expiration date 04-SEP-2013. A 2-year old patient, gender unspecified was vaccinated on an unknown date. This is one of the several reports from the same source. Additional information has been requested.
NEXT MORNING: CLT HAVING DIFFICULTIES BREATHING, PRESSURE ON CHEST. HARD TO TAKE DEEP BREATH. NAUSEATED. HEADACHE. WEAK. PAIN UNDER ARM WERE SHOT WAS GIVEN.
Pt reports pain in right upper arm 2 months after receiving TD in 03/24/03.  Pain has persisted and now sometimes has difficulty using right hand.  Also has developed pain in left arm and both legs.  MD ruled out "muscle disease" and has diagnosed arthritis.  Please find to follow a completed VAERS form.  This pt was seen at the health department on 03/24/03 for a TD immunization after cutting her finger on a rusty wire.  I had not heard from her since that day until 04/12/04.  She called on that date and reported that she had developed pain in her right arm 2 months after receiving the injection.  She reported that the pain became much worse, eventually expanding to her other arm and both legs.  She feels that she has difficulty picking up objects with her right hand and attributes all these symptoms to the injection.  She saw her MD on 03/04 who allegedly performed some testing to rule out "muscle disease".  He felt the symptoms were due to arthritis.  The pt persists in believing the problems are a result of the TD immunization.  She came into the clinic today and I provided her with the Lot #, manufacturer, etc of the vaccine for a VAERS she had completed.  She is now saying the symptoms began immediately and included redness and tenderness at the injection site.  She also reports receiving a flu shot and pneumonia shot in 2001, which made her very ill and caused her to temporarily lose the hearing in her right ear.  In the interest of thoroughness, I completed a VAERS, even though based on the symptoms she initially reported to me, it does not fit the description for a reportable event.  Please do not hesitate to contact me if you have questions or require clarification.  Thank you for your assistance.
Migraine, 103 degree fever, fatigue, 7AM to 9PM the next day (saturday), took tylenol, Sunday had a 99 degree fever
Pt to ED 11/13 for cough and hallucinations, concern for UTI. 11/16 pt more confused than usual & "twitching", temp was 102.6. Pt COVID+ 11/17, pt with Cough/rhinorrhea, no evidence of pneumonia, pt to complete 3 d remdesivir. Pt discharged 11/20.
Cellulitis - pain restricting movement - not reported to Employee Health for 10 days.
Fatigue; headache; arm pain from shoulder to elbow; This is a spontaneous report from a non-contactable consumer (patient). A 37-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (left arm) on 24Jan2021 at 09:30 at a single dose for COVID-19 immunization.  Medical history was reported as 'none'. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no medications received within 2 weeks of vaccination. The patient experienced fatigue, headache and arm pain from shoulder to elbow on 25Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment administered for the events. The events were resolving.   No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Information has been received from a licensed practical nurse concerning a patient of unknown age and gender. On 24-NOV-2015 and 20-MAY-2016 the patient was vaccinated with the first and the second doses of VAQTA (dose and route unspecified), lot # L015460 (dose 1) with expiration date 20-JUL-2017 and lot #L023232 (dose 2) with expiration date 25-FEB-2017, respectively. The nurse stated that the 2nd dose was a couple of days shy of the minimum interval of 6 months (inappropriate schedule of drug administration). No adverse effects were reported. Additional information is not expected as the reporter did not wish to be further contacted.
Routine covid 19 vaccination using Pfizer requested by patient.  All screening questions were answered by patient and received the vaccination without incident.  Approximately 3 minutes after she received vaccination she came back in the professional services room with her father, as he received his vaccination she complained of becoming dizzy and was told to go have a seat in the waiting area.  She was sitting with her mother for another moment and her mom became concerned because the patient urinated on the floor while she was sitting there and seemed to lose consciousness.  We responded to the patient who was awake but was extremely pale.  Warehouse management was called over and they observed the patient and made the decision to call 911 based on the mother's concern.  Paramedics arrived within 10 minutes and recorded very low blood pressure and were concerned she may have had a seizure.  The decision was made to take the patient to the hospital because her blood pressure was still remaining low after approximately another 10 minutes.  I called the phone number on her immunization consent form the next morning (6/15/21) and again in the evening but was able only to leave a voice mail.
Development of DVT w/ massive saddle pulmonary emboli requiring mechanical thrombectomy. R carotid artery emboli as well as R subclavian emboli w/ pulseless arm also requiring mechanical thrombectomies. Multiple showering CVAs/strokes.
At 1248am, I fainted, had possible seizure, unconscious for 1 hour, several months of testings, Dr's can't find what's wrong, since vaccine have several daily headaches, nausea, dizziness, difficulty thinking, depression, abdominal pains, extreme fatigue, no symptoms have improved. After faint, left arm and left leg became numb for approximately 5 hours.  5/14/09 Vax rec received from provider.  HPV#1 7/3/07 0523U.  HPV#2 7/15/08 1757U. HPV#3 11/17/08 0651X. Neuro consults date 11/19/08 and 12/17/o8 received with dx:  syncopal episode, cervicalgia, headaches, mild anxiety, obesity. Pt presented for eval following syncopal episode (? vasovagal, cardiac or seizure) 2 days prior. Now with c/o H/A, numbness of the face, lips and neck-mostly on the L and dizziness. C/o "fogginess" on 12/17/08.  8/13/09 ER records received DOS 11/18/09. Assessment: Dizziness and Giddiness. Syncope and Collapse.  Patient presents with anxiety and head trauma. States "I woke up on the floor". Does not remember falling on the floor. Last memory was going to bed. Bruise left cheek. Tenderness. Internal lacerations left side of mouth/lips. Hematoma. Headache.
Feeling of being poked, similar to a needle or several splinters. First day was only in arms. Second, third and fourth day is moved to abdomen but mainly in lower body. Symptoms worse at night and with touch of clothes or blanket.
24 hours post vax, the pt developed mild erythema at injection site and swelling from thigh to knee.
Virus like Symptoms (coxsackie B)  - including mouth ulcers / skin rash / heart problems / hard palate and soft palate infection / fatigue / pain /  Two courses of antibiotics / 5 doctors visits / CT Scan Sinus and Neck / Heartbeat problems / autoimmune type reaction. Ongoing problems for 42 days plus. Follow-up received via e-mail  on Wednesday, May 12, 2010 3:31 PM states - OK will gather info and forward to you. Waiting for some more test results from lab.
Date of Admission: 5/24/2023  Discharge Date:  05/27/2023 Discharge Disposition: Skilled Nursing Facility (SNF) with Certification in Anticipation of Skilled Care PMH:  of cerebral palsy, coronary artery disease status post PCI, heart failure with preserved ejection fraction, diabetes mellitus, chronic GERD, history of PE status post IVC filter and currently on warfarin, hypertension, hyperlipidemia, tremors, BPH, who presented with increasing weakness.  Patient is currently asymptomatic from this regard. breathing well on ambient air. supportive care.    030A21A  3/4/2021 036B21A 4/6/2021
Headache, nausea, fever, aches, dizziness  following vaccine. Dizziness with episodes of fainting continue  Per pediatric cardiologist - autonomic nervous system dysfunction (dysautonomia/POTS); Rx for Fluoxetine
arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was sore) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history information was not reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm was sore). At the time of the report, VACCINATION SITE PAIN (arm was sore) outcome was unknown. Not Provided          Concomitant product use was not provided.  No treatment details were reported.    This case was linked to MOD-2021-016954 (Patient Link). This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021 and was forwarded to Moderna on 19-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was sore) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history information was not reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm was sore). At the time of the report, VACCINATION SITE PAIN (arm was sore) outcome was unknown. Not Provided          Concomitant product use was not provided.  No treatment details were reported.    This case was linked to MOD-2021-016954 (Patient Link).
Full day of fatigue and full-body muscle aches starting about 6 hours after injection and lasting ~30 hours. Bad enough to put me in bed for a day. Symptoms cleared on their own after the second day.
When running short distance felt like out of breath; Itching on both arms/Generalised itching; Arms becoming reddish; Sweating; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching on both arms/Generalised itching), ERYTHEMA (Arms becoming reddish), HYPERHIDROSIS (Sweating) and DYSPNOEA (When running short distance felt like out of breath) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939893) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced PRURITUS (Itching on both arms/Generalised itching), ERYTHEMA (Arms becoming reddish) and HYPERHIDROSIS (Sweating). On an unknown date, the patient experienced DYSPNOEA (When running short distance felt like out of breath). At the time of the report, PRURITUS (Itching on both arms/Generalised itching), ERYTHEMA (Arms becoming reddish) and DYSPNOEA (When running short distance felt like out of breath) had not resolved and HYPERHIDROSIS (Sweating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications were not reported. The treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Added new event, event onset date, outcome  and updated patient details and reporter information.
Monday September 13, I had a lot of pain in my arm and cramps up to the tips of my fingers. In the afternoon I noticed my arm was very swollen in the area around the vaccine (approximately 2 inches in diameter, and 1/4 of elevation inch) the area was very red, I applet ice. The same day I took 3 doses of Acetaminophen with a gap of 8 hours between 1 and 2 and a gap of 6 hours between 2 and 3 since I had fever. Tuesday September 12 I did not apply ice to the area, the area of the arm remains inflamed and red. Cramps continue but is less frequently. Wednesday 15 and Thursday 16 September, I apply ice at night, the area continues with the same inflammation, the color begging to look slightly darker and less red. Very itchy in the area. Friday, September 17, the area still inflamed when I touch it feels hard. There is no pain but suddenly it gets very itchy. There's only pain around the inflammation.
This spontaneous report was received from a pharmacist referring to a 51 year old female patient with no known allergies listed. On 19-MAY-2014, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml subcutaneously in the left arm (lot # J012660, expiration date 10-JAN-2015). The patient called the pharmacist who stated that on the next day post vaccination, on 20-MAY-2014, the patient developed reddened rash at the injection site of left arm. The site was growing in circumference and was warm and painful when touched. Pharmacist stated he recommended the patient to contact her primary health care provider. No treatment was given for the event at the time of the report. The outcome of reddened rash at the injection site of left arm was reported as not recovered/not resolved. Additional information is not expected.
I got my Shingle vaccine at A Pharmacy around 10:00 am on 08/15/20.  All day I soreness around my injection site and by around 11:00pm or midnight when I went to bed my entire body from neck  to my ankle  was aching badly to the point that I was not able to move because of the severe pain.  I reported my reaction to the pharmacist at Pharmacy and she asked me to reported to my doctor. I notified my Dr. office  and they never got back with me, and couple of days later I started having internal tremors started in growing area and  then few days later  my whole body. This internal happens at night time and is still continuing. I saw  neurologist and reported the issue and again followed up with different doctor and have another appointment with different neurologist to see if he can finds out.
Patient reported that the vaccine felt like it went into the bone in her shoulder. It was painful the next day and continued to worsen, by 10/17 she felt ill and had low energy. That week she was seen twice in urgent care, first time was prescribed a prednisone taper (60mg decrease by 10 mg daily) she went back and was given doxycycline, and then went to her pcp on approximately 10/21 and found to have elevated sed rate and CRP and was referred to the Hospital where she had a tap of her shoulder that grew staph aureus (MSSA) and that evening had extensive surgical debridement.  I believe she was inoculated with MSSA from her vaccine injection, and the clinical symptoms were masked by the prednisone and could have been even more serious than it was. I informed the pharmacy and they had not heard of any other infections in other customers. Hospital Course:   The patient was taken to the operating room on 10/22/2021 for a right shoulder irrigation and debridement by the doctors. See the dictated operative note for full detail. There were no complications during the surgery. Postoperatively, patient was admitted to the Orthopedic floor. She was given empiric antibiotics. Infectious disease was consulted and recommended prolonged course of IV ancef.  She was started on DVT prophylaxis (ASA 81 mg bid), given TEDS/SCDs, and encouraged early mobilization. She was started on a bowel regimen, tolerated a diet, and voided appropriately prior to discharge. The shoulder drain was removed on POD1. She was seen by Physical therapy, Occupational therapy, and Case management who together recommended a plan for discharge. She received a midline for delivery of long term antibiotics. On 10/28, she was referred for LUE DVT ultrasound due to left arm swelling and pain. This revealed thrombus in the left basilic vein and left cephalic vein. The midline was removed and she instead received a tunneled central catheter by VIR. Hematology was consulted and recommended Eliquis 10 mg twice daily for 7 days followed by 5 mg twice daily for a total of 3 months.   She was seen by the Orthopedic Surgery team on 10/29/21 who felt that the patient was medically and surgically stable for discharge. She was discharged with a midline catheter in place and home services for prolonged IV ancef.      She was discharged home on 10/30/21 She is still recovering and has lost much ROM in her right shoulder
Head ache, Chill, Fever (100.4 to 100.80), Body ache, Light burning eyes, loss test for 2 days. Took Tylenol x2 (500mg) for 2 days.
Medical Assistant mistakenly given Hep A vaccine dose to patient.  The doctor ordered Hep B to be given to the patient.
Admitted 1/14/21: Patient is an elderly 93-year-old female with multiple medical problems including chronic combined CHF, P 80, diabetes mellitus, HTN, hyperlipidemia, CKD stage 3, has been complaining of generalized weakness, fatigue, decreased appetite for the past few days.  She had an outpatient COVID-19 vaccine earlier today. Within 2 hr of admitting the patient to the hospital, condition clinically deteriorated.  Patient elected to be DNR/DNI while in the ED. Patient was pronounced dead at 10:30 p.m. earlier today.  Preliminary cause of death:  Hypoglycemia induced lactic acidosis.
Around 5 minutes after they administered the second dose of the COVID vaccine, my throat started to feel heavy.  Afterwards, they put an oximeter in my index finger and I think it was a little high (I am not sure). They took me to a separate room and checked my breathing. It got better several minutes later and they gave me 15 mg of Benadryl. Then, the EMT took me to the hospital for observation. At 4:36, they gave me prednisone in the hospital and at 4:49, they gave me famotidine. I was still feeling the tightness in the throat and chest, accompanied with mild pain, but it was better than before. They kept me in the ER for observation until around 7:30 pm.
Edema and erythema reported to pharmacist by patient's wife 9 days after vaccine was administered.
Within half hour of second dose of varicella virus vaccine live, pt experienced stiff neck, headache and nausea. It had been 3 years since her first dose.
At around 11:40am resident was observed to be unresponsive. resident noted with pulse and respiration. Not in any distress. lung sounds clear. Vital Signs BP162/82 P86 R18 T97.1 O2 Sat 96%, fingerstick is 133mg/dl .Resident received COVID 19 vaccine at 11:25am. O2 via 2l NC initiated. Nurse Stat call, 911 initiated, MD at Bedside. Resident awake and responsive. EMT responded and resident left with EMT to be transferred to hospital, remains awake and not in any respiratory distress.
Dtap and MMR given on 7/21/04, Rxn on 7/23/04 with swollen left upper arm, hot to touch. Tx with Benadryl for allergy received 6, 25mg p T4-6 hours. Tylenol 160mg 15ml-9 1/2 tsp every 4-6 hours. Instructed to go to ER if condition worsens.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F), PRODUCT TEMPERATURE EXCURSION ISSUE (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT ADMINISTRATION ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021 at 2:05 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F), PRODUCT TEMPERATURE EXCURSION ISSUE (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT ADMINISTRATION ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F), PRODUCT TEMPERATURE EXCURSION ISSUE (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT ADMINISTRATION ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided No treatment medication were provided   This case was linked to MOD-2021-402935 (E2B Linked Report).; Sender's Comments:  MOD-2021-402935:Master case