chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider(s) recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In MAY 2015, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In JANUARY 2017, the patient was treated by a physician at a medical group office for shingles. The patient was diagnosed with shingles and or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (not specified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Patient was fatigued and resting heart rate was 115-120 on Friday, Aug 13, around 1:30 pm.  Heart rate on Saturday, Aug 14th was 120-160.  Returned to normal on Sunday, Aug 15.
Patient fainted after receiving vaccines. Was on exam table at time of incident it was assisted to supine it immediately regained consciousness vs: HR at 1225 54; HR at 1238 - 80
PATIENT RECIEVED MODERNA 3/12/21 OFF -SITE, P-FIZER GIVEN  04/14/21 ADVERSE REACTION AFTER INJECTION PER OBSERVATION. HEALTH DEPARTMENT NOTIFIED ,SITE LEADER SPOKE TO COVID 19 MANAGER .PATIENTS INFORMATION GIVEN TO HEALTH DEPARTMENT FOR FOLLOW UP.
skin was burning; skin is falling off near the elbow of the left arm; blister; redness from injection site to elbow; covid arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (redness from injection site to elbow), VACCINATION SITE REACTION (covid arm) and BLISTER (blister) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0271321A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness from injection site to elbow) (seriousness criterion medically significant) and VACCINATION SITE REACTION (covid arm) (seriousness criterion medically significant). On 19-Apr-2021, the patient experienced BLISTER (blister) (seriousness criterion medically significant). On 20-Apr-2021, the patient experienced SKIN BURNING SENSATION (skin was burning) and SKIN EXFOLIATION (skin is falling off near the elbow of the left arm). At the time of the report, VACCINATION SITE ERYTHEMA (redness from injection site to elbow), VACCINATION SITE REACTION (covid arm) and BLISTER (blister) outcome was unknown and SKIN BURNING SENSATION (skin was burning) and SKIN EXFOLIATION (skin is falling off near the elbow of the left arm) had not resolved.            No concomitant medications were provided by the reporter.  Patient reported that she  saw her dermatologist. She reported that the blisters were cut open and the dermatologist prescribed Mupirocin 2% ointment.  This case concerns a 60-year-old female with a serious unexpected event of vaccination site reaction, vaccination site erythema, blister, and nonserious unexpected skin burning sensation and skin exfoliation. Event onset 2 days after second dose mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-080031 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Additional event details provided. On 21-Apr-2021: Follow-up contained no new information.; Sender's Comments: This case concerns a 60-year-old female with a serious unexpected event of vaccination site reaction, vaccination site erythema, blister, and nonserious unexpected skin burning sensation and skin exfoliation. Event onset 2 days after second dose mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Headache, chills, sore arm, upset stomach, dizzy, and tired.  Still occurring now, chills have went away, but dizziness fatigue and headache continued. Recommended to continue monitoring symptoms, can use cool wet wash cloth for arm discomfort, and can increase Tylenol dose with the approval of doctor
Rash on legs and arms (fluid filled pustular). Appeared on 7/19/05 per mother.
Three weeks after varicella vaccine she noticed that injection site was painful to touch, was hot and hard. She also had a couple blisters on her neck and scalp. She was diagnosed with a mild case of chickenpox and antibiotics were prescribed for the arm infection.
No symptoms, patient left in stable condition. But dosage was given at an early age, than recommended.
Pt vaccinated with Engerix-B a first dose and no titers developed. A second dose and anti-HBS testing was planned in 30 days Non Responder.
Approximately 1 month after vaccination, I had an underarm rash that spread to arms, neck, back, stomach, legs, feet. It has continued to spread in the last 3 months. I was trying OTC Benadryl that gave no relief. I went to urgent care on 1/27/2022. I was prescribed Cethalexin 500mg for 7 days, Prednisone 20mg for 5 days, and Clotrimadole-Betamethasone cream. The rash never went away. I went to dermatologist on 2/10/2022. I was told to buy sensitive free products and was prescribed Priamcinolone Acetonide Ointment. It had gotten somewhat better but then got worse. I went back to the dermatologists 3/15/2022, I was prescribed steroids for 12 days with not much improvement. I will also add that 11/09/2021, a week after vaccine I was prescribed Clobetasol.
Missed 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and 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.   Concomitant medications were not reported.
I had fever @ aches, sever tiredness the 2-4th day. Day three I noticed sores in my mouth & down my throat. Fever continued along with server tiredness for 3 weeks.  I was put in anti viral & antibiotics on day 8
Patient had received her first covid vaccine dose in the Right  anterior deltoid muscle of her arm, she was observed for her full 15 minutes following protocol. She then complained of feeling flushed tried to elicit for further complaints which the patient responded no. When it appeared safe for her to leave she then left the facility and came back few minutes later complaining of a discomfort while swallowing, tingling sensation to the right arm, rapid heart rate, feeling abdominal pain and sense of nausea. Client was assessed for a (2) ten minutes period for vitals, was assisted to lie flat with legs elevated.
Painful lump on inner aspect of R calf.  Swelling on R lower leg along with diffuse pink skin. Developed 8 days post vaccination. Treated with rivaroxaban started.
Site: Swelling at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: pt appears diaphoretic and flushed. shot given at 9:25 am pt felt effects at 9:28am. Vitals at moment was 96/52, rr - 26, hr- 62 and temp of 96.8. pt asked to seat down, legs elevated, given a bottle of pedialyte (drank about 250ml). bp recheck 15 mins later was 114/73. pt color returned. pt no longer felt tingling and light headed and felt "back to normal." pt stated this had occured in the past during blood draw
immune system was effected and had a flair up of my autoimmune disease; muscle ache mostly on right side of shoulder, muscle ache mostly on right side under breast; horrible shortness of breath; energy level down; Pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (horrible shortness of breath), ASTHENIA (energy level down), PAIN (Pain), CONDITION AGGRAVATED (immune system was effected and had a flair up of my autoimmune disease) and MYALGIA (muscle ache mostly on right side of shoulder, muscle ache mostly on right side under breast) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     Concurrent medical conditions included Lichen sclerosus since 2021 and Collagen-vascular disease since 2021. Concomitant products included VITAMIN B12 NOS, DHEA, 3,3'-DIINDOLYLMETHANE, INDOLE-3-CARBINOL, TOCOPHERYL ACETATE (ESTRODIM), ASTAXANTHIN, LIPASE, DOCOSAHEXAENOIC ACID, EICOSAPENTAENOIC ACID (EPA DHA 720), PREGNENOLONE, IRON, ACETYL-L-CARNITINE, PANTOTHENIC ACID, IODINE (KELP [IODINE]), GAMMA-LINOLENIC ACID, UBIQUINOL, ZINC, MENAQUINONE-7 (VITAMIN K 2), THYROID (ARMOUR THYROID) and VITAMIN D3 for an unknown indication.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced DYSPNOEA (horrible shortness of breath), ASTHENIA (energy level down), PAIN (Pain) and MYALGIA (muscle ache mostly on right side of shoulder, muscle ache mostly on right side under breast). On an unknown date, the patient experienced CONDITION AGGRAVATED (immune system was effected and had a flair up of my autoimmune disease). At the time of the report, DYSPNOEA (horrible shortness of breath), ASTHENIA (energy level down), PAIN (Pain), CONDITION AGGRAVATED (immune system was effected and had a flair up of my autoimmune disease) and MYALGIA (muscle ache mostly on right side of shoulder, muscle ache mostly on right side under breast) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2021, Chest X-ray: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included "Rhodian". Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jul-2021: Follow up received. The new event condition aggravated was added.
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 70 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Feb2021 (Lot number: EN5318) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Enlarged Prostate" (ongoing), notes: onset Date: 4 years ago, Stop Date: ongoing, Pertinent Details: None; "Spinal Surgeries", start date: 2019 (ongoing), notes: Illness/AE: Spinal Surgeries/Disc repair/Fusion, onset Date: (2019), (2017), (2011), Stop Date: Ongoing; "fusion", start date: 2011 (ongoing), notes: Illness/AE: Spinal Surgeries/Disc repair/Fusion, onset Date: (2019), (2017), (2011), Stop Date: Ongoing; "Disc repair", start date: 2017 (ongoing), notes: Illness/AE: Spinal Surgeries/Disc repair/Fusion, onset Date: (2019), (2017), (2011), Stop Date: Ongoing. Concomitant medication(s) included: ASA taken for prophylaxis (ongoing); ALPRULI taken for benign prostatic hyperplasia (ongoing). The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Dec2021, outcome "unknown" and all described as "COVID-19 confirmed by positive COVID-19 test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive.  Follow-up attempts are completed. No further information is expected.
On 4/20/21, at 2:40PM Called clinic & reported numbness of lips and tongue that began on 4/19/21 after second Moderna vaccine. Also reported pain at "5" on 0-10 scale on entire left side of her body. Fever that reached 102 degrees the night of 4/19/21 but reduced to 100 degrees with use of Tylenol and Ibuprofen. States was also having headache at "6" on 0-10 scale. Denied any chest pain or shortness of breath. Reported blood pressure of 102/88 at time of phone call. Patient was directed to go to ER for immediate assessment but she refused. Followed up on 4/21/21 at 11:10AM. She stated headache and fever have resolved. Still has slight numbness of bottom lip and tip of tongue. Appointment with provider scheduled for 4/21/21.
Patient was leaving clinic getting off the elevator.  She felt like her vision was getting dark, developed tunnel vision, and then passed out.
18FEB mom states inc t101, inconsolable crying fever & crying lasted 48+ hrs on 30MAR92; mom states blistering rash across abd & down leg; states ocurred p/DTP & lasted until 30MAR92;
This spontaneous report as received from a physician refers via company representative to a male patient of unknown age. On an unknown date several years ago the patient was vaccinated with ZOSTAVAX vial (strength, lot number and expiry date unknown) single dose subcutaneously for vaccination. Approximately on 30-JAN-2014 (about 3 weeks ago), the patient developed low back pain and received unspecified steroid injection and muscle relaxants as treatment initially. On 31-JAN-2014 (next day), the patient called the office to report the development of a rash on his lower back. The patient was diagnosed with shingles and was prescribed acyclovir (manufacturer unknown) and NEURONTIN. On an unknown date the patient experienced postherpetic neuralgia. No laboratory test was performed. The outcome of low back pain, postherpetic neuralgia and shingles was reported as not recovered/not resolved. No further information provided. Additional information has been requested.
Instantaneous burning sensation in eyes. I have since developed an allergy to the chemical wipes I have Been using for the last 16 years at work.
The pt experienced left upper arm pain with numbness and tingling. The left hand and 4th and 5th digits had numbness and tingling. The symptoms started suddenly 10-15 minutes post vax.
cough, body aches, congestion, chills, shortness of breath. starting 1/1/2022
Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: rhinorrhea-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Additional Details: also taste changes
58 Y female with PMH of Graves Disease s/p thymectomy via median sternotomy (12/2012) on pyridostigmine, generalized anxiety disorder, and hx of frequent hospitalizations for myasthenia gravis flare ups transferred to the ICU on 8/5/2022 for myasthenia crisis. Patient states that she felt typical symptoms of her myasthenia crisis (weakness in her extremities, shortness of breath, and severe pain behind her left eye + blurry vision/diploplia) 40 minutes after receiving the Moderna vaccine this morning.   Per chart review, she has a recent history of hospitalization for myasthenia crisis s/p 3rd dose of Covid vaccine from 12/1/21 - 12/5/21 and other recent hospitalizations for regular flare ups from March 2022 and June 2022. The plan on discharge after her Covid induced flare up was to follow up with neurology prior to her next shot.   Compared to her previous flare up after a covid vaccine, she states that this episode has a quicker onset and she has less shortness of breath. Of note, she has been unable to take her PTA mestinon for the past 10 days after running out of her medications.   Endorses HA, eye pain Denies SOB, abd pain, chest pain, chills, nausea, vomiting, dysuria. Other ROS are negative unless otherwise stated in the HPI. Pt's NIF improved to -40 by next day with BLE weakness resolved and was stable to be transferred to the floors. Pt still had some residual L eye ptosis and pain, but no longer had any diplopia. Next day, pt's L eye ptosis has resolved completely, but she continued to have L eye pain. Pt initially was on: acetaminophen, PTA tramadol 50mg q6h, dialudid 0.2mg q4h PRN. However, pt's pain was still not controlled when dilaudid 0.2mg was changed to Oxy 5mg q4h PRN for longer effect and scheduled Tramadol 100mg q8h and Acetaminophen 1000mg q8h. If her pain continues, she can f/u with her Neurologist/Ophthalmologist. She received IVIG for 3days and will completed the remaining 2days tx at outpt infusion center. Pt passed the road test without any difficulty and is stable for d/c home.  Reason for Hospital Admission (Admitting Diagnosis):  Myasthenia Gravis flare up
Severe fatigue; Intermittent fever as high as 102 F; Chills; Muscle aches; This is a spontaneous report from a contactable healthcare professional. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E W0173) via an unspecified route of administration in the right arm on 26Jul2021 at 16:15 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On 27Jul2021 at 04:00, the patient experienced severe fatigue, intermittent fever as high as 102 F, chills and muscle aches still occurring from 12 hours post vaccination (lasting 3 days so far). The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. On 27Jul2021 at 04:00, the patient underwent lab test and procedure which included body temperature and the result was shown as 102 F. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe fatigue, intermittent fever as high as 102 F, chills and muscle aches were not resolved at the time of this report.
pt recv vax & devel fever w/chills & shaking, sore throat & dizziness which persisted 7 wk post vax;
04/14/2021- I could not move my arm, I could not lift my left arm. I could not brush my hair. On 4/15/2021- I had an appointment with my doctor for my fibromyalgia and I explained to my doctor that I was having problems with my left arm. The doctor examined my left arm with a machine that is like a sonogram. He diagnosed it as bursitis  07/08/2021- the doctor gave me an injection because my arm was so sore and I was not able to lift my left arm and move it. They prescribed 6 physical therapy sessions. The doctor thinks it was the administration of the injection.   I have not recovered from my adverse event. Now I feel like I have neuropathy in my left arm. My arm falls asleep. My fingers feel like they are inflamed, but they are not swollen. It is a sensation.  It is a sensation of pain and like my arm is asleep. I feel like I am having a cramp. I have a difficult time holding objects with my left arm. I cannot lift my arm to brush my hair or put on deodorant and daily activities.
Saturday my daughter woke up extremely hyper. She could not seem to control her behavior. She did not make eye contact with me but instead would look past me. She could not sit down and she was running, skipping, galloping almost non stop. We couldn't even get her to sit still to eat. She seemed to have uncontrollable tics putting her finger in her nose over and over (something she did not do prior). She also kept licking things over and over and would touch things and lick her finger over and over seemingly with no control. Saturday night, she woke up around 1:30 am crying. She kept telling us she could not close her eyes, but they were closed. She was very panicky. She was unable to self soothe. She had some arm and leg movements that appeared to be involuntary.  She cried and yelled about hair touching her arm and then could not warm up no matter how many blanket we put on her. When we tried to put the t.v on to calm her she began yelling it's too bright. The crying and panicking went on until approximately 3:30 am. Sunday she woke up hyper and it was a repeat of Saturday. Sunday night she woke up and did basically the same thing she did the night before but it was slightly less severe. Monday, she was calmer but still slightly hyper and still continued with the licking and behaviors such as putting her finger in her nose. When I correct her she usually just looks at me with a blank stare. Its not like her at all. She is still not 100% herself. She is still doing some of the odd behavior but not as often. We are looking into hyper baric chamber therapy and some detox regimens. No treatment has been given so far.
Pt recvd 1 dose of Engerix-B & devel a fever which was self-treated;
Client was administered the vaccine while symptomatic (01/25/21) although client did not know he was symptomatic for COVID-19. He had been exposed to a family member who had tested positive and should have been in quarantine but wasn't either because it was not felt he was considered a close contact  by his family opinion or his family member never notified public health of this close contact...?. Clinet had presented to the ED following day after vaccination for shortness of breath and fatigue and an antigen test showed he was positive for COVID-19. He was sent home that same day 01/26/21. He was back in ED on 01/28/21 for worsening symptoms and admitted to hospital and later placed on ventilator. He passed away on 02/09/2021 (date of death was per his wife).
12 hours after 1st dose of Rabavert, became very emotional and was crying hysterically for about 10 minutes. 2 hours after 2nd dose of Rabavert had difficulty communicating and concentrating and was hyperactive. She reports: Felt hot, temp not taken. Symptoms lasted about 2 hours.