chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Several days after 2nd injection, I started feeling dizzy.   Unstable/uncomfortable feeling continued.  Thought it was vertigo, and went to ENT Doctor, and he/I thought it was BPPV (ear crystals).   Did mechanical exercises and went home.   Unstable, cloudy, brain fog feeling, difficult reading/concentration continued.    Went back to ENT on 6/11.    He asked additional questions (confirmed that my dizziness feeling was Not "spinning sensation", and thus not BPPV/ear crystals).   He asked when I got my vaccine.  Given close proximity to onset of symptoms, that it could be a neurological response to the vaccine via inflammation of the brain.  He suggested a steroid shot, and after several days post the steriod, I started feeling better.    Conclusion:   For approx 5+ weeks post the 2nd vaccine shot, I was very uncomfortable/unstable and can best describe as serious "brain fog", which I have never previously had.
Shoulder is very sore with limited range of motion.  The shot was given high just below the bone.  felt the pain immediately.
Shaking, upper extremities could not be controlled, jaw clenched, neck rigid, very cold and could not warm up even when standing in a hot shower, the very cold  I do not have the information concerning the lot number of the vaccine
no additional adverse effect reported; VARlVAX that underwent a temperature excursion was administered.; This spontaneous report was received from a nurse and refers to a patient of unspecified demographics. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 22-FEB-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # T022315, expiration date 30-JUN-2022 (exact dose, route of administration and anatomical location were not reported). Administered dose of vaccine experienced the temperature excursion between -10 degrees Celsius to 8 degrees Celsius (-3.7 degrees Celsius) for 22 hours. Data logger was involved. There were no previous excursions reported. There was no adverse event reported.
Started to itch really bad after the shot and severe pain increased as the day went on, that night there was a huge red lump the size of a golf ball felt size and had body aches and have extreme fatigue, each day the lump and redness has increased to now the size of a salad plate, pain and itching has increased as well, even with cold compress, taking ibuff, Tylenol and antihistamines.
Arrived at hospital ER at 1:59AM pulseless, in asystole.
1-5: fever, chills, aches,fatigue. Started tylenol/ibuprofen 1-6: facial and throat swelling, continued side effects. Started benadryl.  Continued through 1-7 with some improvement in swelling and general side effects. 1-8: swelling and numbness with droop to left eye and numbness to lips.  IC visit. Received steroid injection and started pepcid and allegra in addition to benadryl.  1-9:  swelling and most general side effects resolved. Left eye numbness/droop and numb lips still present. 1-10 : Droop resolved, numbness remained.  1-12: Numbness resolved.
I started a little dizzy after the vaccine but could have been my cycle. Later that evening my arm was soar and swollen. I didn't take anything, a little difficult to sleep. The next day it started wearing off, I did ice the area.
This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of hives on side of body in a 13-year-old female subject who was vaccinated with HAVRIX, (GlaxoSmithKline).  On 11 August 2010 the subject received 1st dose of HAVRIX (unknown route, left arm).  On 11 August 2010, less than one day after vaccination with HAVRIX, the subject experienced hives on left side of body.  The event was considered clinically significant (or requiring intervention).  The subject was treated with Benadryl.  At the time of reporting the event was improved.  The healthcare professional considered the event was probably related to vaccination with HAVRIX.  The GSK representative stated that the event was clinically significant because "the doctor had to give the subject Benadryl to try to stop her the reaction".  Follow-up information received on 13 September 2010 indicated that the subject experienced an allergic reaction to HAVRIX on 11 August 2010 developing hives on the side of her body.  The outcome of the events was unknown and the physician felt the events were probably related to HAVRIX.  Further treatment with HAVRIX was discontinued.  It was noted that the subject has not experienced any adverse reactions to previous vaccinations.
Intense dizziness, brief loss of consciousness the next morning. The intense dizziness lasted about 25 minutes, including a brief period of unconsciousness. It resolved after that without intervention. Other concurrent events were fever, chills (beginning midnight after the shot), weakness, muscle aches.
Acute onset of pain in neck, shoulder within 24 hrs of booster dose, responded to steroids, but symptoms returned when weaned off in about 2-3 wks. ESR, CRP high both 1st time. ESR 12/21 26, 2/22 58. CRP 12/21 2.3, 2/22 2.2. After 2/22 Resumed steroids again
Had flu shot on 10-11-10 - On 10-13-10 about 10 p.m. started developing hives - hands - feet swelling. Called on call Dr. Started on CLARITIN - Mom used Suave skin lotion .
Brain fog; Swelling of Lips; Headache; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), FEELING ABNORMAL (Brain fog), LIP SWELLING (Swelling of Lips) and HEADACHE (Headache) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore Arm). On 28-Jun-2021, the patient experienced FEELING ABNORMAL (Brain fog), LIP SWELLING (Swelling of Lips) and HEADACHE (Headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Sore Arm), FEELING ABNORMAL (Brain fog), LIP SWELLING (Swelling of Lips) and HEADACHE (Headache) outcome was unknown.            This case was linked to MOD-2021-238986 (Patient Link).
Patient admitted 5/8/21 with bilateral P. E -Spontaneous, went to Hospital 9 days post vaccine #2.  I did not give the vaccine, it was done at a vaccine clinic.  Unknown if related to vaccine but within 2 weeks.
Initial misuse report received from a nurse on 02-Oct-2013: The 11-months-old patient received FLUZONE 0.5 ml. No adverse event was reported. Lists of documents held by sender: none.
Felt like she had the flu but ten times worse; Diarrhea; Vomiting; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like she had the flu but ten times worse), DIARRHOEA (Diarrhea) and VOMITING (Vomiting) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Celiac disease, Fibromyalgia and Hashimoto's disease. Concomitant products included DULOXETINE, CELECOXIB (CELEBREX) and GABAPENTIN for an unknown indication.   On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced DIARRHOEA (Diarrhea) and VOMITING (Vomiting). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Felt like she had the flu but ten times worse). At the time of the report, INFLUENZA LIKE ILLNESS (Felt like she had the flu but ten times worse), DIARRHOEA (Diarrhea) and VOMITING (Vomiting) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Treatment information was not provided.
T98 110/78 P76. On 5/18/06 3:15P states vomited last night at 9:00PM following immunizations that day between 1:00P (hep A, Typhim Vi, Ipol, JE VAX) at 3:00P. Vomited several times until midnight. Denies diarrhea, no abdominal pain, no HA, L.S clear, abd nontender x 4 quad. No diarrhea. Taking liquids and food s difficulty.
Tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATENOLOL for an unknown indication.   On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced FATIGUE (Tired). At the time of the report, FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Blood pressure measurement: 112/72 mmHg (Low) Unknown. On 16-Mar-2021, Heart rate: 115 (High) Normally between 77 and 80 (74 when resting)..         Treatment information was not provided  Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
I started thinking the vaccine went to my skin and now it is not effective; Arm was all red all the way down almost to my elbow, very long part of my arm, it was very red; It was very long part of my arm, was very red and swollen; The 1 inch needle goes into my skin and not my muscle; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Arm was all red all the way down almost to my elbow, very long part of my arm, it was very red), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (The 1 inch needle goes into my skin and not my muscle), PERIPHERAL SWELLING (It was very long part of my arm, was very red and swollen) and VACCINATION FAILURE (I started thinking the vaccine went to my skin and now it is not effective) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 11-Feb-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (The 1 inch needle goes into my skin and not my muscle). On 12-Feb-2021, the patient experienced ERYTHEMA (Arm was all red all the way down almost to my elbow, very long part of my arm, it was very red) and PERIPHERAL SWELLING (It was very long part of my arm, was very red and swollen). 12-Feb-2021, the patient experienced VACCINATION FAILURE (I started thinking the vaccine went to my skin and now it is not effective). On 11-Feb-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (The 1 inch needle goes into my skin and not my muscle) had resolved. At the time of the report, ERYTHEMA (Arm was all red all the way down almost to my elbow, very long part of my arm, it was very red), PERIPHERAL SWELLING (It was very long part of my arm, was very red and swollen) and VACCINATION FAILURE (I started thinking the vaccine went to my skin and now it is not effective) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was unknown. Treatment information was not provided.; 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 (vaccination site erythema and vaccination site swelling) a causal relationship cannot be excluded. Based on the information reported, the second dose was still pending, so the event (vaccination failure) is assessed as unlikely related to mRNA-1273. This report refers to a case of underdose, and device connection team for mRNA-1273, lot # 041L20A with no associated AEs.
pt recv vax; monoplegia lt leg;febrile illness;not weight bearing leg;curling of lt toes;sedimentation rate sl elev;leg flaccid;no deep tendon reflexes noted;platelet screen 373,000;hypertonic;ulnar palsy;SGOT 40;SGPT 48;CSF 3WBCs;41 RBCs;
Narrative: Date of Admission: 04/25/21 Date of Discharge: 5/5/21 Admission Diagnoses: 1. Generalized weakness and fatigue 2. Multiple falls 3. Lower extremity weakness 4. Asthma 5. HTN Discharge Diagnoses: 1. Multiple falls 2. Generalized weakness and fatigue 3. Near syncopal episode 4. Asthma 5. HTN Brief History and Hospital Course: 80 yr old male, presented with generalized weakness, fatigue and multiple falls, was seen by Physical Therapy, condition stabilized, discharged to SNF. Advised to followup with his PCP within one week. HPI: patient presented to ER w/ c/o multiple falls, weakness and lack of coordination. Told ER he had gotten COVID vaccine last month and his issues may have started then. CT head and MRI brain showed not acute abnormalities. Patient has known hx of PMR and vestibular dysfunction. Reports he also has new RUE tremor that started after COVID vaccine. Neuro evaluated patient and started trial of sinemet. Also found to have urinary retention and UTI and had foley placed and started on course of antibiotics. Sent to SNF for further therapy and medical management.
I received the Tdap vaccine on 8/15/2019 and on 8/18/2019, I could not physically move my right arm over my head or abduct my right arm from my body. It was 7/10 pain to move my arm and this lasted for 2.5 months. I then sought treatment during my Hospital Orientation. I completed 4 weeks of Physical Therapy. I am able to move my arm more freely but it is still often painful.
Fever of 102, body aches, chills, nausea, fatigue Lasted 24 hours
Reaction to COVID vaccine; Drug does not help joint pain; Sore arm; Connected tissue disease; Nauseous; Vomitting; Joint pain; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Reaction to COVID vaccine), DRUG INEFFECTIVE (Drug does not help joint pain), PAIN IN EXTREMITY (Sore arm), CONNECTIVE TISSUE DISORDER (Connected tissue disease) and NAUSEA (Nauseous) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction to COVID vaccine), DRUG INEFFECTIVE (Drug does not help joint pain), PAIN IN EXTREMITY (Sore arm), CONNECTIVE TISSUE DISORDER (Connected tissue disease), NAUSEA (Nauseous), VOMITING (Vomitting) and ARTHRALGIA (Joint pain). At the time of the report, VACCINATION COMPLICATION (Reaction to COVID vaccine), NAUSEA (Nauseous) and VOMITING (Vomitting) had resolved, DRUG INEFFECTIVE (Drug does not help joint pain) and PAIN IN EXTREMITY (Sore arm) outcome was unknown and CONNECTIVE TISSUE DISORDER (Connected tissue disease) and ARTHRALGIA (Joint pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION COMPLICATION (Reaction to COVID vaccine), PAIN IN EXTREMITY (Sore arm), NAUSEA (Nauseous) and VOMITING (Vomitting) to be probably related. No further causality assessments were provided for DRUG INEFFECTIVE (Drug does not help joint pain), CONNECTIVE TISSUE DISORDER (Connected tissue disease) and ARTHRALGIA (Joint pain).    No treatment information provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event of vaccination complication, pain in extremity, connective tissue disorder and nausea, a causal relationship cannot be excluded, humira was also a confounder. Causality for the event of drug ineffective is not applicable.
At 3:30 pm (2 hours after the injection) my arm at the injection site started to hurt and I felt light-headed and had chills,  These symptoms continued, plus I became exhausted and my joints hurt.  My stomach was queasy.  By the next morning, my joints hurt so much it was difficult to roll over in bed, and all the other symptoms were still there and worse.  I did not have a fever.  I developed a headache.  All I could do was lie in bed; sitting up felt exhausting.  By evening of that day, my joint pain was lessening and my stomach felt somewhat better.  By the following morning, I felt normal, basically.  So in total, about a day and a half of bad reaction.
He had significantly larger than normal redness, swelling, and heat around injection site; He had significantly larger than normal redness, swelling, and heat around injection site; He had significantly larger than normal redness, swelling, and heat around injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (004756). The reporter is the parent.  A 3-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 31May2022 as dose 5, single (Lot number: FJ2602) at the age of 2 years, in left thigh for immunisation; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), on 31May2022 as 3.7 ml (Batch/Lot number: unknown). The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: prevnar 13 (Dose 1: Prevnar 13, Lot# :AF5647, left thigh), administration date: 29Jul2019, for Immunization; prevnar 13 (Dose 2:Prevnar 13 , Lot# : AF5647, left thigh), administration date: 07Oct2019, for Immunization; prevnar 13 (Dose 3: Prevnar 13, Lot# : AG8356, left thigh), administration date: 19Dec2019, for Immunization; prevnar 13 (Dose 4: Prevnar 13, Lot# : CY4766, left thigh), administration date: 21Sep2020, for Immunization. The following information was reported: INJECTION SITE ERYTHEMA (non-serious), INJECTION SITE SWELLING (non-serious), INJECTION SITE WARMTH (non-serious) all with onset 31May2022, outcome "unknown" and all described as "He had significantly larger than normal redness, swelling, and heat around injection site". Therapeutic measures were taken as a result of injection site erythema, injection site swelling, injection site warmth.  Additional Information: Caller states she is actually the parent of the three year old who was given Prevnar 20 at his pediatrician's office and she works in the medical field, states at the doctors office at the time of the vaccination a vaccine handout was not provided to her at the time, during the visit she remembered being told at the provider's office that the patient was due for Prevnar, the new updated shot, states that sentence stuck with her. Patient received the Prevnar 20 vaccine in his left thigh, states he had significantly larger than normal redness, swelling, and heat around injection site, states it was not serious but definitely more than normal, states he did not have a fever, but that the patient was tired and irritable afterwards, caller states she treated the patient with Tylenol on Tuesday evening and Wednesday evening after the vaccine. Caller states the child did take 3.7mL of children's Zyrtec morning 31May2022, the day of the vaccine.  No follow-up attempts are possible. No further information is expected.
Muscle soreness in R arm, started approx. 24 hours post vaccination, continued x3 weeks. Reports taking OTC ibuprofen with positive effect.
Received Adacel inj at Clinic day prior to developing 103 deg fever.
This spontaneous report as received from a healthcare worker (also reported as an pharmacy technician) refers to a patient of unknown age. The reporter stated that a patient was inadvertently administered one dose of 0.5 ml VARIVAX (Merck) (lot# unknown) subcutaneous in instead of ZOSTAVAX at doctor's office on 07-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unknown that if the patient had sought medical attention. The reported stated in a direct shipment from Merck there was one vial of VARIVAX (Merck) within a ZOSTAVAX box of 10. 9 was ZOSTAVAX and one vial was VARIVAX (Merck). Should be 10 pack of ZOSTAVAX only. Product quality complaint was filed. Additional information has been requested.
Vomiting (resolved), unable to use right leg vaccinated with MMR and Vericella (ongoing-strange movement while crawling), Fever 102.2 resolved with Tylenol), injection site induration and inflammation (ongoing), Lethargy (ongoing), Jerky movements while sleeping (ongoing), diarrhea (resolved), poor appetite (ongoing) and congestion (ongoing).
Symptoms began roughly 12 hours post vaccination Pain in left armpit into her chest and neck. Reports red solid rash in both armpits and a quarter sized red patch at the injection site.  Notes One instance of diarrhea.
Generalized random location urticaria that does not control with antihistamines. Ne fever or malaise with no previous history of these lesions. They appear and disappear after 30-60 min.
On June 28, 2021, I was feeling very week and going to leave in a couple of hours, so I called my daughter in-law who's a nurse and she took me to Urgent Care. Once I arrived, they immediately put an EKG on me, my heart rate was over 250 so they transferred me to hospital for the first three days. They ran a few tests but I don't remember the name of the test, but they did do blood work and gave me medications. They Transferred me on July 1st, 2021, to a different hospital because that is where they handle their cardiologist patients. They did an echo cardiogram and some other test I don't remember the name, but they would zap my heart to slow down my heart rate. They gave me a Beta blocker, Metoprolol and Pradaxa. The continued doing blood work and monitor my heart on July 3, 2021, and On July 4th they released me around noon. One of my sons drove me back home. Once I got home, I went to see my Primary care doctor, on July 5th and she referred me to my Cardiologist and my first appointment was on August 23, 2021. On August 23, 2021, I went to see my Cardiologist. She took me off of the Pradaxa but kept me on the Beta Blocker. I am schedule to see her December of 2021.