chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer Dose 1 2/20/21 (EN6200) Pfizer Dose 2 3/13/21 (EN6204) Pfizer Dose 3 11/12/21 (lot NA) COVID Positive 1/9/22  1/9/22: He is a 74-year-old male with a history of HTN, BPH, obesity, depression/anxiety and chronic backache.  He was brought to the emergency room this morning because of confusion.  History was obtained from ER documentation as patient is unable to give the history because of current mental status.  Patient had COVID-19 home test yesterday because of body aches, pain and shortness of breath and was positive.  However this morning upon awakening he became quite confused and this prompted the wife to call the paramedics and he was brought to the emergency room.  At the ER he was disoriented and unable to give coherent history.  The vital signs significant for fever of 100.6° F and O2 saturation of 88-89 % on room air.  Other vitals were normal.  Significant laboratory test K 3.1, CR 1.33, ALT 125, ALT 114 and ALP 126. The CT angiogram of the chest was negative for PE but there is mild patchy right upper lobe infiltrates.  CT scan of the head without IV contrast revealed no acute abnormality except for age-appropriate atrophy and microvascular disease.  Of note is that patient has been taking daily steroid tablet prescribed for him by the PCP for recurrent pruritus.  1/14/22: This patient had a colonoscopy several weeks ago, then became dehydrated, weak and was admitted to the hospital with weakness and confusion, but also tested positive for COVID-19.  He had minimal infiltrates and his chest x-ray but did receive IV antibiotics and antiviral medications.  He has not required any supplemental oxygen the past few days, but is still too weak to return home. We are recommending skilled nursing facility.  His confusion was felt to be due to the COVID-19 infection and he had no other symptoms suggesting alcohol withdrawal or seizures. The MRI did not show any signs of a stroke.
Patient presented to Hospital on 2/18/2010. Pt was found to have symptoms consistent with Guillain-Barre syndrome including bilateral weakness, decreased deep tendon reflexes and an acute onset.
Axillary Lymphadenitis. Swelling, tenderness of axillary lymph node. No cervical lymphadenopathy. Woke up and noticed day after injection in the side he got the injection in. No reaction at the deltoid site of injection. No fever. No chills. Mild malaise only.
Initial report was received on 28 September 2012 from a consumer who is also the patient. A 75 year-old female with history of hypertension, high cholesterol and allergy to sulfites had received on 08 November 2011 an intramuscular left arm injection of FLUZONE, lot number UH486AD and two hours after vaccination, experienced syncope that lasted a few minutes. The patient was transported to hospital by ambulance and was admitted overnight. The patient had a CT scan (results were not reported). The patient reported to have had previous doses of FLUZONE vaccine. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: none.
Two days after second Covid-19 vaccination I experienced moderate generalized pain concentrated in major joints which affected daily activities and movement. Pain was 5-6 on 10 point scale and lasted approximately one month.
11:15 Post vaccination reports feeling dizzy and tired, denies any additional symptoms; medical monitoring x 30 min, remains oriented w/coherent verbal responses; post rest reports "feeling better"/ noted symptoms improved. Released from facility w/ known site volunteer.
High blood pressure; Heart palpitations; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High blood pressure) and PALPITATIONS (Heart palpitations) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (High blood pressure) and PALPITATIONS (Heart palpitations). At the time of the report, HYPERTENSION (High blood pressure) and PALPITATIONS (Heart palpitations) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) has high blood pressure.   No concomitant medications were reported. It was reported that, patient was asking if it was necessary that she gets the 2nd booster, she stated that she had received all 3 shots and had high blood pressure, heart palpitations but unable to confirm if the symptoms started after patient received the vaccines. No treatment medications were reported.   Reporter did not allow further contact
It started with a headache, which I didn?t think much of it. After a week to 10 days, I felt the pressure on my right eye socket, then developed into ocular pain accompanied with a headache. It took place on and off, sometimes more severe than others. Since it was holiday season, I couldn?t get an appointment with an ophthalmologist until January 9th, and was told I had macular edema. I was referred to and saw a retinal specialist on January 16th. I was told I did have macular edema but a little redness which didn?t need any treatment, other than a followup in 6 weeks. At this point, I still feel the discomfort on my right eye and headache continues. I am thinking  about my next step if the headache persists.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information on patients' concurrent conditions, medical history or concomitant medications was provided. On an unknown dates, unspecified number of unspecified patients received improperly stored doses of M-M-R II injection, lot # K002527, expiration date 18-FEB-2016 (dose and route of administration were not reported). No adverse effects were reported. This is one of the several report received from the same reporter. Additional information has been requested.
Dizziness, spinning, off balance, and sinus pressure.   The dizziness and spinning started less than 24 hours after the vaccine and I still have it 6 days later.  Did a visit on Sunday the 8/1/21 and they prescribed me a medicine for dizziness.  I also went to the doctors again on 8/3/21 for all the systems.  They stated I had vertigo and now the beginnings of sinus infection.
Onset of Guillain-Barre 10 days after influenza vaccination. Patient was consulted to neurology and hospitalized with treatment with IVIG at another facility. 11/5/09 Medical records received for date 10/30/09. Pt referred to physical medicine and rehab spec. for electrodiagnositc testing for poss. GBS or other polyneuropathy.  Pt. states had seasonal flu vax Oct 7. tx. same day for basal cell carcinoma. Pt/ c/o numbness and fatigue in both hands on 10/17. Pt had PE on 10/20 by PCP and mentioned of sx. Next several days sx. worsened, numbness weakness in legs and arms. Assessment: weakness and paresthesia with electrodiagnostic evidence of a proximal demyelinating polyneuropathy, probably acute inflammatory demyelinating polyneuropathy GBS, onset 10 days after influenza vax. 10/30/09 Neuro consult impression: GBS, possible rx to flu vax, intrinsic foot muscle atrophy. Recommend IVIG tx.
Developed pins-and-needles and numbness of bilateral upper and lower extremities day after receiving booster vaccine.  Pins-and-needles resolved after few weeks but now chronic numbness of bilateral upper extremities with occasional pins-and-needles involving bilateral hands/wrists, worse at night.
Received Pfizer vaccines on  1/28, 2/18, 9/30/21 COVID-19 positive by PCR on 1/11/22 admitted to hospital on 1/11/22 w/ SOB, cough, weakness, fatigue, A-fib; diagnosis of COVID pneumonia
Extreme fatigue. Neuropathy in both hand and both feet. Crept up to my wrists and also went up to my knees. I still have a lot of pain in my feet and weird sensations and numbing intermittently in my hands and feet. I feel unstable on my feet at times and am still struggling with fatigue.
Debilitating anxiety attacks. No prior history of anxiety attacks. The first week after the shot the anxiety attacks lasted 3 hours and happened at least 3 times a day. During those attacks I could not breath and every muscle contracted. I believed I was having a heart attack. After the first week the anxiety attacks went down to about one a day  and lasted about an hour or two. For a full two weeks I had debilitating vertigo, nausea, ringing in my ears, heaviness in my left arm and left jaw, and spells of uncontrollable shaking.
Fever and bursitis of shoulder one day after. headache and blurred vision 3 days afterwards.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 04-SEP-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: K003822, expiration date: 14-MAR-2016. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
MULTIPLE PULMONARY EMBOLISM; MULTIPLE BLOOD CLOTS; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a health care professional concerned a 55 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose not reported, 1 total, on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient developed multiple pulmonary embolism included multiple blood clots. On 19-MAY-2021, after 4 week of vaccination, the patient was diagnosed with suspected covid-19 infection (suspected clinical vaccination failure) and was not doing well. The patient got hospitalized. Number of hospitalization days was not reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, suspected clinical vaccination failure, multiple pulmonary embolism and multiple blood clots was not reported. This report was serious (Hospitalization Caused / Prolonged and Life Threatening). This report was associated with product quality complaint number: 90000180239. The suspected product quality complaint has been confirmed to be not voided based on the PQC evaluation/investigation performed.; Sender's Comments: V0:20210539965-covid-19 vaccine ad26.cov2.s - multiple pulmonary embolism,multiple blood clots,suspected covid 19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0:20210539965 covid-19 vaccine ad26.cov2.s - suspected clinical vaccination failure This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically:SPECIAL SITUATIONS
8/5/21 Patient reports cough, nasal congestion x few days; tested positive for covid 8/10/21 hx covid vaccine developed covid infection; hx RA on minimal rituxumib. Chief complaint is covid hypoxia
TIREDNESS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tiredness. This report was non-serious.
I started with head congestion and my sinuses were killing me. I could not wear my glasses because they were too heavy for me. I felt like my upper teeth hurt. I advised to go to the emergency room to get it treated. I was already treating it with over-the-counter medicine. For a whole week I had a sore throat and headache. I was extremely cold. I took SUDAFED but it did not help with my symptoms. I was taking over the counter nasal spray. It would help for a couple of hours, but it became too much for me. The mucus started to go down my throat, so I had to do something since I was scheduled for surgery the next day. I went to the emergency clinic and they gave me an amoxicillin, bromphen PSE DM, and magic mouth wash. I was given COVID-19, Flu, and Strep test which were negative. They indicated I had an ear infection in the left ear and  mucus was running down my sinus. My symptoms have not improved. I have surgery scheduled tomorrow and done.
I did not have an adverse reaction to the vaccine. I began having seasonal allergy symptoms and difficulty breathing in 03/2023. On a trip to a wedding, simply walking in an airport became difficult. I was diagnosed in 03/2023 with eosinophilic asthma. I now have two inhaler prescriptions to help me with my symptoms.
New onset left sided tinnitus; This is a spontaneous report from a non-contactable physician. A 53-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Mar2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On an unknown date in Apr2021, the patient experienced new onset left sided tinnitus. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event new onset left sided tinnitus was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
fever, chills, shivering, headached, body aches, joint aches, nausea
Foot and finger numbness, shortness of breath at times loss of memory, weakness and trouble walking.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 05-APR-2011, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) administered by a physician, as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain condition of herpes zoster. On or about 05-NOV-2016, the patient was treated by a physician for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as severe herpes zoster or shingles. The patient was prescribed VALTREX and BACTRIM in attempts to curb her painful symptoms. As a direct and proximate result of these malfunctions, 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. Additional information has been requested.
Pt recv vax 02Feb98 & 14Feb98 exp rash on stomach & cervical area & slight fever.
Painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult 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 pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age group was not reported but was captured as adult as per vaccine indication. The age at vaccination was not reported. The patient had received shingles vaccine and stated it was painful. The follow-up would not possible as no contact details were available.  This case had been linked with US2021AMR066116 and US2021AMR066117, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR066116:Father's case US-GLAXOSMITHKLINE-US2021AMR066117:Sister's case
AFTER VACCINE BEING ADMINISTERED AND WHILE PATIENT SITTING IN WAITING AREA HE BEGAN TO FEEL TINGLING IN BOTH HANDS. PATIENT WAS ALONE AND NO ONE ELSE WAS WITH HIM AT THIS TIME. THE PATIENTS VITAL SIGNS WERE NORMAL AND HE HAD NO OTHER COMPLAINTS AT THE TIME THE VITAL SIGNS WERE TAKEN. AFTER A HALF HOUR THE PATIENT STATED IT GOT A LITTLE BETTER AND HE FELT HE COULD DRIVE HOME. BEFORE I WOULD ALLOW HIM TO LEAVE I ASKED HIM TO DRIVE AROUND THE PARKING LOT TO MAKE SURE HE COULD DRIVE OK. HE DROVE VERY WELL AND WANTED TO GO HOME. THE PATIENT SIGNED AN RMA AND WHEN HE GOT HOME WE RECEIVED A PHONE CALL FROM HIS WIFE AT 11:40 PM STATED HE WAS HOME SAFE AND FEELING OK.
That night, after the vaccine, I had severe lower back spasms, really painful, but each did not last but a few seconds.  There were probably 3 or 4 of them, in succession. Other than sleeping for 48+ hours (except to eat) and a very sore arm vaccine site, and swollen (and still so, but improving), but no other events. No treatment except as given (Tylenol & ibuprofen), no other symptoms, etc.
pt ran t103 ax the noc following vax;pt was very limp, & still, eyes rolled back into head-mom called ER & was told to cont APAP & cool sponge bath
I had rapid heartbeat right after the vaccination and it happened for 6 hours. I called the doctor and they didn't give me any medicine or anything.
Diffuse swelling that is nontender, nonerythematous and no warmth on left upper arm.
Swelling, Rash, very sore, 4 inch diameter discolored circle on pt arm that was growing in size and warm to the touch. Went to Dr.
Symptoms started approximately 20 mins after administration, employee stated he felt general malaise , lightheaded, dizzy, nauseous, cold sweat, and was notably shivering. Employee was referred for occupational health clinic/ urgent facility for further care.
This spontaneous report was received from a physician via company representatives and from a support services director, refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 01-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ "2ml, 10 unit dose tube" and lot number K009752 with expiration date of 15-APR-2016, orally, which was stored at the lowest recorded temperature of 33 (0.555555556 Celsius degrees) for 72 hours and at the lowest recorded temperature of 34 (1.111111111 Celsius degrees) for 24 hours. The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested. Additional information has been requested.
Mother stated child was hyporesponsive after Prevnar (4 month shots) last time X 6 hours. NP spoke to mom, 4 hours, post vax, 6 month shots and he's doing fine.
At 1:00 pm on 1-25-2021 he stated he started feeling bad, bodyaches, headache, "sick feeling".  That night fever started 99*, still ha bodyaches, headache, chills.  On 1-26-2021 woke up with 101.7* temperature, took Tylenol 1000mg every 4-5 hours until it broke (approx 12 hours).  On 1-27-2021 fever down to 99* most of the day, no energy, headaches, bodyaches, "feel like a mack truck hit me" also reports "I could felt every broken bone that I have had" "that spot just hurt".  1/28/2021 reports that he is feeling some better, no fever, but still feels very tired and sore. Sent home from work today and encouraged to drink fluids, take Tylenol and rest.  Encouraged to talk to his PCP if symptoms continue to get worse.
Moderna COVID-19 Vaccine EUA  chills, fever 101.4, body aches, headache, stiff neck, fatigue
I conceived a pregnancy within 2 weeks of my vaccine which ultimately resulted in a miscarriage less than  6 weeks after the injection.
Severe lower back pain; This is a spontaneous report from a contactable healthcare professional (patient). A 54-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number Cc3248), via an unspecified route of administration in the left arm on 15Jan2021 at 13:15 at a single dose for COVID-19 immunization. Medical history included being tested for arthritis and allergies (unspecified). The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant at the time of vaccination. Concomitant medication included prednisone. The patient experienced severe lower back pain on 16Jan2021. The patient did not receive treatment for the event. The patient has not been tested for COVID-19 since the vaccination. Outcome of the event was not recovered.