chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain in the back/when moving the back it hurts; feet and hands were sweaty; little bit of a headache; muscle aches; feel tired, like without desire; strong stomachaches; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (strong stomachaches), BACK PAIN (pain in the back/when moving the back it hurts), HYPERHIDROSIS (feet and hands were sweaty), HEADACHE (little bit of a headache) and MYALGIA (muscle aches) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (strong stomachaches). On an unknown date, the patient experienced BACK PAIN (pain in the back/when moving the back it hurts), HYPERHIDROSIS (feet and hands were sweaty), HEADACHE (little bit of a headache), MYALGIA (muscle aches) and FATIGUE (feel tired, like without desire). At the time of the report, ABDOMINAL PAIN UPPER (strong stomachaches) had not resolved, BACK PAIN (pain in the back/when moving the back it hurts) was resolving and HYPERHIDROSIS (feet and hands were sweaty), HEADACHE (little bit of a headache), MYALGIA (muscle aches) and FATIGUE (feel tired, like without desire) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant drugs includes Blood pressure medications. The treatment includes 3 Tylenol 350 mg each one in a different day.   Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2021: date, Date of birth, Event was updated. On 05-Jul-2021: No new information
Sleeping 12 hours per night plus a daily nap for approximately 8 days (usually sleep 7-8 hours per night)
Patient was in store for 15 minute monitoring after dose, he states he was anxious and pacing back and forth then he felt faint/dizzy and fell over in the store.  Pharmacist and staff ran over to help patient and called 911, initially had him sit up on the floor after 2-3 minutes he was comfortable enough to sit in a chair.  Patient was given water he stated he still felt a little dizzy and was very anxious stated his arm hurt from falling down.
None Reported Narrative: A 71yo male who had hospitalization for Aspiration Pneumonia and Sepsis from 12/13/20 to 12/18/20 and with clinical decline since hospitalization. Per December 22, 2020 Physician's documentation, the patient was transferred back to facility with poor functional status including difficulty swallowing. It was also documented he had progressive underlining medical conditions of Multiple Sclerosis, Decubitus Ulcer with possible Osteomyelitis and Hypertension related complications with poor medical prognosis. He received a Covid-19 vaccine on December 21, 2020 with no documentation of any vaccine related ADR December 22, 2020 Nurse Progress Note included patient had generalized weakness although calm and somewhat relaxed. Nurse's documentation included the patient had watery/loose stool in AM, had Tachypnea and a but gurgly with fever. Suctioning was non productive, desating @ 91 -91% and O2 was initiated on 2L nasal cannula improved to 94%, was given Tylenol and temp improved to 98.8 from 99.3. He was on G-tube feeding and it is documented he passed away on January 1, 2021 while in hospice PMH - Hyperlipidemia, Chronic Hepatitis, Blindness in both eyes, Chronic Pain, Neurogenic Bladder, Mood Disorder due to general medical condition, Neuromyelitis Optica, Dysphagia oropharyngeal stage, DM, Transverse Myelitis, Quadriplegia and Neurogenic Bladder, Neurogenic Bowel, Multiple Sclerosis, Pressure Ulcer of Sacral Region, Moderate Cognitive Impairment, Hx Peripheral Vascular Disease, HTN, Acute Kidney injury
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown gender and age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about an unknown date in 2015, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On or about later in 2015, the patient was treated by a healthcare provider for shingles. As a further proximate result, the patient had suffered and would continue to suffer significant medical expenses, and pain and suffering, and other medical related expenses which includes 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; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. Causality assessment was related.
developed numbness and tingling over body; pins and needles over all skin areas; numbness of legs, feet,torso; admitted to the Hospital; still have residual numbness and tingling
Second vaccin19 days from first vaccinee schedule; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second vaccin19 days from first vaccinee schedule) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second vaccin19 days from first vaccinee schedule). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second vaccin19 days from first vaccinee schedule) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Mother reports fever of 104.0 F 4 days after immunization requiring a visit to the ER where workup was negative for any illness.
Patient reported hives around the navel, thigh and arm pits.  The rash then grew to legs and feet.
Systemic: Fainting/Unresponsive-Severe, Systemic: Hypotension-Medium.
Information has been received from a nurse concerning a patient who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine.  Subsequently the patient developed an allergic like reaction post vaccination.  The reaction included a swollen, large red area about six inches in diameter around the injection site.  The patient sought unspecified medical attention.  At the time of this report, the outcome was unknown.  Additional information has been requested.
Per pt she experienced nausea with vomiting, weakness, dizziness, pain in her abdomen, arms, neck, and back. Pt offered an appointment to come to the office but declined.
Pain in upper arm, headache, fever (100.1), chills, tiredness (effects lasted for approximately 36 hours after onset)
Readmitted with new Left temporal lobe infarct (new stroke) after an unwitnessed fall at Skilled Care Facility
Sore arm; Exhaustion; A spontaneous report was received from a consumer concerning a 73-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, exhaustion.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 015M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 22 Feb 2021, the patient experienced the event(s) sore arm, exhaustion.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sore arm, exhaustion was unknown.
Fever 102, respiratory congestion, wheezing, skin blotchy redness around eyes and hands, severe fatigue, joint pain. Called PMD, observed at home. Ibuprofen 200 mg every 4-6 hours, symptoms 2 weeks. Fever gone 3 days.
Immediate numbness of arm/hand. Burning pain, sweating, freezing  and cotton mouth feeling within 10 minutes of injection    Injection site was at top of humerus bone area
Headache, Arthralgia, Diarrhea, fatigue Narrative:  Other Relevant History:
Pt presented to office for PPD reading and parents noted a "swollen knee". Pt had non-erythematous edema at (L) thigh from injection site upper/lateral thigh down to knee with mild tenderness without warmth. Advised to give ibuprofen & apply ice.
Had both my vaccinations, now getting over shingles/suspected vaccination failure; Getting over having shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with antibiotics nos. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had both his/her vaccinations and just now getting over having shingles. The patient was still taking antibiotics for it. The patient stated that was not a real bad case of it, but it was still. Additional supportive information: This case was considered as suspected vaccination failure as details regarding the time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible, as no contact, details were available.
1.5 cm rash (R) thigh at injection site with one pustule approximately 1 mm.
Sedation shortness of breath Narrative:  Patient presented for second COVID vaccine. After receiving  vaccine, reported "some shortness of breath and feeling sleepy. Denied rash, itching, cough, chest pain, or throat swelling. Was given 50mg IM  diphenhydramine and transported to ED. Endorsed similar reaction to first dose however symptoms resolved within 1 hour. IV famotidine 20mg and PO  acetaminophen 650mg given in ED. Patient slept in ED and woke feeling better, reporting complete resolution of symptoms. Was discharged home with outpatient  prescriptions for diphenhydramine and cetirizine.  Other Relevant History:
Started with lower back pain in the morning when I woke up. Then my back and hamstring muscles tighten up. All that went away as the day went on. Just a lingering discomfort remained.  That night I was awaken by 10/10 dull pain in both my hips. I don?t have arthritis, but I imagine that is what the pain must feel like. That eventually subsided over the course of the night and then the following morning I woke up with a stronger lower back pain and major stiffness in my hamstrings, but the hip pain was gone. Throughout the day the pain would come and go and move up and down my back and along my spine. It was the strongest on the night of the 22 and has since gotten weaker and the tightens in my back and hamstrings has since left. Now I just get random aches throughout my back that come and go during the day. Yesterday, the 27th, I was hiking down a hill and the impact from that caused instant discomfort in my spine, it felt like it was compressing like an accordion. Never had this happen before. After that my back was sore for hours. Today, the 28th, I tried jogging and the spinal discomfort was instantly there. Went about thirty yards before I stopped and my back has been aching down my spine for hours.    Also been experiencing a couple mild headaches through the day since the 22nd.  This also has fired up the endothelial dysfunction in my heart which causes some strong chest pain throughout the day. I?ve gone back in my heart medication, so hopefully that will fix that issue. I will be contacting my cardiologist in regards to this and seeing if the vaccine can affect that.
felt like he fell in a big tub of ice; after 2nd dose, chills for 5-10 minutes/chills came out of "nowhere," went away fast; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (felt like he fell in a big tub of ice) and CHILLS (after 2nd dose, chills for 5-10 minutes/chills came out of "nowhere," went away fast) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 025L20A) for COVID-19 vaccination.     Concomitant products included ATENOLOL and FENOFIBRATE for Blood pressure high.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced FEELING COLD (felt like he fell in a big tub of ice) and CHILLS (after 2nd dose, chills for 5-10 minutes/chills came out of "nowhere," went away fast). At the time of the report, FEELING COLD (felt like he fell in a big tub of ice) outcome was unknown and CHILLS (after 2nd dose, chills for 5-10 minutes/chills came out of "nowhere," went away fast) had resolved.            Treatment information was not provided.  Patient contracted COVID 2 weeks ago but he is doing great and fine. Patient received second dose on a Saturday morning and he had chills on Tuesday at 7 pm for 5-10 minutes.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
10 x 8 cm area of erythema to (L) bicep & 1-2 cm area of  -> & warmth over injection site.
Tingly feeling of the face and nausea for 2 hrs after the injection, next morning I felt headache, tiredness, muscle and joint pain, chills, brain fog, inability to do normal functions  this lasted for 2 days, however the brain fog and headache continued for another day after that. the joint pain has continued still I have it.
Mild swelling of lips, tongue and throat given 25mg of benedryl resolved within an hour
the second shot, I experienced pain on my right arm and it kind of when away a few days and it comes back and at times the pain is extreme that I have difficulties moving my arm
Headache, arm discomfort, then pain, redness and severe swelling, then got very hard. Extremely tired, joints ached. Fast heart beat, chills, extremely weak, fuzzy headed, and slurred language. Pain so bad, woke me at night. Slept alot, even during the day. Couldn't think straight or focus on anything, too tired.
Patient alert and oriented. Around 3:02pm got vaccinated with 1st dose of Moderna vaccine on the left deltoid. At 3:04pm, patient experienced lightheadedness, dizziness and x1 episode of vomiting. VS#1 130/90, 95%, 90 and 16. Per patient she is driving herself at home. Denies any dizziness, and lightheadedness.   At 3:28p, patient experienced another episode of vomiting, lightheadedness and dizziness. VS#2 96%, 88, 16, 130/90. Husband arrived to pick up the patient. Patient is alert and oriented. Denies dizziness, lightheadness and nausea & vomiting. With steady gait. No s/sx of distress. Go home safely.
5 days post vax pt exp illness & severe joint pain lasting x 3 days-12 days post vax rash, swollen glands;
p/vax pt exp prolonged sleepiness; regression of milestones; & dec activity w/inc fussiness for 2wk;
- first time pregnancy with a male fetus - expected to deliver on April 8, 2022 - symptoms: besides the typical pain at injection site, fever, and fatigue, I experienced a new symptom with the booster, which was bad lower abdominal pain. After experiencing bad lower abdominal pain for 13 hours straight, I decided to visit the ER. They gave me tylenol pills, and I took them. But the pain continued well into the next day, though at a lower frequency. But when the pain hit, the level of pain was the same. I felt better on the 3rd day, and the pain was gone by the 4th day.
Case previously recorded as MA2009-3758. Initial case report received from a registered nurse on 10 NOV 2009. A 56-year-old female patient was vaccinated with S-OIV FLUVIRIN (batch no. 101716P1A) i.m. into the left deltoid on 26 OCT 2009. The patient woke up feeling dizzy 48 to 72 hours after vaccination. She also had nausea, headache and malaise. The symptoms resolved after 12 to 16 hours.
patient called the pharmacy and mentioned she has been experiencing dizziness for a couple of weeks. She also mentioned that she had vertigo and is not sure if the cause is the vaccine or the vertigo.
I started breaking out in a rash on my upper right chest. It continued to go into my neck area on the right side. I was diagnosed with Shingles and was prescribed hydrocortisone cream. Two weeks later I continued to have an itch on my arm and upper chest, it felt like an allergic reaction, I went to see my doctor and was prescribed an oral steroid to help. I still continue to get a itch on small areas of my body.
Patient went to employee health for the development of rash that occurred after being administered the ZOSTAVAX Vaccine. He was treated with a 5 day course of Prednisone.
Treatment of COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and on 21Mar2022 as dose 2, single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient's relevant medical history included: "Raynauds Syndrome (circulation deficiency)" (unspecified if ongoing), notes: circulation deficiency; "B12 deficient" (unspecified if ongoing); "facial paralysis/concussion" (unspecified if ongoing); "facial paralysis/concussion" (unspecified if ongoing); "Known allergies: Gluten allergies" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Treatment of COVID-19"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19. The clinical course reported as 4 hours after taking 1st dose, awful nausea occurred. Restless legs and couldn't stop shaking. Diarrhea once as well and adverse event start date: 11May2022. The patient did not received other medication in 2weeks. The patient received COVID 19 Treatment, brand: Paxlovid, treatment start date/ stop date: 11May2022 and indication: treatment of COVID-19 administrator route: oral. The patient Known allergies: Gluten allergies. The patient Other medical history: Raynauds Syndrome (circulation deficiency), B12 deficient, facial paralysis/concussion  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Allergic reaction; More dense Saliva; Headaches; Nauseous; Cold; Discomfort in the body; Not able to eat; Vomit 2 times; Blood pressure high; Pain in the joints; Pain in the neck; Red face; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction), SALIVA ALTERED (More dense Saliva), HEADACHE (Headaches), NAUSEA (Nauseous) and NASOPHARYNGITIS (Cold) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Pre-diabetes and Hyperlipidemia (high cholesterol.). Concomitant products included ATORVASTATIN for High cholesterol, METOPROLOL and AMLODIPINE for Hypertension, VITAMIN D2, UBIDECARENONE (Q10) and IRBESARTAN for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction), SALIVA ALTERED (More dense Saliva), HEADACHE (Headaches), NAUSEA (Nauseous), NASOPHARYNGITIS (Cold), DISCOMFORT (Discomfort in the body), EATING DISORDER (Not able to eat), VOMITING (Vomit 2 times), HYPERTENSION (Blood pressure high), ARTHRALGIA (Pain in the joints), NECK PAIN (Pain in the neck) and ERYTHEMA (Red face). The patient was treated with DICLOFENAC for Adverse event, at an unspecified dose and frequency. On 03-Mar-2021, HYPERSENSITIVITY (Allergic reaction), SALIVA ALTERED (More dense Saliva), HEADACHE (Headaches), NAUSEA (Nauseous), NASOPHARYNGITIS (Cold), DISCOMFORT (Discomfort in the body), EATING DISORDER (Not able to eat), VOMITING (Vomit 2 times), HYPERTENSION (Blood pressure high) and ERYTHEMA (Red face) had resolved. At the time of the report, ARTHRALGIA (Pain in the joints) and NECK PAIN (Pain in the neck) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Blood pressure measurement: high (High) 180-107-93.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Narrative: COVID infection after completion of COVID vaccine series: 01/26/2021 COVID vaccine dose #1 02/17/2021 COVID vaccine dose#2 07/09/2021 Pt presented to front of VA c/o fatigue and loss of taste/smell. Stated wife had dx of COVID on 07/07/2021 and admitted to facility for tx. 07/09/2021 COVID positive per nasopharyngeal swab (as ordered based on COVID positive screening tool). 07/10/2021 Pt reported continued feelings of fatigue. 07/11/2021 Pt reported continued feelings of fatigue. 07/12/2021 Pt reported resolution of symptoms.
Acute vertigo starting on 10/9/2021. Started to have new chest pain/dyspnea along with the vertigo.  New frequent PVCs noted along with bigeminy. Echo with preserved EF and mild LVDD. BNP 316, hsCRP >10.0, hdTnT < 6. Needed to see ENT and had head CT scan. Meclizine was helping.  Nuclear Stress testing showed no ischemia.
Patient reports 103F, vomiting and increased heart rate. Patient also states that they got the Pneumoccocal vaccine within previous 3 weeks of getting the influenza vaccine.
Signs and symptoms: SOB, Cough. Treatment:  remdesivir and IV dexamethasone 6 mg
Client came into clinic 11/10/2003 with complaint of soreness and bruising.  ON exam found soreness consistent with expected side effects.  Bruise noted right deltoid approximately 1 1.2 inch in diameter.
erythema multiforme rash, progressed over 72 hours and then disappeared after 72 hours.
Began with numbness in lower left arm, tingly left side of face, dizziness with blurred vision.  I had severe migrane headaches that evening at the hospital.  I was completely fine before the shot.  I have never had migrane headaches before.  I underwent several tests to find a reason and none of the findings could explain why I was having these symptoms. The medical record received on 12/23/03 states lightheadedness. The medical record received on 3/23/04 states photophobia and nausea.