chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Per pharmacy notes, patient had an immediate reaction (within 2 minutes) of facial flushing, chest pain, feeling faint. She also had pain from her head down to her tail point. EMT came and did an evaluation. She was cleared to go home. Patient came to our office for an evaluation. Dr. sent her home after her evaluation. No itching or hives. She denied tongue or throat swelling.
got Shingles behind my ear; Incomplete course of vaccination; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 8-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the first shot when they started them and got them behind his/her ear. The patient stated that guess who got shingles last year.  Additional supportive information: Till the time of reporting, the patient did not receive second shot of Shingles vaccine, which led to incomplete course of vaccination. The case was processed in worst approach as it reported that the patient received the shot when they start them which seem the reporter wanted to say when GlaxoSmithKline started at that time patient got the shot, therefore suspect was coded as Shingles vaccine as generic vaccine. 2nd shot was also coded as suspect with event incomplete course of vaccination as GlaxoSmithKline had market vaccine in October 2017 (patient got the vaccine) and the recommended interval between doses were already passed and even outcome of event was unknown which was occurred with first shot.
A few days after my 2nd vaccine, I felt congestion/blockage in my ears. I assumed it was a cold and not related but it never got better. I noticed higher pitched/garbled sounds in my left ear; and there was a constant whooshing sound. I went to my primary care doctor who referred me to an ENT. The ENT checked my ears and sent me to an audiologist who confirmed I had lost hearing in the bass frequency in my left ear. Structurally the ear anatomy is fine so ENT sent me for an MRI, which ruled-out acoustic neuroma. ENT said it is neurological and we don't know why it happened. Because of the timing, I believe it is related to the COVID-19 vaccine.
Shortly after the shot I began to feel itchiness in my right eye through out the day.  The next day 2/13/21  I woke up with blood in my right eye.  I did not have any itchiness, pain, or teary eye.  On 2/14/21 the blood now was in 75%  of my right eye.  Today on 2/15/21 I went to urgent care to have it checked out and they told me I had a ruptured blood vessel.  My entire eye  is now covered in blood.  I had not experienced any vomiting or had any cough of any type, or hit my eye anywhere for this to happen.
pt recvd vax & w/in several days devel rash on arms & legs; no other info available @ this time;
I contracted a respiratory virus HMPV. I was hospitalized in ICU for five days and then went home.
9/19/21 Exhausted, nausea,weak, headache, body aches,  shortness  of breath worse with exertion , headache  9/20-9/21 Missed work due to weakness, muscle aches, loss of voice, wheezing, shortness of breath worse with exertion , headaches   9/22-9/23 hoarse voice, tired, wheezing, shortness of breath continues especially with exertion , headaches - now evening sore throat with burning  in chest and left ear burn/pain/hurting No sign 9/22-9/23 symptoms will ease.  Instructed by co-workers (I am a Registered Nurse) to report these issues  to you
Patient came in 2 days after vaccine with red swollen injection site reaction on the right arm. Rph consulted package insert to which this was a normal expected adverse event, and informed patient to let us know if not improved within 1 week. Patient came in 3/14/18 (1 week after vaccination) and said the arm reaction was gone, but had large red itchy lesions on her forehead and scalp. Informed patient to seek medical care from her doctor.
Symmetric petechial rash noted to bilateral medial upper arms; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 5-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2022 as dose 1, single (Lot number: FL8094) at the age of 5 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PETECHIAE (non-serious) with onset 12Apr2022, outcome "recovering", described as "Symmetric petechial rash noted to bilateral medial upper arms". The event "symmetric petechial rash noted to bilateral medial upper arms" required physician office visit. Therapeutic measures were not taken as a result of petechiae.  Additional Information: Patient did not had covid prior vaccination and was not tested for covid post vaccination.
Flu shot, pt noted area of redness over major portion of upper arm including injection site. Described as "flat pink, non-tender but itchy", warm. Cleared up by 1 week later. On 11/22/2001 pt diagnosed with flu and noticed that red spot on arm had returned, then disappeared.
STINGING; RIGHT (SHOT ARM) BEGAN TO ACHE; BURNING PAIN IN NECK; NUMBNESS FACIAL; TINGLING IN HANDS AND FEET; SWOLLEN LYMPH NODE; SORE THROAT; RIGHT EYE WATERS; RUNNY NOSE; RIGHT SIDE FEELS NUMB; HOT LEFT FOOT; BURNING PAIN IN LOWER BACK; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced numbness facial. On APR-2021, the subject experienced tingling in hands and feet. On APR-2021, the subject experienced swollen lymph node. On APR-2021, the subject experienced sore throat. On APR-2021, the subject experienced right eye waters. On APR-2021, the subject experienced runny nose. On APR-2021, the subject experienced right side feels numb. On APR-2021, the subject experienced hot left foot. On APR-2021, the subject experienced burning pain in lower back. On APR-2021, the subject experienced fatigue. Treatment medications included: menthol. On 07-APR-2021, the subject experienced stinging. On 07-APR-2021, the subject experienced right (shot arm) began to ache. On 07-APR-2021, the subject experienced burning pain in neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning pain in neck, and burning pain in lower back, and the outcome of stinging, right (shot arm) began to ache, numbness facial, tingling in hands and feet, swollen lymph node, sore throat, right eye waters, runny nose, fatigue, right side feels numb and hot left foot was not reported. This report was non-serious.
COULD NOT STAND; FEEL CRAZY; CHILLS; LEG PAIN SO BAD; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced could not stand, feel crazy, chills, leg pain so bad, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not stand, and leg pain so bad, and the outcome of chills, fever and feel crazy was not reported. This report was non-serious.
Shortly after receiving injections patient complained of dizziness, nausea and sweating. She requested and was given water. Patient was offered a dose of benadryl but refused (it was explained that it would help if this was an allergic reaction). Patient also refused EMT services. After about 40 minutes the patient reported feeling much better and the symptoms had subsided. Management took down relevent information pertaining to the incident and will follow up tomorrow with patient. Patient was also instructed to follow up with pharmacy if symptoms re-occurred or worsened and to seek medical attention.
patient felt fine for several hours.  About bedtime his arm began to swell up and was red and painful for about 1.5 days.  Then his arms had a rash with small red bumps that also lasted about 1.5 days.  Once this subsided he reports difficulty breathing and a persistent cough that has lasted the 2 days since the rash resolved.  Just now after 5 days he reports that he is feeling better.
Fever over 101 for 2 days,  Cold Chills,  hallucinations, Muscle and Joint pain. Vomiting and Diarrhea (6 weeks and counting), Suicidal and Homicidal ( thoughts(4 weeks), Extreme fatigue (6 weeks and counting), Confusion  and runny nose (6 weeks and counting)
Armpit area was swollen; I noticed discomfort in my armpit area/ It was sore; The patient received third (booster) dose of BNT162b2; This is a spontaneous report from a contactable other healthcare professional, the patient. A 47-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2593) via intramuscular route of administration in the right arm on 12Nov2021 at 17:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient did not receive any other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1686) via intramuscular route of administration in the right arm on 08Jan2021 at 12:00 (at the age of 46-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265) via intramuscular route of administration in the right arm on 29Jan2021 at 12:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient reported that after her vaccine on 12Nov2021 evening, she felt great. On 13Nov2021 morning and early afternoon no side effects. On the same day at 18:00, early evening, the patient noticed discomfort in her armpit area. It was swollen and sore and on 14Nov2021 morning it still was. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event discomfort in her armpit area, it was swollen and sore was resolving at the time of this report.
PATIENT CAME BACK ON 8/20/21 AFTER RECEVING COVID-19 VACCINE ON 8/17/2021. SHE HAS A RED, WARM, FIRM  WELT ON LEFT ARM IN THE TRICEPS AREA. SHE REPORTS IT IS WHERE THE VACCINE WAS GIVEN.
Patient was given a moderna vaccine that was given 46 hours after vial was punctured. Trying to reach patient to inform and reschedule to be re-vaccinated. Per manufacture patient should be re-vaccinated due to lack of efficacious.
Interchange of vaccine products; Tested positive for covid; Tested positive for covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 87-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 at 02:00 as dose number unknown (booster), single (Lot number: HG4628, Expiration Date: 25Nov2023) at the age of 87 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (ongoing); "thyroid problems" (ongoing); "heart problems" (ongoing). Concomitant medication(s) included: LOSARTAN POTASSIUM oral taken for hypertension (ongoing); LEVOTHYROXINE oral taken for thyroid disorder (ongoing); PRAVASTATIN oral taken for cardiac disorder (ongoing). Vaccination history included: bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE, Batch/Lot number: SM0698, Anatomical location: Arm left), administration date: 30Jun2022, for COVID-19 Immunisation; bnt162b2;bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE, Batch/Lot number: GH9693, Anatomical location: Arm left), administration date: 08Oct2022, for COVID-19 Immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Sep2023, outcome "unknown" and all described as "Tested positive for covid"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The event "tested positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Sep2023) Positive. Therapeutic measures (Paxlovid treatment) were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300309636 same patient, different event;
The area around my eyes turned red and puffed up for at least 48 hours. I have never had Botox or any other injections around my eyes. This happened after the first dose, also.
1:15 Patient left the building  after 15 minute wait ,went to eat.   Felt chest and throat tightness and burning.  Came back to COVID vaccine clinic.  Also reported a headache.  PSO2 100 %Pulse 72  b/p 128/82, crying ,face red.  Skin pink warm and dry. Respirations even and unlabored.  Informed her that her vital signs are stable , she can be taken to ER.  Wanted to wait and be monitored here.   1:25  PSO2 99%  pulse70    calming down called mother to talk.    1:37 PSO2 97% pulse 78 reports chest and throat tightness 1:42 Still reports throat and chest tightness.  B/P 132/84  Pulse 76 PSO2 98  does not want to go the ER wants to  go home.  Informed to go to ER for any shortness of breath or further problems.
Patient received her vaccine and began complaining of a headache and C/O pressure in the back of her neck. Stated has hypertension and did not take her medications. Also she had weakness in lower legs after walking to observation area. Participant asked to be transported to the hospital.
Patient's wife stated that the patient had swelling on the injection arm to above the elbow which required a visit to a med express. The injection location was red and swollen and hot to the touch.
This spontaneous report was received from a Registered Nurse refers to a 1 year old patient(gender unknown). No medical history was reported. On 07-JUN-2013, the patient was vaccinated with a dose of PROQUAD (Merck) (instead of M-M-R II)(lot #, expiry not reported). On 07-JUN-2013, the patient was concomitantly vaccinated with VARIVAX (Merck) (lot #, expiry not reported). On 07-JUN-2013, the medication error occurred as the person who administered the PROQUAD was not familiar with the PROQUAD and saw measles, mumps, rubella on the PROQUAD label and thought the PROQUAD was M-M-R II. No adverse event reported. Additional information is not expected.
This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 29-JUL-2016, the patient was vaccinated with improperly stored dose of PROQUAD (dose, route of administration and injection site were not provided) (lot # M004892, expiration date: 25-JUL-2017). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
hives today on neck and face/2 hives on face and neck; felt her cheeks getting tight, red, and hot; felt her cheeks getting tight, red, and hot; felt her cheeks getting tight, red, and hot; Same as 1st/Metallic taste in mouth; same as 1st/extra salivating; taste metallic; nausea; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives today on neck and face/2 hives on face and neck), SWELLING FACE (felt her cheeks getting tight, red, and hot), ERYTHEMA (felt her cheeks getting tight, red, and hot), HOT FLUSH (felt her cheeks getting tight, red, and hot) and DYSGEUSIA (Same as 1st/Metallic taste in mouth) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042821A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product CHLORMEZANONE (RESTORIL [CHLORMEZANONE]) for an unknown indication.    Previously administered products included for an unreported indication: SHINGRIX (fever 100.4 for 4 days) on 15-Oct-2020. Concurrent medical conditions included Urticaria. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-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 started CHLORMEZANONE (RESTORIL [CHLORMEZANONE]) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced URTICARIA (hives today on neck and face/2 hives on face and neck), SWELLING FACE (felt her cheeks getting tight, red, and hot), ERYTHEMA (felt her cheeks getting tight, red, and hot), HOT FLUSH (felt her cheeks getting tight, red, and hot), DYSGEUSIA (Same as 1st/Metallic taste in mouth), SALIVARY HYPERSECRETION (same as 1st/extra salivating), DYSGEUSIA (taste metallic) and NAUSEA (nausea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) 19-Apr-2021 for Antihistamine therapy, at a dose of 25 mg and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, URTICARIA (hives today on neck and face/2 hives on face and neck), SWELLING FACE (felt her cheeks getting tight, red, and hot), ERYTHEMA (felt her cheeks getting tight, red, and hot), HOT FLUSH (felt her cheeks getting tight, red, and hot), DYSGEUSIA (Same as 1st/Metallic taste in mouth), SALIVARY HYPERSECRETION (same as 1st/extra salivating), DYSGEUSIA (taste metallic) and NAUSEA (nausea) had resolved.            This case was linked to MOD-2021-080179, MOD-2021-080179 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: follow up was received on 24 may 2021 contact information, patient demographics,  date and new events of the second dose, patient concomitant medication,  and event outcome was updated
No additional AE; patient was administered improperly stored PNEUMOVAX23; This spontaneous report was received from an office manager, concerning a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-DEC-2022, a pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was improperly stored at a temperature of 55 degrees Fahrenheit for 153 hours. There were no previous temperature excursions. On 04-JAN-2023, the patient was vaccinated with the improperly stored (Product storage error) dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (Lot #W007035, expiration date reported as 23-OCT-2023, but upon internal validation stablished as 20-OCT-2023, administered for prophylaxis (strength, anatomical location and route of administration were not provided). No additional adverse events were reported.   This is one of several reports from the same reporter.  ; Sender's Comments:  US-009507513-2301USA007635: US-009507513-2301USA007605: US-009507513-2301USA007405: US-009507513-2301USA007693: US-009507513-2301USA007699:
HX OF COVID AFTER VACCINATION; PATIENT EXPIRED ON 11/03/2021
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 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. 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.