chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (lot #, dose and route not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 25-MAR-2016, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as severe herpes zoster. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
Patient said about 8:00pm her arm started swelling and was sore. Today at 12:10 patient arm is swollen, slightly tight feeling and warm to touch. Instructed patient to apply cold compresses to site.
fast heartbeat//1st dose; warmth at injection site//1st dose; redness at injection site//1st dose; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (fast heartbeat//1st dose), VACCINATION SITE WARMTH (warmth at injection site//1st dose) and VACCINATION SITE ERYTHEMA (redness at injection site//1st dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced HEART RATE INCREASED (fast heartbeat//1st dose), VACCINATION SITE WARMTH (warmth at injection site//1st dose) and VACCINATION SITE ERYTHEMA (redness at injection site//1st dose). On 17-Jan-2021, HEART RATE INCREASED (fast heartbeat//1st dose), VACCINATION SITE WARMTH (warmth at injection site//1st dose) and VACCINATION SITE ERYTHEMA (redness at injection site//1st dose) had resolved.            No relevant concomitant medications were reported. No treatment information was provided.    This case was linked to MOD21-031476.
muscle aches; fever; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2020, the patient received the 1st dose of Shingrix. On 31st July 2020, 1 days after receiving Shingrix, the patient experienced muscle pain and fever. On an unknown date, the outcome of the muscle pain and fever were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain and fever to be related to Shingrix.  Additional case details were reported as follows: At 10 AM, the patient received the 1st dose of Shingrix. On 31st July 2020, the patient developed the effects. The reporter consent to follow up.
Patient with 2 COVID vaccines who admitted with a COVID detected test.  Provider d/c note:  "81-year-old male, history of extensive bilateral lower extremity DVTs, nephrolithiasis, CKD 3, type 2 diabetes, who presented to the emergency department on 10/16/2022 with abdominal pain.  Per patient, he woke up the morning of 10/16 with a steady ache in the suprapubic region that radiated to the bilateral flanks.  He was also experiencing rigors, nausea, diaphoresis, dysuria, urinary frequency.  Of note, patient stop taking majority of his medications about 2 weeks prior.  His sister advised him to go to the emergency department to be evaluated for possible urinary tract infection.  On arrival to the be emergency room, he was tachycardic, had leukocytosis, elevated lactic acid and a clinical picture consistent with septic shock.  CT of the abdomen pelvis showed a right ureteropelvic junction stone with mild hydronephrosis.       Brief Summary of Hospital Stay:   Patient had cystoscopy done with right ureteroscopy with right ureteral stent placement done by Urology on 10/17/2022.  He has completed a full course of antibiotics, with E coli noted in urine culture.  We have scheduled a urology appointment for follow-up stent and stone removal as appropriate.  Patient was also noted to have COVID-19 but did not have any pulmonary compromise.  We discussed quarantine measures per CDC guidelines.  The patient had a stress test that was not concerning for ischemia, but did note a low ejection fraction.  The patient agrees to follow with his cardiologist.  He had an acute kidney injury which is steadily improving, his medications have been adjusted accordingly.  Xarelto dose decreased for renal function.  Meds may need to be titrated with renal recovery.  We did recommend home care, but the patient refused.  I did discuss the patient's medications with him but he is unsure of what he takes.  I asked her pharmacist to review, they were unable to do so since the patient goes through the system.  I recommended that the patient and his family members review the meds as soon as possible with PCP.    the patient states his Lantus insulin was decreased to 20 units as an outpatient.  This will be continued, recommend PCP continue to titrate diabetes medications as needed.  The patient was advised to check his blood sugars 3 times a day and report them to his PCP.  He may require prandial insulin going forward.   Issues Requiring Follow Up:  Patient to see Urology in very close follow-up, and will also beats see PCP in follow-up.  PCP please please review above, and also review labs and imaging as below:  "
During vaccine administration, needle became separated from syringe and remained in patient's arm. Needle was gently removed with harm to the patient.  Full dose was given.
Hospitalized covid 12/17 and acute onset dyspnea with bilateral pulmonary emboli on date of admit
Pt was due to get DTAP and Polio separate but was given Kinrix by accident.  Pt did not have any reactions to this medication.  GSK was called along with the CDC.  Both companies state that even though the medication was given in error it poses not harm to the child and that the vaccine does NOT need to be repeated.
Started having muscle aches and a headache, took 2 aspirin 325mg (650mg) with some crackers and water, went to bed, and woke up around 1am and vomited.
Swelling, redness, pain incorporating whole girth of upper arm NOT AT INJECTION SITE. Initial involvement lasted 48 hours, took another 48 for symptoms to subside to the point that I did not need pain medication.
pt recvd 1st dose vax 15APR92 & 2nd 15MAY92 w/no adverse; pt recvd 3rd dose 15OCT92 & 72 hrs following vax exp vertigo, fever, chills, unable to move extremities, occipital pressure, hypotens, no vision, rt sided hemiparesis, freq urination
A few days after the injection I began feeling a pain in my left shoulder. Since I sleep on my side I thought it had somethig to do with sleeping on it wrong. When I went to my cardiologist for a checkup after the second shot  , 3/24/21, he diagnosed the pain in both shoulders as rotator cuff injury possibly caused by vaccine.
Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were reported. Treatment medication was not provided.
arm swelling and redness; arm swelling and redness; This spontaneous report was received from a registered nurse referring to a 59-year-old female patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.        On 08-MAY-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 milliliter, intramuscular; lot # and expiration date were not reported) for active immunization for the prevention of pneumococcal disease caused by the 23 serotypes contained in the vaccine (prophylaxis).         On the same day, the patient experienced arm swelling and redness. The patient did not receive treatment for the adverse events and has fully recovered. The causality assessment was not reported.
Redness, swelling and bruising at injection site with fever and crankiness for 36 hours and loss of appetite for 24 hours.
Shoulder pain where injected with motion limitation.  Hopefully it will go away. May seek doctor if it does not go away.
heaviness of the left arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (heaviness of the left arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced LIMB DISCOMFORT (heaviness of the left arm). The patient was treated with PARACETAMOL (TYLENOL) from January 2021 to January 2021 for Limb discomfort, at a dose of 2 doses. On 08-Jan-2021, LIMB DISCOMFORT (heaviness of the left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow-up information received on 28-JUN-2021 contains non-significant information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
pt recvd vax in 1988 & 14DEC92 lab eval revealed SGOT 124 & SGPT 49; @ the time of the report pt had not recovered; No further details were provided;
Patient was given Pfizer #1 at 5:20 PM he went into the waiting area with his mother.  I was called to the area because he felt faint, he stated he could not see or hear us, he was diaphoretic, he had no breathing problems, no facial edema, no wheezing or stridor, he was pale and clammy.  He continued to speak to us and was given water.  He then went back into the exam room and rested on the table with legs elevated.  He declined EMS.  His mother noted he has had this type of reaction before when watching a person get an IV or getting an injection. He was alert and oriented x 4, stated that he felt well and ambulated with steady gait from the clinic with his mother.
Patient walked away from the immunization area with his girlfriend about 5 minutes after receiving the flu vaccine, then passed out on the floor for several seconds. Patient's responded to us by calling his name, today's date, and where he is. Patient was able to stand up with little assistance and to walk back to immunization area. He sat down and being monitored for his pulse and temperature. His pulse was strong and slow, but his temperature was dropping from 94.5 F at 13:00 to 93.3 F at 13:06.  911 was called and 4 EMS staffs arrived at 13:13. Patient was then reviewed and monitored by EMS staffs. No special treatment has been done by EMS staffs. He was then left the facility with his girlfrend.
Pt. received Flu shot 9/8/11 developed hives on 9/9/11. History of asthma & food allergies (not eggs).
Information has been received from a registered nurse concerning a 16 female who on 24-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast). There was no concomitant medication. On 24-JUN-2008 the patient experienced faint after vaccination. The patient then revived and then fainted again within a short time while still in office. The patient recovered from faint after vaccination before leaving the office on 24-JUN-2008. Additional information has been requested.
Sore throat, burning eyes, fatigue. Symptoms persisted for one day, returned on the third day (10/14/2011, stopped on 10/16/2011. This vaccine was the high dose recommended for seniors.  It is the first time I have had a problem with flu shots.
Consumer received the first dose of the vaccine at age 17; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Consumer received the first dose of the vaccine at age 17) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Consumer received the first dose of the vaccine at age 17). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Consumer received the first dose of the vaccine at age 17) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant  and Treatment medications was reported.
Chills, dizziness, aching joints, chest pains, heavier than normal menstrual cycle.
REDNESS&SWELLING FROM THE SHOULDER TO ELBOW. REDNESS ALMOST COMPLETE CIRCUMFERENCE OF ARM. LT DELTOID 1 1/4 CM LARGER THAN RT DELTOID.
My left arm has swollen welt on it, hot to the touch, it has currently been there for 3 days and has yet to resolve. It is painful, throbs, and itchy. My left armpit is sore too.
Approx. 5 hrs after vaccine became slightly dizzy, nauseated took a nap approx. 2 hrs, and reported symptoms resolved.
tested positive for Covid-19; lack of efficacy; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) and DRUG INEFFECTIVE (lack of efficacy) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) and DRUG INEFFECTIVE (lack of efficacy). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) and DRUG INEFFECTIVE (lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive Positive.         No concomitant medication was reported. No treatment medication was reported.  Company Comment: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. This is a case of lack of efficacy of the product.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. This is a case of lack of efficacy of the product.
Erythema and induration, 4cm diameter, at injection site, 30 hours, post vax.
PATIENT LOST CONCIOUSNESS ALMOST IMMEDIATLEY FOLLOWING VACCINATION. 911 WAS CALLED BUT PATIENT REGAINED CONCIOUSNESS WITHIN MINUTES AND REFUSED MEDICAL ASSISTANCE. SHE INDICATED THAT THIS TYPE OF EVENT HAS HAPPENED PREVIOUSLY AND LEFT ON OWN ACCORD AFTER RESTING FOR ABOUT 15 MINUTES.
Severe headache within one hour of vaccination. Wheezing and trouble breathing 5-6 hours after vaccination, that remained for 4 days. I still have wheezing even 4 weeks after the shot. Fever of 100-101 within 12 hours of vaccination that continued for 3 days. Body aches within 12 hours that lasted for 5 days, in fact my legs still feel fatigued and there is pain behind my knees. Fatigue for 5 or 6 days after vaccination, I still don't feel like myself to include bouts of dizziness and lightheadedness that continue today.
35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient's year of birth is 1961. Concomitant medication was not provided. Treatment information was not provided.
Developed rash and swelling to ears, face, neck, then trunk by the next day pt receiving Td took allegra x 2-3 days, took ibuprofen for pain.
I journalled my symptoms from the moment I got vaccinated. My workplace mandated the vaccine. I will list all my worst symptoms here and go more in detail on the next page.  Chest Pain and Tightness (high d dimer levels); Significant Menstrual Cycle Changes; Extreme fatigue-9/4/21; Chills-9/4/21; Loss of appetite-9/4/21; Severe sudden sharp pain in left ankle-9/7/21; Pain in left knee -9/7/21; Phantom sensation then pain in right arm (non-injected arm); Pain in left shoulder...  I must emphasize that before this, I was a perfectly healthy 25 year old woman. No pre-existing conditions, no pain, not overweight.  Items 18&19:  High D-Dimer levels: I was feeling chest tightness on and off from 9/8/21. This escalated to chest pain on September 15th, to the point where I left work early to go to the ER. I strongly requested the doctor to run a d-dimer test. He told me I needed a CAT scan when he saw the results. They were nearly 3x higher than the top of the normal range for D-Dimer levels. Fortunately, there was no evidence of a pulmonary embolism.   Chest Pain and Chest Tightness: I never experienced this before the vaccine. Started 9/8/21, on and off. Still ongoing.  Significant Menstrual Cycle Changes--I had regular periods before. -Painful sudden cramps, even when I'm not having my period or near having my period -Spotting (I never spotted before) -Early 1-day period: I had a period for one day, September 12th. Way off my cycle. -Period started Sept 29th. For the 29th, 30th, and Oct 1st most of what I was passing were clots. Very large blood clots. On Sept 30th I got up 4 times during the night to change a completely full pad each time.   9/7/21: Sudden, sharp, severe pain in left ankle: I couldn't walk. This came on suddenly with no warning, as I was about to leave for work. On a scale of 1-10, it was easily a 10. This lasted for about 10 minutes, and then went away. Periodically, throughout the day I would feel a level 6 pain on my left ankle, so I would have to limp a bit, but then it would go away. Same day: While I was getting up from sitting down, I would feel pain in my left knee.  9/4/21 (day of vaccination) -Extreme fatigue: started 3:26pm, lasting the rest of the day. It felt like I was moving in slow motion. What normally would take me one hour to cook took me three hours. -Loss of Appetite: I had absolutely no appetite whatsoever. I literally had to force feed myself dinner. And I love food.  -Chills: At 8:00pm, my fingers started feeling very cold. At 8:16pm I had chills all over my body. Needed a warm blanket on top of the layers of clothing I was wearing.  Weird sensation in left arm (injection arm): 9/4/21 tingling and for lack of a better word(s), my entire arm felt strange. My left arm felt very light. I have never had this sensation before.   Phantom sensation/pain in right arm: 9/8/21 I felt the same pain and/or sensation in my right arm, the arm that did NOT receive the injection. It was in the mirror, or "same" location as the left side. At 7:27pm on 9/4/21 (injection day) I also felt pain in my right elbow. That pain went away at 7:30pm.
DEVELOPED SHINGLES, DIAGNOSED BY PHYSICIAN ON MONDAY 11/02/09
Given vaccinations and 24 hrs later developed a Headache and shifted - symptoms have improved.
dizziness, SOB, itching;pt reported as reaction similar to prior allerg rxn;DPH & epi given;
This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not reported. On 19-NOV-2018, the patient was inadvertently vaccinated with an expired dose of VAQTA 25/0.5 (unit unspecified) (lot # N020689 and expiry date: 22-OCT-2018) via intramuscular route for prophylaxis (expired product administered). No adverse effect was reported. There was no product quality complaint (PQC) reported. This is one of the several reports from the same reporter.; Sender's Comments: US-009507513-1812USA011184:
12 days after my 2nd covid vaccine I had my 1st seizure. I've never has any seizures before and since then I've had seizures nearly every day.  My symptoms during my 1st seizure were; couldn't understand words, couldn't remember my wife's name, convulsions, and migraine.
Had severe pain day of injection - unable to lift arm on own - used other hand to move it.  Significant pain to palpate at site of injection - no redness or hot.  Can not lift arm over head.  Had numbness around tip of deltoid for few days after shot.
14 days p/vax, pt exp afebrile seizure, lasting about 20 seconds; In ER exam including neurological exam was neg;
pt recv vax 545PM on 14FEB97 w/fever 104.0 temp & +sz;
Soreness and muscle aches in left arm and shoulder that began around 8 hours after the shot. Headache and fever of 99F around 16-18 hours after, took Advil and both went away after a few hours. Fatigue and sore arm for most of the next day. Fever of 100F started around 30 hours after the shot, took Tylenol. Symptoms gone after roughly 48 hours.