chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This study case was received from the investigator in a trial on 27 September 2012. A 31-year-old male subject with no reported medical history was found to have non-specific myocarditis 26 days after the subject had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 04 March 2012. Concomitant vaccinations included typhoid vaccine and anthrax vaccine both administered on 14 February 2012. Laboratory data including Troponin I, ECG, Echocardiogram, MRI (brain, spinal cord, heart) and Lumbar puncture were not available at the time of reporting. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
I had full diffused body pain and chronic fatigue and also like an itchiness on my skin and all over my body. I would get hot and cold flashes to hot then to cold, muscle and joint pains.
Information has been received from a nurse practitioner concerning a 49 year old female with a history of hypertension, polycythaemia Vera and allergies to soy products who on 12/09/2005 at approximately 2:00 pm was vaccinated with a first dose of Pneumococcal 23v polysaccharide vaccine 0.5ml (lot 650453/079P), in the right deltoid. Concomitant therapy that day included a dose of hepatitis A virus vaccine (unspecified) (+) hepatitis B virus vaccine (unspecified) (lot AHABB28AB), in the left deltoid. Concomitant therapy included metoprolol succinate (Toprol XL tablets) and candesarten cilexetil (Atacand). Subsequently, by 12/10/2005 midday, the patient was having painful, red swelling in the arm and also had a fever. She gradually developed worsening symptoms with gradually increasing redness and swelling of the arm, higher fever, pain and burning in the arm and headache. She felt very ill and spent the entire day of 12/10/2005 in bed. 12/11/2005 the patient was seen in the doctors office. She continued to feel ill, She had a constant headache in the frontal area of the head which had not been helped by using acetaminophen (Tylenol). She had a fever up to 102. The temperature seemed to be constant, did not return to normal when she used medication. The arm was painful and becoming increasingly more tender. The patients temperature was 101.2F. There was enlarged, tender lymph nodes present in the right axilla but not in the right supraventricular area or the olecranon area. There was an area of bright red, hot induration measuring 5" in height x 8" in the horizontal plane. The assessment was cellulitis. The patient was treated with dicloxacillin 500 TID for the next 7 days, ice to the area if need be, cetirizine hydrochloride (Zyrtec) 10 mg 1 tablet daily and acetaminophen Tylenol 1000 mg every 6 hours and if necessary she could add ibuprofen 600, alternatively. She was to rest and drink plenty of fluids and return in 24 hours. On 12/12/2005 the patient returned to the doctors office feeling better. She was up at 400am with fever and took ibuprofen Advil at that time. She had been perspiring heavily through the night and alternating feeling very cold with feeling hot. The arm did not burn as much as it did before but the redness was a little bit larger. The headache was gone. She felt a little better generally. Her temperature was 98.3F, and 45 minutes alter it was 99.2F. There was still substantial swelling and tenderness in the right axilla. The area of induration had increased from 5" x 8" to 8" x 10" although it was a little softer and mottled at the edges. It was hot to touch. The patient again was assessed with cellulitic reaction to Pneumococcal 23v polysaccharide vaccine. The patient was to continue with dicloxacillin, rest, and acetaminophen Tylenol and ibuprofen Advil as needed. The patient recovered on 12/28/2005. It was noted that the patient had never had a serious reaction to a shot. The reporter considered the patients experience to be disabling and an other important medical event (OMIC). Additional information is not expected.
Information has been received from a physician concerning a 5 year old female who on an unspecified date was vaccinated subcutaneously with a second dose of VARIVAX (Merck) (lot # not provided) for prevention of chicken pox. On an unspecified date the patient's arm inflamed with large blisters and cellulitis. Patient sought unspecified medical attention. On 15-FEB-2011, the patient had recovered. Additional information has been requested.
26JUL96 6AM pt awoke w/h/a, t102, redness approx 4" circle around site of inj began @ same time;temp dec to WNL by 29JUL96 redness went away @ this time as well;to MD AM rt arm sl warm to touch w/palpable hard mass (<1"diam) beneath skin
During the process of administering a Covid vaccine to a customer ,using the provided Vanishpoint syringe, Rph  did not administer the dose properly. The dose was given on 4/4/21, and a follow up with the patient (a family member) by the Rph the next morning, revealed that the customer had no soreness/pain in the arm or the injection site.  In reviewing the process, the Rph recalled  that in the act of administering the injection  felt resistance,(this was the first time using VanishPoint syringes) thinking the inner seal had reached the needle and not wanting to hit bone(small frame)  removed the needle and proceeded to retract the needle.  Rph felt a release and then the retraction of the needle. Some liquid was on the floor beside the chair, at the time the Rph thought it was disinfecting solution from cleaning  the booth and chairs. In reviewing the process the Rph is confident the patent did not receive the recommended dose.  Rph  contacted next level of management on 3/5/21 and was instructed to give another dose (after clinical team was notified)  as soon as possible in the opposite arm.  Dose was administered to patient approx 1:50pm on 3/5/21.
pt recv vax & exp SOB not requiring med tx;had prev been pre med w/DPH because p/1st had mild nausea;
pain on eyebrows; Pain in arm; muscle pain; stabbing pain in the head; This spontaneous case was reported by a patient family member or friend and describes the occurrence of EYE PAIN (pain on eyebrows), PAIN IN EXTREMITY (Pain in arm), MYALGIA (muscle pain) and HEADACHE (stabbing pain in the head) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Peripheral arterial disease.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced EYE PAIN (pain on eyebrows), PAIN IN EXTREMITY (Pain in arm), MYALGIA (muscle pain) and HEADACHE (stabbing pain in the head). At the time of the report, EYE PAIN (pain on eyebrows), PAIN IN EXTREMITY (Pain in arm), MYALGIA (muscle pain) and HEADACHE (stabbing pain in the head) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Computerised tomogram: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Headache muscle cramps Narrative: states had 2 days of muscle cramps and headache
Nearly immediately after receiving the vaccination, I developed tingling/numbness in bilateral legs. Approximately 15 minutes later, I noticed numbness near my nose on the right side of my face. Over the next hour and a half the tingling/numbness spread throughout other areas of my body such as, the backside of my upper arms, portions of my hands, lower back, torso, left upper side of my face, ears, tongue, along with other sporadic areas. There was sensation of muscle weakness upon standing in bilateral lower legs as well. During this time, I had an unusual sense of pressure in my neck and the tingling/numbness mentioned on my tongue was at the very back portion that made the sensation of swallowing feel very odd, but not difficult. Around this time I contacted the vaccination coordinator to review my current symptoms and was monitored for a short time and had taken a dose of Benadryl. The tingling/numbness on the left upper portion of my face developed a burning sensation. However, my eye sight was never affected throughout my reaction. After taking the Benadryl I went to sleep for around two hours and woke up with all areas of tingling/numbness, red that area and painful to the touch with a burning sensation. I took an additional dose of Benadryl and the symptoms were clear by the end up the night, next morning. Since that time I have sporadic areas and episodes of tingling/numbness, some in which appear to have the tingling/numbness at all times and are unrelieved with different efforts performed.
Gave a pediatric vaccine on 10/08/2022 with beyond use date of 10/14/2022.  The manufacture expiration date was 8/31/2022, has now obtained documentation that the vaccine is good thru 04/04/2023.   There was no other adverse effects.
I received the vaccine on Saturday 2/6/21 @ 2pm.  On  Sunday @ 4am I woke with fever 102.5 and chills, overall achy and had flu like symptoms.  Maintained fever throughout the day of 100.5-102.5 with Tylenol.  Late afternoon I started to feel better. But then at 6:30pm on Sunday evening  2/7/21 , fever spiked to 104.5 chills and shaking uncontrollably.   Severe lower abdominal pain and then nausea and vomiting started over the next few hours.  Around 9:30pm I had one instance of  diarrhea . nausea persisted but no more vomiting.  Over the next 48 hours fever of 102 and bloated and very uncomfortable abdominal pain.  Mid , left side as well as lower abdomen was sensitive to the touch.  On Wednesday 2/10/21  had extremely  bloody stools . temp over the following 2 days through Friday 2/12 was low grade 99-100.5 with Tylenol.  Cat scan done on 2/11/21 showed Colitis.  I have no medical history of Colitis.
SKIN RASHES, ARTHRITIS (KNEES & BACK), CHOLESTEROL & TRIGLYCERIDES PROBLEMS, BODY ACHES AND PAINS. BEING TREATED IN HEALTH CLINICS. 9/18/06 Received medical records from Health clinic which revealed patient experienced NIDDM, low back pain, neck pain, knee pain, hyperlipidemia, insomnia, erectile dysfunction, mood disorder & 30# unintentional weight loss.  Patient related mood disorder to chronic pain issues.  Received PT with some success.  Developed a painful skin disorder of knees & thoracolumbar area dx by dermatologist as psoriasiform dermatitis & lichen simplex/ss. 60 day Follow-up Information 11-OCT-2006: I have a permament disability; Diabetes Type II, arthritis (knees and back). I also still having skin rashes, a black mark in my back and body aches. I never was a sick person: my health probles became after I was injected of the above mentioned vaccines.
No adverse event; Caller reports expired dose of MMR II was administered.  No additional information provided.  No additional AEs or PQC reported.; This spontaneous report was received from an unspecified reporter regarding to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and  historical drugs, were not reported.  On 18-APR-2022, the patient was vaccinated with a expired dose of measles, mumps, and rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant human albumin) (M-M-R II)  0.5ml, subcutaneously (SQ)  (lot number T013003 has been verified to be valid, expiration date: 15-APR-2022), in addition with sterile diluent, 0.5 ml, SQ, (lot number U006619 has been verified to be valid, expiration date: 06-SEP-2023) (anatomical location was not provided) as prophylaxis.   At the time of reporting, no additional information was provided, furthermore no adverse events were reported.
Patient called 10/26/11 stating her arm was still very sore at injection site. I told her it was not normal for CF to last so long abd to call her doctor. I also called immunization services to make I was telling her correctly.
I flew out of state 05/21/2022 and when I got back home, I had head cold, sinus pressure in ears and throat and a low grade fever. I did test myself for COVID-19 that night and it was negative, and I found out later that you have to wait 48 hours after symptoms to test. I tried to self-medicate with over the counter medications for the entire week. I went to a walk-in clinic Friday and the sinus stuff started getting colors so they knew there was an infection, so they started me on Z-PAK and 3 days later I was better. After Z-PAK I was normal after a week or week and a half. I had to drive out of state 06/06/22 and on the way back I woke up with a 101 plus fever and had to self-medicate and went through 3-4 days of that. I went to a walk-in clinic, and they gave me 10 day dose of amoxicillin and I was on that for 2-3 days and was getting better. I did another COVID-19 home test the next day and tested positive. 06/10/22 was the 101 plus fever for 2 days and it was sometime the following week when I was put on amoxicillin. Both times it was all head and sinus, glands under ears, congestion, but my lungs were clear. When I tested positive, I went to the ER to get medications and the doctor checked my lungs again and it was fine and everything was in the head and the back of the throat and he didn't recommend either of the COVID-19 medications and said to go home and let it run its course. He did give me a steroid shot. Positive COVID-19 test was on 06/17/22.
This case was reported by a physician via call center representative and described the occurrence of generalized rash in a 54-year-old female patient who received SHINGRIX (batch number 3S354, expiry date 4th June 2020). On 9th February 2018, the patient received SHINGRIX. On 9th February 2018, less than a day after receiving SHINGRIX, the patient experienced generalized rash and itchy rash. In February 2018, the patient experienced discomfort. On an unknown date, the outcome of the generalized rash, itchy rash and discomfort were unknown. It was unknown if the reporter considered the generalized rash, itchy rash and discomfort to be related to SHINGRIX. Additional details were provided as follows: There were two reporters who were immunization program coordinators at the clinic who oversee the primary care Immunization program. They stated they received this information from other physicians and nurses regarding the consumer's product experience. Within about 12 hours after receiving the SHINGRIX vaccine, the consumer reported a non-injection site rash. The patient had a generalized rash across the body involving the trunk, described specifically as a flat itchy rash over the chest, back, arms and up the neck. Less than a week after receiving SHINGRIX, the patient had significant discomfort. The patient was alive at the time of reporting, and did not require overnight hospitalization for any of the reported symptoms. The reporter's grant permission to be contacted. The reporter's declined to provide concomitant medications or any further related details beyond what was documented above due to time constraints. This call was transferred to the team. The supervising MD field name was for a nurse practitioner. It was unable to clarify what was meant by significant discomfort during the call due to time constraints.
Pfizer 3/13/21, 4/10/21, 10/7/21. Positive on 9/18/22
I started developing a lower back pain that does not go away and I cannot associate it with anything else. Thinking it could be renal pain, I consulted with an urologist while in vacation, but my kidneys are okay.  They suggested there is something to do with my muscles /spine in my lower back. The doctor prescribed me a temporary anti-inflammatories, muscle relaxant and pain medication and is helping . I cannot asure it is due to the COVID vaccine, but I can. It associate this lower back pain with anything else. I just wanted to reported
Rt upper arm hyperpigmentation ? and discoloration not reddened or indurated 6 cm by 3 cm not painful not hot area started swollen painful that resolved.
covid-19 janssen shot given  and seated in observation area. pt in observation area appeared faint and eyes rolled back. RPH, EMT, and store management all called to scene. Pt was monitored and clear to drive home.
Atrial fibrillation. Chronic AF controlled with carvedilol and lisinopril. Cardioversion performed. Converted back to NSR.
Sore arm; Rash on thigh area; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and RASH (Rash on thigh area) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B7114 and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and RASH (Rash on thigh area). At the time of the report, PAIN IN EXTREMITY (Sore arm) and RASH (Rash on thigh area) outcome was unknown.            Concomitant medications were not provided by reporter. Treatment information was not provided by reporter. Action taken with mRNA-1273 in response to the events were not applicable.
I have had a ringing in my ears since my second dose of the vaccine, apparently known as Tinnitus. I have discussed with my ENT doctor as well as an audiologist that I was referred to. Both mentioned that I was not the only one to come in and report this. I took a hearing test and appeared I had not lost any hearing at the time of the test. However, it?s been about 7 months since the second shot and the ringing is still there. Both ears, all of the time.
SM developed influenza-like illness with Fever, chills, myalgias, and HA 5 days  s/p dose 1 of Moderna Vaccine.  Pt previously infected with COVID 19 and diagnosed 12 days prior to vaccine administration
Two TIAs lasting c. 10 minutes each, about 10 minutes apart on 3/13/2022. Tingling on entire L side. Visual impairment in left eye lasting c. 10 minutes during 2nd TIA.  I was admitted to a Cardiology Unit at Hospital via their ER.   Still have some balance impairment & difficulty finding information in my brain.
1. Patient was admitted Pfizer monovalent Covid Vaccine after authorization for use had expired April 18, 2023 2. Patient was prescribed Pfizer Bivalent and was administered Pfizer monovalent in error.
Information has been received from a physician who heard that an adult female who was vaccinated with VARIVAX (Oka/Merck) (route and site was not reported) experienced Guillain-barre syndrome after receiving the VARIVAX. Guillain-barre syndrome was reported as immediately life-threatening. The patient sought unspecified medical attention. The outcome was unspecified. The physician had no further information to provide. Attempt made to verify the existence of an identifiable patient and reporter was unsuccessful. No further information is available.
I have had a sore left arm since receiving the first dose on 1/16. VAERS report was put in and e-confirmation 294505. First dose was given in the right arm but caused pain in the left arm. With the 2nd dose due to the pain in the left arm, I got the 2nd dose in the right arm. There was just a sting when they put in the needle in. Today 2/10/2012 around 2-3 am I woke up and my arm is swollen. It is a little discomfort when I move my right arm.
PT STATES IMMEDIATELY AFTER RECEIVING VACCINE OF 2ND COVID BOOSTER, SHE EXPERIENCED A BURNING SENSATION ALL OVER HER SKIN, HER LEFT ANKLE AND LEFT CALF HALFWAY UP TO HER KNEE BECAME SWOLLEN (IT WOULD REDUCE W ELEVATION BUT HAS NOT COMPLETELY RESOLVED), EXHAUSTION, MUSCLE SORENESS, AND STATES THAT A CYST-LIKE NODULE ROSE ON THE MEDIAL END OF HER RIGHT CLAVICLE AND THAT NODULE HAS SINCE BECAME MORE FIRM. PT HAS OPPORTUNITY TO SCHEDULE W DERM AND W PCP. PT REPEATEDLY SAID IT FELT LIKE HER THYROID WAS BURNING.
This non-valid spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On unknown dates, unspecified patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (strength, dose and route of administration were not reported) lot # R007722, expiration date 10-MAR-2020 and with ROTATEQ (strength, dose and route of administration were not reported) Lot # R005869, expiration date 23-OCT-2019, both for prophylaxis. The vaccines were stored in the lowest temperature below 36 degrees Fahrenheit/ 2 degrees Celsius (1.16 degrees Celsius) for 30 minutes and the highest temperature above 47 degrees Fahrenheit/ 9 degrees Celsius (9.08 degrees Celsius) for 4 hours and 15 minutes (date was not reported). There was a data logger involved and no previous temperature excursion. No adverse effects were reported.
Significant inj site pain, fever, malaise, body aches, severe neck and headache continues thru today.   Historically Pfizer caused 6-8 hours of symptoms next day... This has been nonstop
Pt (L) arm 24 hour after flu shot given was red, swollen & warm to touch. Pt states she slept a lot on yesterday because she just didn't feel good. Today arm now has a mild rash noted from shoulder down to wrist still warm to touch & swollen today.
I received my second Moderna shot on 4/14/21 at 2pm. When I woke up the next morning on 4/15/21 at 0600 I had a headache. I got out of bed and walked to my kitchen to get some ibuprofen. As I went to get water from the kitchen sink my vision went black and I fainted hitting my head on the kitchen island. When I came to, I was lying on the kitchen floor with excruciating pain on the left back of my head.  Since then I have been diagnosed with syncope and concussion.
Headache, severe chills and body ache lasted approximately 12 hours, chills disappeared moderate headache and severe body ache continued off and on for the next 2 days.
Fever and chills x 12 hours Severe headache x 5 days Enlarged supraclavicular lymph nodes bilaterally Tender axillary lymph nodes bilaterally Nausea x 5 days
pt recv vax;MD reported fever, achiness in jaws,HA & arm aches on 16aug95;came from work & "felt he might pass out";17aug severe HA w/ eyes hurting,T approx 102,sl rash;apap did not relieve;in er;given pain pills for HA;improved;also n&v;
Extreme spinal pain, cervical region. Went to a chiropractor assuming it was bone related. No relief so went to my PCP for muscle relaxant because the doctor felt it was more muscle related because the muscles surrounding my spine were rigid. Two days after taking a muscle relaxant I got tinnitus in my ear.  The next morning I woke up almost dead in my left ear. I went to emergent care and was referred to ENT. I was then diagnosed with sensorineural hearing loss of my left ear.
PNEUMOVAX 23 given Rt deltoid 5/19/16. Pt has Crohn's - immunocompromised. 5/21/16 6" red raised warm reaction Rt arm/fatigue.