chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Post vaccination, in December of 1997 the patient developed varicella. Additional patients including the patient's sister, had similar experiences following exposure to varicella virus vaccine live. Follow up information received on 08/01/2000 from the patient's mother stated that "her daughters received varicella virus vaccine live two years ago and one of her daughters broke out in a rash and the other daughter had more lesions than usual." She also reported that the "incident happened 2 years ago. Additional information has been requested.
Patient complained of itchy feeling to the left deltoid area of injection site. Patient took band-aid off and stated she has a history of itching with adhesives prior. Alert and oriented x3. Respirations easy and unlabored. Skin pink warm and dry. Denies any SOB, feeling of doom, etc. Sipped on H2O without difficulty swallowing.  Upon inspection of injection site, no swelling, rash, hives, etc. Denies N/V.
shot doesn't / work/ Suspected Vaccination failure; shot doesn't / work; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she was a living proof of the Shingles shot as did not always work. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Pt. recv'd the flu vaccine on 10/8/11. After getting the vaccine the pt. describes herself as being very weak, having behavior changes, being dizzy.
t104 ax; treatment APAP brought temp to 102 ax; elevated temp lasted x 24 hrs;
This spontaneous report was received from a physician refers to a 21 month old female patient. The patient was generally healthy and had no medical history, concurrent conditions, drug reactions/allergies and concomitant therapy reported. On 28-JAN-2017, the patient was accidentally vaccinated with a full dose of GARDASIL 9 (dose: 0.5 ml) via intramuscular route, for prophylaxis. Physician reported that on 28-JAN-2017, the patient who was supposed to be vaccinated with hepatitis a vaccine, inactivated (Manufacturer unknown), but was accidentally injected with GARDASIL 9 by a medical assistant because of logistics. He stated that GARDASIL 9 was supposed to be given to a teenager. He was present at the time of vaccination and was asked to see the child. He reported that on the same day after vaccination, the patient developed swelling and ecchymosis at injection site. No treatment was given for the adverse events. Physician mentioned that he contacted the patient's mother on 30-JAN-2017, and she informed that the patient was running around and was doing fine. Outcome of the events, swelling and ecchymosis at injection site was unknown. Causality assessment was not provided. Additional information has been requested.
Patient reported shortness of breath, nausea, and hives beginning on day of vaccination. Was unable to verify this report.
My left arm is very sore with a 2 inch diameter blotch on it. The blotch is red and raised. When I touch it, it is sore to the touch.
My first two vaccines barely affected me, but the booster was so bad I was completely incapable of functioning for 2 days.  I had severe headache, body ache, and  chills.  My injection site swelled to the size of a baseball.  I slept for 12 1/2 hours straight.  When I stood up, I was dizzy and had to hold on to walls to keep from falling.  This lasted several hours.  This was particularly concerning because it was so completely different from the first two injections which caused very little reaction at all.
I'm 100 percent disabled by the Moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I'm 100 percent disabled by the Moderna shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I'm 100 percent disabled by the Moderna shot) (seriousness criterion disability). At the time of the report, VACCINATION COMPLICATION (I'm 100 percent disabled by the Moderna shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment  Very limited information regarding the event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the event has been provided at this time.  Further information has been requested.
PREVNAR 13 was given IM on 5/19/15 to left deltoid. No complaints or distress noted. On 5/25/15 a warm red area was noted to left deltoid. Resident admitted to scratching area.
Pt. Received second covid-19 vaccine today. After 15 minutes she reported numbness to her left side of face. Also a mild headache and dizziness. She is alert and oriented times four and equal good strength to arms and legs bilaterally. No facial droop noted. Vital signs at this time (13:23): BP: 138/83, HR: 75, O2:98%.She denies any medical history or allergies at this time. Benadryl not given due to no ride. Provider was called and given report. She advised to do a stroke assessment and call 911. Vitals at this time (13:36): BP: 165/85, HR:72, O2: 99%. LVN called 911 and gave report. Advised by 911 to not provide food or liquids. As paramedics pulled up, Pt. Complained of difficulty swallowing. Vitals at this time (13:40): BP:130/49, HR: 72, O2:99%. Paramedics took over scene, assessed Pt. And advised her to go to the hospital. Then transported Pt. To nearest hospital.
Feverish aches in ankles elbow and back. Injection site is red and swollen and hot.
First Vaccine given on 1/13/2021.   Moderna. Unknown Lot# or injection location. Pharmacy
Elevated HBP and flush 4 hours after vaccination  12/30 101.2 fever, headache, joint pain upper body 12/31 no fever, extreme fatigue and headache  1/1/2021 headache no other symptoms
This spontaneous report has been received from a registered nurse who reported that unspecified number of patients were administered GARDASIL which underwent supported excursion in December 2013. Dosage and lot information were not provided. All telephone attempts to obtain follow-up information had been unsuccessful. This is one of several reports from the same reporter and is linked to 1403USA010165, 1404USA001101, 1404USA001100, 1404USA001099. Additional information has been requested.
Vaccine Administered at Inappropriate Site/Route; Large Red Area On Right Arm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 477S3, expiry date 17th October 2021) for prophylaxis.   On 6th August 2019, the patient received the 1st dose of Shingrix (subcutaneous). On 6th August 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. In August 2019, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix on the right arm via subcutaneously, which led to intramuscular formulation administered by other route. Less than week after vaccination, the patient experienced a large red area on right arm. The reporter wanted to know how to proceed. The reporter consented to follow up.
Rash that breaks out every once in while on arms. Was pregnant when recieved the vaccination. Daughter has a really weak immune system. Is always sick. Carries the common cold for long periods of time.
pt devel Henoch Schonlein purpura 2 days following vax including joint swelling & pain, purpuric rash on buttocks & extremities;
4/6/ 21 within hours of the vaccine:  extreme sleepiness as if I had been drugged , excruciating headache for hours but I could not open my eyes or full wake up, trouble breathing, but could not open my eyes or fully wake up. 4/6/ 21 5pm awake but very groggy  headache is not as bad. Took an alleve which helped but the headache did not go away. 4/7-4/12  bad headache exacerbated by  going outdoors in sunlight. persistent grogginess every  morning. very difficult to wake up. I  run several days a week was able to  complete 4 miles no problem .  but headaches would be worse being outside in daylight. 4/13 I read news of headaches and  clotting rx  so I saw my Dr.  did blood work and scheduled for MRI.  blood work /platelets came back WNL . MRI was cost prohibitive for me so I cancelled MRI would follow up with MRI if headaches worsened and or developed other symptoms. 4/13-4/21 Persistent , annoying headache but improving somewhat. Still have difficulty waking up in the am. 4/22 First day that headache mostly was not present. Difficulty waking up in the am still.  4/17
Got Immunization 9/8/06 developed water diarrhea on  9/11/06, and on 9/12/06 blood noticed with diarrhea, stool culture sent 9/12/06.
Patient admitted to the hospital on  7/26/2021.  She presented with shortness of breath, malaise,  and fever.  Covid-19 positive.  She was started on Dexamethasone, but no other known Covid-19 interventions secondary to Kidney Transplant in 2017.  She was discharged on 7/31/2021.  During admission she was noted to have pneumonia, severe orthostatic blood pressure issues, and severe weakness.  Bp meds were held for orthostatic bp issues as well as IV fluids, fludrocortisone, and compression stockings.  Discharged in stable condition.
Swollen neck lymph node; This spontaneous case was reported by a non-health professional and describes the occurrence of LYMPHADENOPATHY (Swollen neck lymph node) in a female patient of an unknown age who received mRNA-1273 for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen neck lymph node). At the time of the report, LYMPHADENOPATHY (Swollen neck lymph node) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Metal Mouth; Fatigue; Chills; sore; This spontaneous case was reported by an other and describes the occurrence of PAIN IN EXTREMITY (sore), DYSGEUSIA (Metal Mouth), FATIGUE (Fatigue) and CHILLS (Chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore). On 01-Apr-2021, the patient experienced DYSGEUSIA (Metal Mouth), FATIGUE (Fatigue) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore), DYSGEUSIA (Metal Mouth), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product is not provided.  Patient drinking 12 cups of water that day for treating sore.
8days p/vax pt exp seizure lasting 5min (full body), temp 104-R w/tylenol, 102 temp
7/12/05 Pediarix given. 9 AM 7/13 Mom reports temperature 102.4 and headache. No other signs or symptoms. 10 AM 7/14 Mom reports temperature 101.0 but no headache. No other symptoms. 2 PM 7/15 Mom reports symptoms resolved. Report completed.
PATIENT RECEIVED MODERNA VACCINE FOR DOSE 1 AND DOSE 2. INADVERTENTLY RECEIVED PFIZER VACCINE FOR DOSE 3.
About 1 week after second dose began having attacks of Atrial Fibrillation. Occured various times of the day. Mostly heart racing and irregular heart beats.
Complain of Left side of throat  "a little swollen".  Medicated with Zyrtec 10 mg po, ,Prednisone 40 mg po, , Pepcid 20 mg po.  Monitored for approximately 1.5 hours.  felt better, advised to follow up with primary care physician as needed.
my lymph node on the right side; is swollen and little bit ''laid up''; something is like growing for my thyroid, it is like a ''penny'' and its very painful; I can''t touch it; pain is not going; my thyroid is very painful, I can't touch it, you know.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 07Mar2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1), administration date: 2021, for COVID-19 Immunization, reaction(s): "Dizzy"; Bnt162b2 (DOSE: 2), administration date: 2021, for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "my lymph node on the right side; is swollen and little bit ''laid up''"; THYROID MASS (non-serious), outcome "unknown", described as "something is like growing for my thyroid, it is like a ''penny'' and its very painful; I can''t touch it; pain is not going"; THYROID PAIN (non-serious), outcome "unknown", described as "my thyroid is very painful, I can't touch it, you know.".  The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Linked Report(s) : US-PFIZER INC-202200411099 same patient and drug, different event separated in time
Severe headache, fatigue, muscle aches (particularly in neck), fever up to 100.7 F, tendon pain right achilles.  Noticed symptoms upon waking in the morning; temp was 99.7 upon waking and increased during the day. Treated with rest and fluids all day, took NyQuil at bedtime. Temp was back to normal, no headache, and only slight muscle aches upon waking on the 22nd.
Swelling, nausea, fever and left arm, left hips, left shoulders feel tingling, crawling and also numbness in shoulders areas. Everything is getting better.
Pt recvd series of 3 EngerixB vax 22FEB91, 22MAR91, 22APR91; Antibody test done 2 months p/last dose indicated pt was a non-responder; later tests indicated pt seroconverted;
Headache  Narrative:  DAY 2-7: CONSTANT HEADACHE-pain would ebb OTC medication-never went completely away until day  8.
Hospitalized 10/29/2021; COVID-19 positive 10/26/2021; fully vaccinated  BRIEF OVERVIEW: Discharge Provider: MD Primary Care Provider: DO Admission Date: 10/29/2021 Discharge Date: 11/3/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Dehydration [E86.0] Hypokalemia [E87.6] Transaminitis [R74.01] Severe sepsis [A41.9, R65.20] AKI (acute kidney injury) [N17.9] Pneumonia due to COVID-19 virus [U07.1, J12.82] COVID-19 [U07.1] Sepsis [A41.9]   HOSPITAL COURSE:   75 yo male with history of CAD, PE/DVT, prostate CA, and Gilbert's syndrome.  He presented to Hospital on 10/29 with symptoms of dyspnea cough, fever, weakness.  His code PCR was positive on 10/26.  In the emergency department the patient was found to be hypoxemic requiring 3 L of oxygen, hypotensive despite 3 L of fluids and therefore was started on norepinephrine and admitted to intensive care unit for further management of septic shock.  Other labs are notable for an acute kidney injury, elevated troponin and elevated procalcitonin.  Patient was started on IV antibiotics.  Infectious Disease were consulted.  Blood cultures were drawn.  Epinephrine was able to be weaned down by the following day.  CT imaging revealed a hepatic abscess for which Interventional Radiology were consulted and patient underwent image guided drain placement on 10/31.  Cultures from the drain did not grow any bacteria.  Her blood cultures did return positive for fusobacterium nucleatum.  Antibiotics were adjusted to ceftriaxone and Flagyl while in the hospital.  Infectious Disease recommended a 4 week course of levofloxacin and Flagyl on discharge. They will follow up with patient in 3 weeks in their clinic.  Of note, patient's blood cultures were not back yet at the time of discharge, however telephone discussion with Infectious Disease Service today felt to be okay to discharge on above regimen and will follow up on susceptibilities, notify patient if any changes need to be made.   Regarding his covid diagnosis, patient was treated with the severe and will complete a ten-day course of Decadron at home.  He was able to wean off of oxygen and remained comfortable on room air without additional COVID-like symptoms during the last days of his hospitalization.   Cardiology were consulted for NSTEMI, recommended heparin drip with transition to dual anti-platelet therapy for 1 year with possible outpatient stress testing on follow-up appointment.   Patient is being discharged home in stable and improved condition.  He has been instructed to follow up with interventional Radiology for drain removal in the next couple of weeks.  He will follow up with primary care physician for regular health maintenance.  His losartan was held on discharge due to lower blood pressures, this could be resumed in the outpatient setting if tolerable.
whole arm is swollen; The whole arm is not sore, only the upper part where she received the vaccination; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8731), via an unspecified route of administration, administered in arm on 27Jul2021 19:00 (at the age of 79-years-old) as dose 1, single for covid-19 immunisation. Medical history included ongoing blood pressure high (this for quite a few years/mother had high blood pressure along with her sisters), macular degeneration (diagnosed a couple of years ago), heart murmur and cancer (dad had cancer). The caller has a ton of allergies so she was hesitant about getting the vaccine. Prior to vaccinations, no medication received within 4 weeks. Investigation Assessment was no. When the caller takes the flu vaccine she gets the regular one, not the one that the elderly people get because of all of her allergies. Concomitant medications included allopurinol (ELAVIL); lorazepam (MANUFACTURER UNKNOWN); omeprazole magnesium (PRILOSEC); folic acid (MANUFACTURER UNKNOWN); pyridoxine hydrochloride/riboflavin (VITAMIN B2 + B6); all for an unspecified indication, from an unspecified date and unknown if ongoing, lisinopril (MANUFACTURER UNKNOWN) for blood pressure high, start and stop date were not reported; carvedilol (MANUFACTURER UNKNOWN) for blood pressure, start and stop date were not reported; telmisartan (MANUFACTURER UNKNOWN) for blood pressure high, start and stop date were not reported; dicycloverine hydrochloride (BENTYL) for stomach, start and stop date were not reported; paracetamol (TYLENOL) for aches and pain, start and stop date were not reported; ondansetron (ZOFRAN MELT) for nausea, start and stop date were not reported. The patient received her first dose of the Pfizer COVID-19 Vaccine yesterday, 27Jul2021 19:00. This morning her arm was sore and swollen all the way down the arm. The whole arm was not sore, only the upper part where she received the vaccination but the whole arm was swollen. Caller would like to know if this was normal. Caller states that she would see her Nurse Practitioner tomorrow, she comes there twice a week. Patient has taken her blood pressure medication and states she could take Tylenol and anything else she can do. The caller was calling about the Pfizer covid vaccine. The caller had the vaccine around 7:00 last night. The caller knows the arm being sore was normal but her whole arm was swollen. This event happened after the first dose. These events started this morning. When the caller lifted her sleeve she noticed her whole arm was swollen. This was the same arm that she received the vaccine in. The event does not require a visit to emergency room and physician office. The outcome of events was not resolved.
Patient states went to ER due to "bad reaction". No specifics given. Attempted to contact patient to no avail. Was in pharmacy less than 24 hr after incident.
sick; Initial information was received on 08-Oct-2020 regarding an unsolicited valid non-serious media case from a consumer or non-healthcare professional.  This case involves patient (unknown demographics) who got very sick (illness), after receiving INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE  The reporter stated that, its not a myth, that the patient was not sick until he/she got the shot. It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine: Influenza Vaccine was also unknown.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on lot number for this case.
This report was received from the investigator in the above mentioned trial on 12 April 2010. A 27 year-old male subject received the following vaccine on 15 January 2009: ACAM2000 (lot number not reported). Twenty days after vaccination, the subject was diagnosed with unspecified acute pericarditis and unspecified disease of the pericardium. The subject had no reported medical history. The subject had an abnormal troponin I on 28 January 2009 (results 00.71). No other information was provided. The outcome was not reported. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.