chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax 9FEB82 & on 23FEB82 devel diabetic sx: excessive urination & thirst; parents did not recognize sx until pt went into coma 7APR92 following day pt died; pt was dehydrated w/early fecal impaction, pancreatic edema; cerebral edema
administered an undiluted dose of the Pfizer-BioNTech Covid-19 Vaccine to a patient; administered an undiluted dose of the Pfizer-BioNTech Covid-19 Vaccine to a patient; local reaction; This is a spontaneous report from a contactable nurse. A female patient of unspecified age received bnt162b2 (BNT162B2, lot number and expiry date were not reported) via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The nurse reported that one of their healthcare facilities administered an undiluted dose of the Pfizer-BioNTech Covid-19 Vaccine to a patient. She said she wants to know if there is going to be any more of an issue to the patient other than a local reaction. Outcome of the event local reaction was unknown.
mom states the day of shots pt cried for 3 hrs, which was uncontrollable; APAP was administered & pt was calm by late PM;
chills; uncontrollably shakes; nauseous; fatigue; That night started to vomit; fever (101 degree temp); shortness of breath; This is a spontaneous report from a contactable consumer (Patient). A 71-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Feb2021 17:00 (Batch/Lot Number: EN5138) as SINGLE DOSE for covid-19 immunisation. Medical history included heart Cond, RA (Rheumatoid arthritis) and allergies. The patient's concomitant medications included unspecified medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. First shot on 2/9 at 5pm. 24 hours later on 10Feb2021 05:00 PM chills, fever (101 degree temp), shortness of breath, uncontrollably shakes, nauseous, fatigue. Symptoms continued for the next 48 hrs and went to the local clinic. The patient was tested for covid and the flu. Both were negative. Prescribed nausea med. That night started to vomit and continued for the next 50 hours off and on. Fever broke at around 9 am on 2/15. The patient visited to emergency room/department or urgent care. Therapeutic measures were taken as a result of events. The outcome of the events were recovered on 2021.
Started to experience of shortness of breadth and pains in chest and back when trying to exercise.  Symptoms subsided if I set down and rested for a minute or two.  It has become less severe lately but is still occurring.  Just on November 9 I tried to some minor gardening and got the same symptoms.  I sat down foe a few minutes and completed my chores without an occurrence.  After 2nd vaccine back in February 2021, I didn't get the pain but did notice an increased heart rate when exercising.  Normal heart rate while walking was about 104, a week after the vaccine, my heart rate increased to about 118.  It went back to normal after a couple of months.  Then in June 2021 I was hospitalized with heart pains and 2 99%
Patient has been complaining of pain and soreness at the injection site for a longer period of time this year.
Pt was extremely anxious prior to injection. Pt experiences chest, nausea, extreme anxiety immediately post injection.  Immediate post injection symptoms and monitoring included pulse ox 99% for entirety of monitoring, BP 187/97 not typical for patient. 10 minutes into monitoring period, chest pain 6/10, BP  154/82.  15 minutes into monitoring CP 6/10, bp 167/84. Initiated EMS.  EMS Arrived at 12:30. Transported to ED
Patient stated that a few hours after receiving 1st dose of Pfizer vaccine, she started feeling chills, and fever. Patient is still experiencing fever symptoms. Patient stated fever has gotten worse. Patient stated that she has not seen doctor since vaccination.
Red, firm area approx 2 cm x 4 cm to right arm that is warm to touch
Starting 12/05/2022, in the evening, I started feeling achy and had a sore throat. It progressed the next few days to a sore throat and mucus. On 12/07/2022, I tested positive for COVID-19 with an at home test. That same day, I spoke to the doctor, who gave me info about quarantining and Paxlovid. I declined taking Paxlovid unless my symptoms worsened. Then, I had lots of mucus in my trachea causing me to become hoarse and lose my voice. Then, I finally started feeling better about a week later (12/12/2022). I can finally talk a little better now.
Pt recvd a dose of Engerix-B & devel a cramping sensation in the chest (similar to a spams), SOB, restlessness, extreme fatigue & an achy feeling all over late in the afternoon;
pt recv vax 19JUL95  w/other unspecified vax;later on 19JUL95 the area inferior to vax became red, swollen & tender;(no rxn in areas of other immunizations);
Underlying burning diminished and the psoriasis disappeared/did not had another episode of herpes again; Hadaches every now and then; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Underlying burning diminished and the psoriasis disappeared/did not had another episode of herpes again) and HEADACHE (Hadaches every now and then) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047b21a and 041b21a) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis (Always had psoriasis in her neck for 4 years) and Herpes infection (Used to get herpes in her lips or on her gluteus).   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Underlying burning diminished and the psoriasis disappeared/did not had another episode of herpes again) and HEADACHE (Hadaches every now and then). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Underlying burning diminished and the psoriasis disappeared/did not had another episode of herpes again) and HEADACHE (Hadaches every now and then) outcome was unknown.            No concomitant medication were reported. It was reported that 3 days after receiving the vaccine her underlying burning diminished and the psoriasis disappeared.Patient also stated that sometimes she used to get herpes in her lips or on her gluteus and after vaccination she didn't had another episode of herpes again.
pt recv vax & the next day devel an inj site rxn characterized by induration, warmth, redness & tenderness;tx w/Ibuprofen & applications of ice;
felt a little tired; felt drowsy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "felt a little tired"; SOMNOLENCE (non-serious), outcome "unknown", described as "felt drowsy".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On March 22 2021, I had leg cramps that felt like Charlie horses, I had a fever of 102 and I missed work. On March 24 I went to my doctor because my legs were still bothering me. That same night I ended up experiencing extreme dizzy spells, I fainted. On March 25 called my doctor I told them my symptoms were getting worse, the office made me a follow up appointment for April 2 for dizzy spells and fatigue. My symptoms continued to get worse, I had a tele visit April 5. Then, I started developing a dry cough. I called again that same day 4/5 for shortness of breath and went in to my doctors office 1:10pm. They did a chest xray. April 6th I had another tele appointment for anxiety Because I started developing anxiety from all my symptoms. April 7th I called again I had blood in my urine and back pain, It was very alarming because my last period was & years ago. April 7th I went to an Urgent Care . April 8th it got really bad. I went emergency room, I felt like I had a lump in my throat and experiencing some chest tightness, my pulse was 101 beats per minute, heart 118, BP was 143/106 I presented with unspecified Right Bundle Branch block and I ended up tachycardia,  they did a CT scan of my chest. the doctor gave me Valium & Hydroxyzine.  At the hospital I started dry heaving and vomiting. April 9th saw a new doctor still very nauseated and I was experienced nausea and heart palpitations, and rapid heart.
Numbness in area of injection and sharp shooting pain and increased, prolonged numbness in upper arm when raised overhead. Symptoms ongoing and increasing at this time (10/3/2016). Also, aching in injection location and headache experienced on day 1 after flu shot (same as last year). Note: Flu shot mandatory for continued employment.
mom states pt irritable during noc p/vax, thought was teething ran fever 100 & was given APAP x 2; better in AM but irritable; 14MAY92 eyes rolled back in head & was stiff for a few seconds;
This spontaneous report was received from a female patient of approximately 78 years. The patient had drug reactions or allergies to celecoxib (CELEBREX), nitrofurantoin, ciprofloxacine, "Sulfa" and alendronate. The patient's concomitant therapies included levocetirizine dihydrochloride (XYZAL) and "many other medications". On an unknown date, in 2012, the patient was vaccinated with an unspecified "pneumonia shot" (manufacturer unknown) for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unknown date, in 2012, on the arm she received the "pneumonia shot" (manufacturer unknown) became red and swollen (peripheral swelling and erythema). Then, on an unknown date, one week after receiving the "pneumonia shot" (manufacturer unknown), she experienced unspecified "breathing problems" and went later, on an unknown date to  an unspecified emergency room for the "breathing problems" and was diagnosed with pneumonia but was not admitted to the hospital. The patient recovered from the event on an unspecified date in 2012. On an unknown date, reported as "few years ago", the patient started therapy with mometasone furoate(ASMANEX TWISTHALER) 200 micrograms, via respiratory for chronic bronchitis (dose, frequency, lot number and expiration date were not reported). On an unknown date, in November 2018, reported as last week, the patient she took "5 doses"  of mometasone furoate(ASMANEX TWISTHALER) 200micrograms, per respiratory, with lot # R022733 with expiration date on 30-NOV-2019 with a dose counter malfunction (product quality issue) (dose and frequency were not reported) and then experienced coughing "in the mornings". At the time of this report, the patient was recovering from the event cough with a different mometasone furoate (ASMANEX TWISTHALER) (dose, frequency,  lot number and expiration date were not reported) that was started on 01-DEC-2018. The outcome of the events peripheral swelling and erythema and the causal relationship between the aforementioned events and both suspect therapies were not reported. Upon internal review, the event pneumonia was considered to be medically significant.; Sender's Comments:  US-009507513-1812USA002765:
pain at injection site; redness at injection site; This case was reported by a consumer and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th January 2023, the patient received the 1st dose of Shingrix (intramuscular). On 5th January 2023, less than a day after receiving Shingrix, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.     Additional Information: GSK receipt date: 09-JAN-2023 Reporters comment: The reporter reported that patient received the first dose of shingrix vaccine and experienced injection site pain and injection site redness. The reporter did not consent to follow up.; Sender's Comments:  US-GSK-US2023002199:same reporter
This initial spontaneous case, received on 20-Oct-2017, reported by other non-health professional and concerning a 32-year-old male patient. Patient's medical history and concomitant medications was not reported. On 18-Oct-2017, the patient received FLUAD (dose: 0.5 ml, route of administration, anatomical location, batch number: 179403, expiry date: Jun-2018). It was reported that 32-year-old male patient received FLUAD (explicitly coded as inappropriate age at vaccine administration). No other symptoms were experienced by the patient so far. Outcome of the event was not reported. The reporter assessed this case non-serious.
Arm soreness at injections site, 1st dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 (Lot number: EW0150) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis in her knees" (unspecified if ongoing), notes: Diagnosed about 5 years ago. Concomitant medication(s) included: ALEVE taken for headache.  The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Arm soreness at injections site, 1st dose".  Additional Information: Patient did not received Prior Vaccinations within 4 weeks. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available):  No, she has had vaccines before but, she is not sure if they were Pfizer. Caller reports she takes some times when she gets headaches but, other that medication, nothing else. The headaches are not related to the vaccine per the caller. 1st dose NDC, Lot and Expiration: EW0150; patient got it in the left arm. A friend of the callers husband said anecdotally, that the patient should get the injections in the opposite arms.  No follow-up attempts are possible. No further information is expected.
Developed fever, chills, headache, nausea and left cervical and subclavicular lymphadenopathy; feeling weak and generally fatigued - developed elevated liver enzymes & TSH, pancytopenia, and anorexia over the course of 2 months. Onset of initial symptoms was 2 days s/p smallpox and 7 days s/p anthrax #3. Medical records reviewed. Please add COSTARTS of PANCYTOPENIA and ANOREXIA.
Approximately 12 hours post vax the patient developed joint pain, muscle aches, and a mild sore throat. These symptoms resolved in 24 hours without treatment.
Psoriatic arthritis aggravated/ General body pain/body soreness; Vaccination site pain/soreness in ijection site; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated/ General body pain/body soreness), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain/soreness in ijection site) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated/ General body pain/body soreness), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain/soreness in ijection site). At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated/ General body pain/body soreness) had not resolved and FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain/soreness in ijection site) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported.  The patient experienced vaccine caused fatigue for a day, soreness in injection site, body soreness and occasional psoriatic arthritis flare up. The daily dose of SPIKEVAX was reported as 1 in 1 once. It was unknown if patient was enrolled in a COVID-19 Vaccine trial.  No treatment medications were reported.
lump near injection site (vaccine was injected toward anterior/lateral not in normal muscle site) entire right arm in pain right thigh pain, right ankle pain and swelling lower back pain loss of smell, taste, nausea, diarrhea right sided joint pain extreme fatique
Headache; Chills; Tired; This is a spontaneous report from a contactable consumer (patient). A 59-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 18Feb2021 at 14:15(at the age of 59-year-old) as dose number unknown,single for COVID-19 immunisation. Medical history included diabetes. Concomitant medications included insulin detemir (LEVEMIR), insulin aspart (NOVOLOG) taken for an unspecified indication. Patient had no known allergies. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination. On 19Feb2021 at 10:00 the patient experienced headache, chills, tired. Reporter stated that the events was not severe but has continued to escalate as day is going on. Patient not received treatment for the events. Since the vaccination the Patient had not been diagnosed with COVID-19. Outcome of the events was unknown.  Information about lot/Batch number has been requested.  Follow-up (14MAY2021): Follow-up attempts completed. No further information expected.
paralysis on left one side of the face, difficulty in closing eyelids and smiling, drooling, difficulty in chewing  numbness of tongue, Headache
Soreness first and then diagnosed with Bells Palsy. Left side of the face paralyzed. Cannot keep left eye lid closed  Being treated with Prednisone, Acyclovir and eye drops and eye ointment
chemical taste in mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (chemical taste in mouth) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included Hypertension (Taking medications) since an unknown date.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (chemical taste in mouth). At the time of the report, DYSGEUSIA (chemical taste in mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided. No treatment information provided.    Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: NNI On 20-Apr-2021: NNI
Shortness of breath, initially with exertion. Progressive to dyspnea at rest, pulmonary emboli, right heart failure.
STARTING ON 16 FEB 2021 Through today (20 Feb).  Bad flu symptoms.  Headaches - from low to severe.  Body aches from low to severe.  Joint aches from low to severe.  Severe chills.  Severe sweating - soaking the bed nightly.  Fever - Tends to be lower in AM - 99.0.  During afternoon and night 102.5. Unable to perform any normal daily work or activities.
Titers for measles were negative; Sarcoidosis on an unspecified date in 2007; This spontaneous report was received from a Nurse Prescriber, referring to a 30 year old male patient. Information regarding the patient's pertinent medical history, concurrent conditions and known allergies was not provided. The patient stated that he was on "23 other unspecified medications" and infliximab-dyyb (INFLECTRA) as concomitant therapies.     On an unknown date (reported as "when he was younger"), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), diluted on sterile diluent (MERCK STERILE DILUENT) (strength, route of vaccination, lot # and expiration date were not provided) as routine vaccination.          In 2007, the patient developed sarcoidosis. It was reported that, the patient was treated on unspecified dates with methotrexate, and at the reporting time, is on therapy with infliximab-dyyb (INFLECTRA) which was started on an unspecified date. It was also reported that, on an unknown date, the patient titers for measles were negative (measles antibody negative).      At the time of the report, the outcome of sarcoidosis was reported as recovering and the outcome of measles antibody negative was unknown. The causality between the adverse events and vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not provided.        Upon internal review, sarcoidosis was determined to be medically significant.
I had my vaccination on 10/19/2022. On 11/17/2022 I started to have heart palpitations on a regular basis. In 12/2022 I went to the emergency room. I was informed that I was ok and was prescribed beta blockers and phlebotomine. I am currently feeling better.
(R) upper arm was slightly swollen & pink surrounding site of injection (yellow fever).  C/o itching over body but no hives (Reported 7/31/09 - advised to check with her MD).
States the next day noticed soreness but deep soreness. Still experiencing this. No red areas. Range of motion isn't limited.  States it didn't hurt at time of injection and doesn't limit his activities. He states it hurts more internally not externally.  Did advise to see his primary doctor.
She was shaking, she thought she was having a seizure with how bad she was shaking; She was shaking, she thought she was having a seizure with how bad she was shaking; Chills; Fever; sore hands and wrists; sore hands and wrists; totally exhausted; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 01Apr2021 15:00 (Lot Number: EPT533) as single dose for covid-19 immunisation. The patient previously took flu shot.  Medical history included diabeticc, thyroid is done, real bad psoriasis, high blood pressure, triglycerides, cholesterol , anxiety, to replenish potassium. Concomitant medications included metoprolol taken for hypertension; acetylsalicylic acid (ASPIRIN (E.C.)); citalopram taken for anxiety; amlodipine taken for blood pressure; hydrochlorothiazide; fenofibrate taken for blood triglycerides; atorvastatin taken for blood cholesterol; losartan potassium to replenish potassium; colecalciferol (VITAMIN D3); metformin taken for diabetes mellitus; levothyroxine; hydroxyzine; guselkumab (TREMFYA) taken for psoriasis,.  The patient was shaking, she thought she was having a seizure with how bad she was shaking, chills, fever, sore hands and wrists, totally exhausted, diarrhea on 01Apr2021.  The outcome of events chills, Wrist pain, Pain in hand was recovered on 05Apr2021; The outcome of event Fever and Diarrhea was recovered on 06Apr2021; outcome of other events was recovering.