chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had an allergic reaction; face was swollen; face was red; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (had an allergic reaction), SWELLING FACE (face was swollen) and ERYTHEMA (face was red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ATORVASTATIN, LOSARTAN, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), MULTIVITAMINS & MINERALS PLUS LUTEIN and ZOLPIDEM for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jan-2021, the patient experienced SWELLING FACE (face was swollen) and ERYTHEMA (face was red). On 02-Feb-2021, the patient experienced HYPERSENSITIVITY (had an allergic reaction). On 02-Jan-2021, SWELLING FACE (face was swollen) and ERYTHEMA (face was red) had resolved. On 02-Feb-2021, HYPERSENSITIVITY (had an allergic reaction) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details was not reported by the reporter.
I had tinnitus. It was extreme ringing. I had an appt with an audiologist and an ENT and had a hearing test and hearing aids to help with the noise. The hearing aids has helped some to mask the noise. The ringing constant. The tinnitus still continues to this day.
PATIENT GOT LIGHT HEADED AND HAD ITCHINESS TO SITE OF HPV VACCINE. VOMITTED X 1.
Second dose administered 14 days after the first dose. The patient did not wait 21 days between the two-dose series to schedule the appointment. This was not caught by our pharmacy team through review of the pharmacy system.
4/12/16 Received PNEUMOVAX 5:00 PM; at 7 PM had severe pain left shoulder and arm (rate as 10); fever 99.6; 4/13/16 left arm edema/red shoulder -> elbow; made MD visit - given ZYRTEC and ZANTAC. 4/14/16 - MD visit edema, redness, warmth (L) shoulder -> elbow; LEVAQUIN x 5 days.
soar throat; stuffy/runny nose; sick; This spontaneous case was reported by a  and describes the occurrence of OROPHARYNGEAL PAIN (soar throat), RHINORRHOEA (stuffy/runny nose) and ILLNESS (sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (soar throat), RHINORRHOEA (stuffy/runny nose) and ILLNESS (sick). At the time of the report, OROPHARYNGEAL PAIN (soar throat), RHINORRHOEA (stuffy/runny nose) and ILLNESS (sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not provided. The Treatment information was not provided.
Female patient reports to the vaccination center on January 18, 2022, with a diagnosis of diabetes. She reported to the center without having breakfast, she was pale, weak and dizzy.
PMR got a lot wose and spread to my knees.  Had to increase my prednisone dose from 5mg to 7.5 and I should have increased it even more, because pain at 7.5 was barely tolerable
28JUL92 pt woke up w/blotchy rash on face, groin, & back; no temp; will give APAP if fever appears; 11AUG92 rash lasted 4 days-no temp; full recovery reported by mom;
9/15 1500 noticed pain, redness and injection site by 9/19 area was swollen to approximately 3 inch in diameter area quite painful.  Swollen, redness decreased by 9/17/06.
tested Covid positive/Caller states she is vaccinated and boosted and can't believe she got Covid; tested Covid positive/Caller states she is vaccinated and boosted and can't believe she got Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 16Apr2021 as dose 1, single (Lot number: ER8733), in left arm, on 07May2021 as dose 2, single (Lot number: EW0158), in left arm and on 06Dec2021 as dose 3 (booster), single (Lot number: 33030BD) at the age of 59 years, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Apr2022, outcome "unknown" and all described as "tested Covid positive/Caller states she is vaccinated and boosted and can't believe she got Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Apr2022) positive, notes: Unit: Not Provided.  Clinical Course: Vaccination Facility Type: Pharmacy/Drug Store. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations: None, doesn't even get the flu shot. States as a matter of fact she had the least symptoms with Pfizer vaccine and wondered if it was effective, she barely had a sore arm.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
got COVID; got COVID; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the parent.  A 7-year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2 (tris), single and (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got COVID".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A contributory role of BNT162B2 to event got COVID cannot be excluded based on temporal association and available information.,Linked Report(s) : US-PFIZER INC-202101723682 Same patient, different vaccine dose number and different event.
Pt had local swelling and redness with increased warmth about 4cm X 5cm.
Faint papular rash on cheeks - low grade fever to 100, significant personality change - cried + 2 hours for no reason, increased anxiety, inane questions: "What do trees have to do with life?"
Allergic reaction: The patient has had a skin rash but not had trouble swallowing. He has had swelling (periorbital). No difficulty breathing or dizziness. This started just prior to arrival and is still present. A cause has been identified (tdap injection). He had recently taken medication (tdap). No treatment prior to arrival.
MMR II that had undergone temperature excursion was administered; No additional AE reported; This spontaneous report was received from a physician's office manager and refers to a male patient, who would be 5 years old at the reporting time. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) subcutaneous injection, lot # T034388 was confirmed to be valid, expiration date 08-OCT-2022, administered for prophylaxis (dose, route of administration, and anatomical location were not reported). Administered dose of the vaccine was stored in temperature of 54.7 degrees Fahrenheit for 58 minutes.  There were no previous temperature excursions reported. There was no additional adverse event reported (No adverse event).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA002449:
Redness and swelling below the site of injection, starting below the left deltoid muscle and extending to above the elbow.   The patient reported the reaction has gotten progressively worse since the administration.  Patient afebrile and reports no other reactions.
This spontaneous report was received from a registered nurse (patient's mother) reporting on a 18 year old male patient. The patient did not have any pertinent medical history, drug reactions or allergies. On 29-SEP-2015, the patient was vaccinated with VARIVAX (Merck) (1.0 ml, lot # and expiration date were not reported), subcutaneously, for a school requirements. The patient did not have any concomitant medications. On 04-OCT-2015, the patient developed a headache, a high fever, fatigue and was "so sick". The patient took TYLENOL and ibuprofen as a treatment, however TYLENOL "did not help". The patient woke up on 06-OCT-2015 and was covered with a rash everywhere, it was on his skin, his mouth, his throat and even his eyes and was itchy. The patient sought medical attention, was seen by an unspecified physician and was diagnosed with chickenpox. The patient was taking BENADRYL for the itching. The reporter thought it was an overdose since the correct dose of VARIVAX (Merck) was 0.5 ml. The outcome of the events was reported as not recovered. The relatedness between the events and VARIVAX (Merck) was not reported. Additional information has been requested.
Received vaccine on 2/9. Only sore arm until  2/12. Woke up that morning with extremely sore arm, red, blotchy patch of skin around injection site about the size of the palm of my hand. It was hot to the touch. At the injection site itself, there was an area about the size of a quarter that was slightly swollen. The entire area was extremely itchy! Today is 2/16 and the red area is just disappearing. It still itches. My arm is still sore. I have also been running a low grade fever since the injection.
Flu-like body aches and shivers; increased pain with migraine; significant lethargy
Felt dizzy after the vaccine but is now (at 5:25pm) feeling better.
septic shock; Initial information received on 10-Dec-2021 regarding an unsolicited valid serious case from consumer's son via pharmacy.  This case involves a 75 years old male patient (weight: 67.131 kg/ 148 lb) who had septic shock, after receiving INFLUENZA VACCINE and TREPROSTINIL SODIUM [TYVASO].  The patient's past medical history included Physical therapy and Occupational therapy.  It was unknown if the patient had any risk factor.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing medical history of Pulmonary arterial hypertension.  Concomitant medications included NINTEDANIB ESILATE (OFEV) [other dosing details were not reported.]  On 07-Jul-2021, the patient began therapy with TYVASO (TREPROSTINIL SODIUM), (concentration of 0.6 mg/ml) [lot and expiration date were not reported] delivered by Tyvaso Inhalation Device (TD-300/A) for secondary pulmonary arterial hypertension. The current dose was reported as 18-72 gram (3-12 breaths), four times a day (QID) via inhalation (IH) route.   On an unknown date in November 2021, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (Total, lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On 19-Nov-2021, the patient developed a serious septic shock, (unknown latency) following the administration of INFLUENZA VACCINE and 4 months 13 days following the administration of TYVASO.   This event was assessed as medically significant and he was hospitalized for this event.  It was unknown if the patient experienced any additional symptoms/events.   There were no lab data/results available.   Action taken with the TREPROSTINIL SODIUM (TYVASO) was not reported for the event of septic shock.    He was started PIPERACILLIN SODIUM, TAZOBACTAM SODIUM (ZOSYN) antibiotic on 19-Nov-2021 and should finish it by 06-Dec-2021.   At the time of reporting, the outcome of septic shock was unknown.  The reporter did not provide causality for the event of septic shock.   Senders Comment: The company has assessed the serious adverse event of septic shock as not related to IH treprostinil and TD300/A device. The event was likely due to infectious process.   Information on the batch number was requested.; Sender's Comments: This case involves a 75 years old male patient who had septic shock, after receiving INFLUENZA VACCINE and TREPROSTINIL SODIUM [TYVASO]. The time to onset is difficult to determine. The event was likely due to infectious process. The patient's past medical history included Physical therapy and Occupational therapy. At the time of the event, the patient has ongoing medical history of Pulmonary arterial hypertension. Concomitant medications included NINTEDANIB ESILATE (OFEV). Further information regarding their previous vaccination tolerance and laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of suspects cannot be assessed.
Pruritus began in both legs (ankles to knees)and  spread to beltline. Applied Cetaphil skin lotion. Resolved 4 hours later. No visible cutaneous changes other than excoriations from scratching. Patient reports similar pruritus frequently after bathing.
Patient stated he needed something to eat about 15 minutes after the vaccine. Then said he felt dizzy and like he was going to faint. We got him to a chair. He said he hadn't eaten all day (6 pm).
The patient fainted about 15 minutes post-vaccination. Elevate Hr 115 BP 95/65  RR: 20 unlabored. Took 5-7 minute for symptoms to subside.  Vital signs were taken again HR 90 BP 98/64 RR 18 and the stable patient stated that she felt fine and was going home. He spouse was driving her home.
Right arm edema, pain, erythema, and excoriation at site of second vaccine. During the first vaccine of Moderna I experienced edema, erythema and pain five days post left arm vaccination. the second dose the reaction occurred within hours of vaccination.
Seriousness criteria: other-medically significant.  Initial report was received from a health care provider on 03 January 2008.  A 31-year-old male patient had received Imovax Rabies vaccine, lot number K1120 and Rabies Immune Globulin (manufacturer not reported) during an emergency room visit for a possible rabies exposure following a cat bite in 1996.  The dates of product administration, and routes/sites of vaccination were not reported.  Following treatment, the patient was diagnosed with asthma; the dates of diagnosis and onset of symptoms and the patient's medical history were not provided.  It was not reported if the cat had been confirmed rabid or if testing results were available.  No further information had been provided at the time of the report.
Muscle cramping in calves up to one month after 2nd shot; Muscle fatigue in arms and legs to this date (6 weeks after 2nd shot)
SHORTNESS OF BREATH; FEVER; 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: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 103 F. On 13-APR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F. On 14-APR-2021, the subject experienced shortness of breath. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, and shortness of breath. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Patient received expired vaccine. DH and Pfizer recommend revaccination. Patient was contacted to schedule an appointment. Patient will call back to schedule.
Sharp pain in genitals like razor blades in underwear. Still experiencing symptoms 18 months later. Started day after second shot
Fever 103' lasting 5 days, significant papular rash covering entire body, mild nasal congestion. swollen eyes, conjunctivitis or brassy cough.
Uncontrollable shaking and chills, body aches in all joints, diarrhea and sleepy. Lasting couple days.
Feb/March 2022 - began having some shortness of breath and occasional chest pain that was not normal for me, also felt more tired than usual 5/22/22 - Woke up around 1230 am having some discomfort in my right lower chest and it worsened over the next few hours while i was in bed. Became very uncomfortable lying down, especially lying supine and flat. I went to the ER and by the time I arrived it was very difficult and very painful to inhale and I was not able to lie flat at all due to pain and shortness of breath in that position. Labs, EKG, and CXR were obtained. D-Dimer came back elevated at 0.66. CTA was obtained. The original radiologist report was pleural effusion.  5/31/22 - Followed up with my PCP. see below Performed peak flow meter at visit with result of 250. PFT and repeat CTA ordered. 6/2/22 - Second radiologist reviewed CTA from 5/22/22. He called and spoke with ER provider and i was sent to ER for dx pulmonary infarct and pulmonary embolism. Labs and EKG were obtained. After discussion with ER provider i was determined to be stable enough for outpatient treatment. i was started on Eliquis 10 mg PO BID for 1 week, then started Eliquis 5 mg PO BID for minimum 6 months. i have continued to have some shortness of breath and occasional chest pain. Both seem to occur more with exertion.
Initial report received from a health care professional on 10 May 2010: This patient was vaccinated with MENVEO (batch no: unknown), (dose: unknown), intramuscularly on 07 May 2010. On 07 May 2010, approximately 2 hours after injection, the patient experienced dizziness and nausea, the symptoms lasted for 24 hours. The outcome of the events was reported as recovered. Combined follow up report received from a consumer on 07 May 2010: The report was initially reported to Novartis on 07 May 2010 and not on 10 May 2010. It was reported that the patient was vaccinated with 0.5ml of MENVEO. It was reported that the after one and half hour of vaccination the patient experienced lightheadedness. The outcome of lightheadedness was reported as ongoing.
Rash from top of shoulder to mid arm ITCHY Raised area where rash is Area has a fever
Fever developed late afternoon on 8/1 around 4 pm ET. Fever continued through morning of 8/3, fever broke around 10 am ET on 8/3. Fever temperature presented around 101.8 and increased to 103 (rectal temperature). Temperature ranged between those two points from 8/1 to 8/3 unless medication / pain reliever was given. Child was giving children's Motrin at a dose per the age/weight instructions (5 ml). Dose d given once on 8/1, twice on 8/2 and once on 8/3. About 6 hours after fever broke, a rash was noticed on the child's butt cheeks.  Rash appeared as muted red spots approx. 5 millimeters in diameter. Rash spread to back, chest, stomach, neck and cheeks/face the following day (today - day of reporting of incident). Called the clinical line of my doctor's office (doctor noted in this form). Doctor's office advised rash was likely either related to the MMR shot or possibly Roseola (may also be related to MMR shot). Dr. cannot see patient today, and advises to monitor through the weekend and come in on Monday (8/7) if symptoms persist.
Information has been received from a physician concerning a 30 year old female patient no known pertinent medical history and no known drug reactions/allergies, who was vaccinated with the first dose of GARDASIL route and lot# not reported, on 01-NOV-2006, the second dose on 03-JAN-2007, and the third dose on 09-MAY-2007. Concomitant drug included unspecified birth control medicine. In 2009 the patient experienced seizures starting on an unspecified date. The patient's outcome was unknown. No diagnostic laboratory tests were performed. Upon internal review, seizures was determined to be an other important medical event. Follow-up information has been received on 31-AUG-2010 from a physician who reported that the patient did not have past history of seizures and the patient also did not have a family history of seizures. The patient received three doses of GARDASIL at another unspecified physician's office on the following dates, first dose on 01-NOV-2006, Lot number 653938/0954F, second dose on 03-JAN-2007, Lot number 655165/1425F and third dose on 09-MAY-2007, Lot number 657622/0388U. The patient had some health issues after she had received the series. The patient was seeing a neurologist. At this time of reporting the cause for seizures was unknown. Additional information has been requested.
PT states since receiving vaccine on 4/13/21 she has been sore and in pain in vaccination arm
11am -Patient was in the Observation post vaccination 1st dose of Pfizer. She c/o palpitation and mild chest pain.  Vital signs were taken as follows : BP 106/69, HR 98, Resp 20, Temp 97.9, Oxygen level 90%. . 911 was called. Emergency Team came and evaluate the patient. EKG was done  shows Sinus Rhythm.  Patient went with the EMS for further evaulation
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX injection (lot # L006384, expiry date: 25-FEB-2017; lot # L017143, expiry date: 13-MAY-2017; lot # L012034, expiry date: 07-APR-2017; strength, dose, site and route of administration were unspecified). No concomitant medications were reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
c/o inc weakness, sl dyspnea, & inability to walk. Recvd flu vax 4 day /a. Difficult to get around, fell 4 times, admitted had high respiratory rate, sl dependant edema, defect of sensation below knees, dx GBS, pemphigoid, HTN
Over a four hour period developed exacerbation of angioedema of the neck and moderate worsening of asthma that lasted for approximately two weeks. Also developed diarrhea, which lasted approximately two days.
she received her first Shingrix vaccine in October 2022; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose 0.5 ml, Intramuscularly in an unknown arm).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: she received her first Shingrix vaccine in October 2022). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 26-MAY-2023 The reporter stated now she would go to receive her second dose of Shingrix vaccine. The reporter did not consent to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Due to allergenic history the patient was to be observed for 30 minutes. After 20 of the 30 minute observation the patient complained of tongue swelling, and some feeling of distress. Clinic RN and physician assessed patient and she was taken to the ED for evaluation and treatment.