chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles; This non-serious 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-Mar-2023. The patient reported this case via interactive digital media. The reporter stated that he/she know 2 people that got Shingles right after they got the Shingles shot. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR067374:Same reporter
She has not had her period since Aug 16, 2021 - nearly 90 days since her last cycle
COULD NOT EAT; MUSCLE ACHE; HIGH FEVER 101.1; HEAVY LEGS; TEETH CHATTERING; COUGH; LIGHT HEADED; HEADACHE; This spontaneous report received from a patient 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: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 02-APR-2021, the subject experienced heavy legs. On 02-APR-2021, the subject experienced teeth chattering. On 02-APR-2021, the subject experienced cough. On 02-APR-2021, the subject experienced light headed. On 02-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced high fever 101.1. Laboratory data included: Body temperature (NR: not provided) 101.1 high fever. On 03-APR-2021, the subject experienced could not eat. On 03-APR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from teeth chattering on APR-2021, and headache, and high fever 101.1 on 05-APR-2021, was recovering from heavy legs, could not eat, and cough, and had not recovered from muscle ache, and light headed. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the cases is assessed non serious.
Headache, eye pain, dizziness. Headache started Saturday night 4/17/21. Woke up on 4/18/21 and was dizzy and had bad Headache.  It progressed all day and the Headache was relieved by taking Aleve (2) around 5:30 pm. The dizziness is still happening as of today 4/20/21 and Headache came back. Took Aleve again and Headache subsided but dizzy still. Almost like I have vertigo.
Received Smallpox vaccine on 13JUL2009, on 6AUG2009 I had 2 Blisters pop up. I had Immunizations verifiy that the smallpox spread.
body ache; Chills; Low fever; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown (as reported: "EK5230 or EK5730, it could 52 or 57, I am not sure, that may be 5730"), via an unspecified route of administration on 14Jan2021 at single dose for Covid-19 immunization. There were no medical history and concomitant medications. The patient reported some side effects from the COVID vaccine. The patient reported she had 3 days (as reported-pending clarification) of really bad body ache, chills, low fever, and fatigue from 14Jan2021. The patient received "Flu syrup" as treatment for the adverse events. The outcome of events was not recovered (as reported "still experiencing"-pending clarification).  Information about lot/batch number has been requested.
Initial NP evaluation for facial swelling. VS: 147/94, 122, 99%, HEENT: hives noted on face, and bilateral arms. No facial edema noted, oropharynx wnl, Lungs: cta, CV: tachycardic Benadryl 25 mg po given @ 1159 At 1212 pt noted with extension of hives onto her chest, also noted with facial edema extending to ears. Also now c/o throat tightness, now with post pharygnx edema. VS: 137/88, 118, 99% Ambulance called, Epi pen injected @ 1213, Vs 12:21, 136/76, 142, 100%  Post dose noted with reduction in hives and facial edema. Still with c/o throat tightness but no edema noted.  Care transferred to ambulance crew.
By Friday afternoon Pt arm was swollen with fluid Saturday it was swollen to wrist. Red somewhat and tender called hospital referred to PMP. Spoke with Dr who suggested Benadryl and Tylenol and elevation of arm. Pt cannot take Benadryl but took Tylenol 2 tab Q 4 hours. Is too busy to elevate arm. By Monday arm much better, will go to PMD on Tuesday if not 100% improved.
I got my second shot 2 days after the spotting increased along with some clotting; spotting increased along with some clotting; Light Period; I am noticing some weakness and Dark circles around my Eyes; I am noticing some weakness and Dark circles around my Eyes; This is a spontaneous report from a contactable consumer. A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FC3181 and expiration date was not reported), intramuscular, administered in Arm Left on 28Aug2021 12:00 at dose 2, single for covid-19 immunization. Medical history included ongoing HEPC (hepatitis c), ongoing asthma, only shows up during allergy season and patient had this since childhood; she had been post-menopausal for 6 years. Family Medical History was none. Concomitant medications included All day allergy relief for Allergies from 01Sep2021 to 03Sep2021. Patient did not receive any other vaccines prior to the COVID vaccine. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was FA7584 and expiration date was not reported) on 07Aug2021 16:00 intramuscularly in left arm at dose 1, single for covid-19 immunization and experienced post-menopausal bleeding for 4 weeks. 2 days after second dose, patient's spotting increased along with some clotting, It has been 4 weeks at the time of report and she was still spotting to the point of a high period and no treatment was taken. Because of this she would be seeing a doctor. She also has noticed some weakness and dark circles around eyes. She wish she had known about this before the shot. The most recent vaccine was administered at Pharmacy or Drug store. The outcome of the events weakness and dark circles around Eyes was unknown and outcome of rest of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Patient lost consciousness and then had seizure activity with myoclonic jerking and eye twitching for about 5-10 seconds. No incontinence. Patient's heart rate was 46 post seizure and returned to normal range within a few minutes.
@1045 Nurse was called to the hallway because pt was feeling tachycardic. C/O dizziness, SOB, tachycardia with rate of 100s+     Upon seeing pt, he reported that the HR is better. C/O feeling hot, dizzy, numbness and weakness to bilat hands, SOB. Resp even and unlabored. RR22. VS 170/95 (110) 59 98%. Team alert was initially called but pt refused to go to the ED. Team alert cancelled. Pt wants to rest and wait it out. Assisted back to room. Pt ambulated with supervision and support of RN. Pt refused to use the wheelchair. Water provided. Pt was able to ambulate towards to room without any difficulties. Able to speak in full sentences.      @VS 1117 VS 150/89 59. Pt's symptoms are starting to get better. Dizziness is really mild. Denies SOB. Slightly better numbness and weakness to hands. Instructed to increase fluid intake.      @1125 VS 140/92 (107) 60 97%RA. Pt is feeling better. Denies dizziness, tingling to hands. C/O mild weakness to hands but able to move it better than initial encounter. Pt stated that he wishes to leave, go to cafeteria and eat. Pt is confident of going home. Pt has a ride home, mother will drive him home. Checked with the Dr. Per MD, okay to go home. Encourage pt to follow up with PMD and to go to the ED for new symptoms or worsening symptoms. Pt verbalized understanding.      @1142 VS 151/82 (109) 61 Pt stood up. Feeling better. Gait stable. Denies any dizziness. Mild weakness to bilat hands. No sob noted. No s/sx of distress noted. Resp even and unlabored.
pt recv vax 18SEP96 & 2 days later 20SEP96 pt exp lymph node swelling in the lt submadibular & supraclavicular area;this lasted four days;pt also reported two days prior to vax exp canker sore on lt side of mouth;
Pfizer COVID-19 Vaccine EUA  3/2: Pt received Pfizer vaccine 2/26/2021 and started feeling progressively worse - endorsed fever, diarrhea, body aches, trouble breathing, lack of appetite. On 3/2/2021 pt and husband presented to ED. Pt's husband stated that pt had become more and more confused since she received the vaccine and that on 3/2 she could not complete her sentences. Temp 101.6 on arrival, tachycardic in 130s, tachypneic in 120s, but not hypoxic. Patient was given acetaminophen on arrival. IV was inserted and patient was given 1 L intravenous fluid replacement as well as 2 g ceftriaxone for broad-spectrum coverage within 3 hours of arrival. Blood work was drawn that shows no leukocytosis but lactic acidosis to 3.3.  There are multiple electrolyte abnormalities, hyponatremia 127, hypokalemia 2.8, creatinine 1.01, ALT 59 AST 53, ALP 136, total bili 1.3, lactic acidosis 3.3, troponin 0.02. Patient was given 40 mEq of oral potassium.  Additional L of normal saline was given for total of 2 L normal saline bolus.  Chest x-ray shows right basilar pneumonia. Also shows pulmonary nodule of which husband was made aware. LFTs are noted be elevated, so biliary ultrasound was obtained that was negative with limit to body habitus. Husband was updated. Azithromycin was added on. Rapid COVID antigen was negative.  3/3/21: Febrile, SOB overnight. Pt more lethargic, trailing off in the middle of sentences and having difficulties following conversation. Continue sepsis protocol, add vancomycin IV to ceftriaxone and azithromycin. Frequent neuro checks. MRCP. Chest pain-free, serial cardiac enzymes from yesterday to demonstrate nonischemic pattern likely type 2 NSTEMI. 2/2 blood cultures from 3/2 positive for Streptococcus pyogenes (Group A). Vancomycin and azithromycin dc'd.  3/11: Discharged from hospital. Patient admitted for acute hypoxic respiratory failure secondary to right basilar community-acquired pneumonia.  Blood culture grew Streptococcus pyogenes, patient was initially treated with ceftriaxone and switched to Ancef . repeat blood culture on 03/04/2021 showed no growth. Patient will complete a total 14 day course of antibiotics with amoxicillin from culture negative date. Patient had right-sided pleural effusion, pulmonary consulted and she underwent thoracentesis x2 culture showed no growth, considered parapneumonic effusion.  Patient required 2 L continuous oxygen and deemed stable for discharge.  She will follow up with Pulmonary in 3 weeks, outpatient chest CT in 4-6 weeks to be ordered by Pulmonary to assess lung nodule and known thoracic aortic aneurysm.   PTOT recommended home discharge with VNA. On discharge patient was a febrile and hemodynamically stable. Remained COVID negative throughout.
Developed migrating episodic wrist, finger hand shoulder hips and knee pain, finger numbness 7 days after receipt of rabies #2 and anthrax #3. Diagnosis Feb 2017 Palindromic rheumatism. Serology shows (+) RF and (+) CCP prior to vaccine receipt.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 16-FEB-2016, the patient was vaccinated with improperly stored oral ROTATEQ, 2ml, once (dose number was not provided) lot # L013206, expiry date 29-JAN-2017. No adverse effects were reported. Temperature excursion was noted as 57 Fahrenheit for 71 hours and 45 minutes, there was no previous temperature excursion. This is one of two reports received from the same reporter. Additional information has been requested.
Pt received 2 vaccines on 3/6/02-came into our clinic @ 2040 on 3/8/02 with c/o right arm with redness (allergic reaction vs infection) and swelling. Treated with Keflex and Benadryl. Several CM of erythema and induration.
Eight days after vaccination, right upper area of injection became red and itchy, progression to swollen, painful and warm.   Area of redness approximately 4" x 3".   This is the third day, pain and swelling have decreased but new onset of extreme fatigue .  There had been nothing unusual  until the eight day.
Had ringing in both ears that was intermittent/ The ringing became constant; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Had ringing in both ears that was intermittent/ The ringing became constant) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Fatigue and Ringing in ears.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced TINNITUS (Had ringing in both ears that was intermittent/ The ringing became constant). At the time of the report, TINNITUS (Had ringing in both ears that was intermittent/ The ringing became constant) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable.  No Concomitant medication were reported.  No treatment medication were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-109561 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-109561:Second Dose Case
Patient requested a Pfizer Covid vaccine from the foot team nurses, RN and RN on 06/29/2022.  The client said he had received 1 Janssen and 1 Pfizer vaccine in 2021 while living elsewhere.  He did not have a record of his previous vaccinations and said he was unable to obtain the documentation.  The client denied having a history of allergies. He reported a history of anxiety, anemia, COPD, asthma, and ulcers.  The client said he experienced shortness of breath one minute after receiving the Janssen vaccine.  He said the shortness of breath resolved ?quickly? and he was fine for the rest of his 30-minute observation period.  The client said he ?thinks? it was his ?anxiety? causing him to feel short of breath.  The client denied having any reaction to the Pfizer vaccine he received and requested to restart his COVID series with Pfizer. At 10:48 am, RN obtained approval via text message from Dr. to give the client a first dose Pfizer. The client received a first dose Pfizer COVID vaccine (lot # FK9895) on 06/29/2022 at 11:00am.  The client reported a history of feeling faint with blood draws and nauseous with vaccination. The client was given an apple sauce prior to vaccination and asked to lay down for the injection.  The client denied feeling nauseous or dizzy after vaccination, so RN and RN observed as he sat up.  The client said he felt ?ok,? while sitting so RN and RN observed while he stood up and the client said he felt, ?ok.?  At 11:09 am RN noted that the client was closing his eyes and swaying his body slightly while standing up.  His skin color was appropriate for race. He appeared sweaty but the outside temperature was 87 degrees Fahrenheit and the amount of sweat had not changed since vaccination.  The client stated, ?I feel dizzy.?  RN and RN instructed the client to lay back down.  He laid down and said, ?I feel nauseous.?  At 11:11 am, the client's vitals were taken.  Blood Pressure 144/82, respirations 18 and unlabored, SpO2 97%, heart rate 93 and the rhythm was regular per palpation.  The client denied pain, difficulty breathing, or feeling itchy.  He was given a juice to drink while sitting up.  At 11:14am the client's vitals were rechecked.  Blood pressure 150/88, respirations 18, heart rate 94, SpO2 96%.  At 11:15am, RN and RN asked the client to stand up.  The client stood up independently and said he felt ?fine.?  At 11:20am, RN rechecked the client's vitals while he was standing up.  BP 140/90, respirations 20, heart rate 102, SpO2 96%.  RN noted that the client's body appeared to be swaying back and forth and asked the client if he was starting to feel dizzy again.  The client said, ?No I don't feel dizzy.  I just feel a little anxious.?  RN educated the client about normal vaccine side effects and told him to seek care if his dizziness returned.  RN also referred the client elsewhere for follow up for an infected abscess and to receive primary care services.  The client walked away independently with a steady gait.
Subsequent to receiving one dose of varicella virus vaccine live the pt developed varicella  consisting of an unspecified number of lesions on his abdomen, chest, stomach, back, arms and legs.
Information has been received from a nurse concerning her 28 month old son who on 19-NOV-2007 was vaccinated (route and site not reported) with PEDVAXHIB (OMPC) (lot # not reported).  The patient was concomitantly vaccinated with DTaP (unspecified) (manufacturer unknown) and VAQTA (unspecified-manufacturer unknown) on the same day.  On 17-DEC-2007, post vaccination, the patient developed generalized hives, fever and a cough.  The nurse treated her son with diphenhydramine hydrochloride (BENADRYL).  At the time of this report the patient's outcome was not reported.  No additional information is expected.
Acute myocarditis vs stress induced cardiomyopathy 3 days after 3rd dose (booster dose) of Pfizer vaccine.
A few days after third shot, the lymph nodes in right armpit (shot arm) were swollen for about 3-4 days.; Dose received 3; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 22Nov2021 at 10:30 (Lot number: F63527) at the age of 44 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: Sulfa drugs. Concomitant medications included: CELEXA; CLARITIN and IBUPROFEN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EN6199, Route of administration: unspecified, Administration time: 16:30, Anatomical site: Left arm), administration date: 06Mar2021, when the patient was 44 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EN2613, Route of administration: unspecified, Administration time: 17:00, Anatomical site: Left arm), administration date: 29Mar2021, when the patient was 44 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021 at 10:30, outcome "unknown", described as "Dose received 3"; LYMPHADENOPATHY (non-serious) with onset 24Nov2021 at 06:00, outcome "recovered" (an unknown date in Nov2021), described as "A few days after third shot, the lymph nodes in right armpit (shot arm) were swollen for about 3-4 days". Therapeutic measures were taken as a result of lymphadenopathy.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the  COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment included ibuprofen for lymphadenopathy.
Got stiff and started flexing hands. Progressed into jerking of legs. Takes Keppra.
Patient reports left ear fullness with an inability to hear the day following the administration of Zostavax, with NO associated pain, fever, or discharge from the ear.  Also experiencing vertigo described as the feeling one gets after getting off a roller coaster and muffled hearing. Seen on 4/22/13 for on-going symptoms for Eustachian Tube Dysfunction r/o allergic rhinitis.  Rx'd fluticasone nasal suspension and took pseudoephedrine with no relief. Symptoms worsened as reported by patient 4/24/2013 in left ear.  Rx'd prednisone 1000 mg taper over 16 days and Valtrex 1000 mg twice daily on 4/29/2013 and began to improve.  Audiology exam on 4/29/2013 showed mild hearing loss in left ear.  MRI was negative for acoustic neuroma.  Pt reported tinnitus in left ear on 5/17/2013.  Symptoms continue to improve.
No additional AE; Improperly stored VARIVAX administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy, and concomitant medication was not provided.  On 09-AUG-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # S032356 was confirmed to be valid, expiration date 14-OCT-2021; dose, route of administration and anatomical location were not reported) for prophylaxis. The storage temperature was 9.6 Celsius degrees for 80 minutes. There was no previous temperature excursion. No additional adverse event details provided (no adverse event).  This is one of several reports received from the same reporter. Sender's Comments US-009507513-2108USA006030, US-009507513-2108USA005918, US-009507513-2108USA006125, US-009507513-2108USA006006, and  US-009507513-2108USA006146.
Swollen lt. arm, severe body aches and pain, headache, excessive sweating for 14 hrs.  Missed work on 1/27/2021. 8 hrs.
Headache fatigue, joint pain, body aches, swollen lymph node axilla of left arm
allergic reactions; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient had lot of allergies, about 15 different things already. The patient thought of having allergic reactions as his heart doctor have kept patient on different cholesterol (Unspecified medication). Reporter told them that my father was dead, but I did have to take some Benadryl (Taken as treatment) after the first shot. It's better tonight but somewhat, my question is someone had told me that if you're allergic to the shot it won't do any good you have to take it over again. Is that true. I have a lot of allergies to lot of things. At the time of this report event outcome was unknown.   Follow-up attempts are completed. No further information is expected.
Information has been received from an office staff concerning her 14 year old daughter who was vaccinated with the first 0.5 mL dose of Gardasil and two days later had her first menstrual cycle. The patient had no menses in between shots and had her second menstrual cycle after receiving the second dose of Gardasil. The patient also experienced injection site pain. The patient sought unspecified medical attention. The patient's status was not reported. There was no product quality complaint involved. No further information is available.