chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FEELS WORSE; SICK; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and per procedure no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced feels worse, and sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feels worse and sick was not reported. This report was non-serious.
She got the vaccine, went home and went to bed.  She woke up around 5:00 AM and was a little light headed, but as the day went on she found herself holding onto the wall and then had to get her cane.  She does have Meniere's disease.  She had a sick stomach, not nausea.  Some days were a little better than others.  She got up slower, and that didn't help that situation.  She called her doctor and told them how she was feeling, and she was asked if she wanted to come into the office, and she declined.  Then a few days went by and she did not feel any better.  She reached out to her family and they told her to call somebody and that's when she read her paperwork and called us.
pt phone stating next day p/inj pt devel red spots on legs;then on 24JUL96 noticed lips swollen & ankles swollen;advised to observe, call back & be seen if sx inc;
Mild fatigue and headache day after first shot only, and mildly sore arm for a week or so. After second shot -3 days very sleepy, increased chest pain, increasing activity intolerance, then less sleepy but severe activity intolerance, palpitations and tachycardia sitting up for extended periods, SOB with walking distances or stairs and sharp chest pains again, waking from sleep SOB, unable to tolerate lying flat on back with SOB. It was like much earlier in the long Covid again. About 1 month after the vaccine I took prednisone 20mg for 5 days, against medical advice and all symptoms improved, to just a little worse than before the vaccine.  My mother had a similar reaction to the first dose and was hospitalized, and got no testing or treatment, just monitoring. She had Covid at the same time as me.
The person received 0.3ml of the undiluted Pfizer covid 19 vaccine. The person reported no adverse effects at 20 min and 4 hours after receiving vaccine
Left arm tingling with discomfort about 45 minutes after flu vaccine followed by a closing of the throat sensation. Seen in urgent care and given 25mg BENADRYL with 40mg prednisone orally. EKG and O2 monitored. Patient was feeling better but still complained of some throat tightness and was referred to ER. She refused travel by ambulance and was driven by her father. Seen in ER at 5:04pm and now complaining of itching and presenting with erythematous rash to the chest. IV fluids with BENADRYL given with another 20mg prednisone. Afterwards throat feels better and itchiness and rash resolved. Discharged with RX of prednisone 20mg, take 2 tabs by mouth for 3 days.
swollen, red lymph node; 2 months after 2nd vaccine swollen, red lymph node came back in same armpit has been inflamed one week to date; swollen, red lymph node; This is a spontaneous report from a contactable consumer (Patient). A 52-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 05Feb2021 as dose 2, single for covid-19 immunisation from hospital. Medical history high blood pressure, hypothyroidism, depression, allergies to several antibiotics. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and Patient received prescription medications within 2 weeks of vaccination. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 15Jan2021 as dose 1, single for covid-19 immunisation and had Large swollen lymph node in armpit of shot went away after 2 weeks. In 2 months after 2nd vaccine patient experienced swollen, red lymph node came back in same armpit has been inflamed one week to date. The patient did not receive any treatment in response to the events. The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
This spontaneous report was received from a physician via a company representative referring to a patient of unknown age and gender. The patient's medical history, drugs reactions or allergies, concurrent conditions and concomitant therapies were not reported. On 22-DEC-2014, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB. Lot number K008986 with expiration date of 01-APR-2016 (route and anatomical location of administration were not reported). The vaccine had two temperature excursions one of 48 hours with a lowest recorded temperature of 32 Fahrenheit (F) (0 Celsius(C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
Patient developed pinpoint raised rash on trunk, face, legs and arms. Afebrile, no N/V/D as per caregiver. Rash resolved by 6/7/12 - No medical Tx sought.
Period cramping; This spontaneous case was reported by a consumer and describes the occurrence of DYSMENORRHOEA (Period cramping) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Period pains (gets cramping on period). Concomitant products included IBUPROFEN for Menstrual cramps.    On 27-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSMENORRHOEA (Period cramping). The patient was treated with PARACETAMOL (TYLENOL) for Menstrual cramps, at a dose of UNK dosage form. At the time of the report, DYSMENORRHOEA (Period cramping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that cramping was not from vaccine.   Reporter did not allow further contact
Fever of 102 degrees F. after vaccine and it lasted for 2 days. The flu-like symptoms along with sore throat resolved without treatment.
25OCT nausea, vomiting; 26OCT fever, sweating; 27OCT lt hand not functioning; 5NOV shooting leg pain; 6NOV weakness of lt leg, numbness;
cough; runny nose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Mar-2021 and was forwarded to Moderna on 01-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough) and RHINORRHOEA (runny nose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced COUGH (cough) and RHINORRHOEA (runny nose). At the time of the report, COUGH (cough) and RHINORRHOEA (runny nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Body aches, low grade fever, chills 4 days after vaccine; Body aches, low grade fever, chills 4 days after vaccine; Body aches, low grade fever, chills 4 days after vaccine; This is a spontaneous report from a contactable other HCP (patient).  A 32-year-old female patient received the first dose of BNT162B2 (lot number: EJ1685), via an unspecified route of administration on 28Dec2020 09:45 at single dose in the right arm for COVID-19 immunization. Medical history included hypothyroidism from an unknown date. Concomitant medication included levothyroxine and topiramate. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced body aches, low grade fever, chills 4 days after vaccine on 01Jan2021 15:30. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included nasal swab: negative on 02Jan2021. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Patient presents with red raised swollen bumps at injection sight and appears with labored breathing requiring oxygen , patient vitals were taken , with elevated blood pressure and palpitations. 911 was called and patient sent to nearest hospital for treatment and observation
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 30-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On unspecified date, the subject received 1st dose and 2nd dose of ENGERIX B (details unknown). On 8 July 2013 the subject received 3rd dose of ENGERIX B (20 mcg, unknown route, left arm). The subject experienced not responding to therapy. At an unspecified time after completing the ENGERIX B series, the subject was found to have no response to the vaccination.
PT WAS VACCINATED USING PFIZER 2/15/21 (LOT EL9267) + 3/11/21 (LOT EN6206). S/O BEGAN 8/30/21, TESTED + 9/3/21
Patient is a 89 y.o. male patient of local MD with history of Dementia, presented from ER for weakness, covid related anorexia, hypoxia, new onset afib.    Acute hypoxic respiratory failure, resolved Possible pneumonia vs. Pulmonary edema Sepsis, POA, now resolved Covid 12/20/22 AF, WBC 15.6-- >12.3, LA normal, EKG now with sinus tachycardia Was 87% on RA needing brief supplemental oxygenation support through nasal cannula, currently on room air, not on home O2 chronically.  Covid + this time, CXR with edema, D dimer >5, BNP 1704 (likely due to RVR) Received IVF, dexamethasone, cefepime, levaquin at HCF Consulted HCP; continued dexamethasone and Added mucinex, albuterol, covid cocktail Procalcitonin 0.68  On Azithromycin and Ceftriaxone.  Discontinue azithromycin as Legionella antigen negative. Sputum culture pending. Echo showed grade 2 diastolic dysfunction, normal LVEF. Discharging on oral cefdinir for 5 days per HCP.  No need for steroid at discharge as hypoxia was corrected   New Onset Afib with RVR Pt does not have hx of Afib but does have history of weakness and falls TSH, K normal; checking Mg and CTPA to rule out PE from covid  Needed IV cardizem gtt but self converted to NSR Given PO cardizem in ER and will continue  S/b cardiology recommended anticoagulation  D/w spouse regarding risk vs benefits  would like him to start anticoagulation  Start Eliquis, ASA discontinued  Continue cardizem 120 mg daily    Acute on chronic renal failure stage 3 Cr baseline likely 1.2; was 1.9 on 12/20 but improved to 1.3 this morning    Dementia Continued home aricept and namenda Likely at his baseline.
Volunteer received Moderna dose on 12/30 and then came in to receive 2nd dose on 1/6.  Received Pfizer dose on the 6th. She states feels fine, no adverse side effects. Instructed NOT to come on 1/27, when her next appointment was scheduled.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Sep2021 as dose 1, single (Lot number: EN6201), on 10Mar2021 as dose 2, single (Lot number: EN6198), in left arm and on 27Sep2021 as dose 3 (booster), single (Lot number: 30135BA) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "type 1 diabetes" (unspecified if ongoing). Concomitant medication(s) included: MOTEGRITY, start date: 07Mar2022; LEVOTHYROXINE, start date: 06Feb1922; INSULIN; ACINON ELI LILLY, start date: Mar1990; MUCINEX, start date: 31Mar2022; ADVIL CONGESTION RELIEF, start date: 31Mar2022; TYLENOL, start date: 31Mar2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.clinical course: Patient reported that at starting Paxlovid had intense muscle pain in neck and left shoulder blade. Patient took Tylenol and ibuprofen & ice packs 24/7 to manage the pain. Patient also reported that when 5 day dose of Paxlovid ended , on day 6 & 7 the pain had started to decrease .
Tinnitus.  Tinnitus within 24 hours of first dose. Went away. Tinnitus again within 24 hours of second dose, this time persistent. Continue 5o have tinnitus 5 months later.  Saw primary care who examined ans referred to ENT. ENT tried does of steroids which did not help. Diagnosis osed with tinnitus.
Oval shaped 3-4 inch diameter redness and swelling and 2 large blister below injection site that ruptured day 4 post injection  multiple smaller blisters.
Felt fine until the next day I started having a bit of trouble breathing, headache, feverish, sweaty, etc.
pt recv vax 23OCT98 & after less than 1min of vax pt exp dizziness & fainted;BP & vital signs were monitored;
Injection is a little tender after receiving the dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection is a little tender after receiving the dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced VACCINATION SITE PAIN (Injection is a little tender after receiving the dose). At the time of the report, VACCINATION SITE PAIN (Injection is a little tender after receiving the dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
A BIT STIFF AT INJECTION SPOT ON RIGHT ARM; 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 not reported, batch number: Unknown) dose administered on right arm, start therapy date were not reported 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 an unspecified date, the subject experienced a bit stiff at injection spot on right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a bit stiff at injection spot on right arm was not reported. This report was non-serious.
PATIENT STATED PRIOR TO RECIEVING VACCINE THAT SHE HAD BROKE OUT IN A RASH WITH THE FIRST DOSE.  ALSO HAD BEEN ON MENTRAL CYCLE SINCE LAST FIRST DOSE.  NOTIFIED MD.  STATED TO HAVE HER WAIT 30 MINUTES TO GIVE VACCINE.  ALSO WANTED PATIENT TO FOLLOW UP WITH GYNOCOLOGIST, THAT THE MENSTRAL CYCLE WAS NOT A SIDE EFFECT OF VACCINE.  GAVE VACCINE.  PATIENT BROKE OUT IN HIVES AND WAS ITCHING.  NOTIFIED MD AGAIN.  SATED  TO TAKE BENEGRYL AFTER LEAVING WORK, WHICH HER SHIFT WAS ABOUT TO END.  AND IF SWELLING DEVELOPED AROUND NECK MOUTH AREA TO GO TO THE ER. VS: HR89, RR 20, BP 128/78.
Severe explosive diarrhea; This is a spontaneous report from a contactable female other health professional reported for herself. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on an unspecified date at 15:45 (Lot number: EL9269) via an unspecified route of administration in the left arm at single dose for COVID-19 Immunization in the Public Health Clinic. The patients medical history included She had sulfa and latex allergy. The patients concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested after vaccination. On 14Feb2021 04:30 the patient had severe explosive diarrhoea within 12 hours of injection. Diarrhoea, several times per day, accompanied by loud rumbling, bowel sounds. Bowel movements would be watery and worsen with the ingestion of any form of solid foods. No bloating or cramps. The event assessed as serious (medically significant). The patient didn't receive treatment. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the strong temporal relation, the association between the event diarrhea and the administration of the vaccine cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
I had a little tenderness and soreness in my arm for a couple of days. It was difficult to raise my arm. I tested positive for COVID-19 on 05/09/2022. My symptoms started on 05/07/2022 respiratory problems, bad cough, difficult to talk and very tired.  I called our doctors office and was put in  touch with a COVID-19 specialist. They prescribed Paxlovid.
-urticarial rash from head to toe approx 24 hrs after getting immunization -responded to Benadryl
Flares and inflammation of Hidradenitis Suppurativa. Heavy and clotty periods. Abnormal labs (CBC)
Uncontrollable crying, fussy. Seen at office 4 days after vaccine administration. Seen at ER 8-9 days after vaccine administration with persistent, unconsolable crying.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021 at 1:51 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Feb-2021 at 1:51 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 71.94.  Concomitant products were not provided.  On 08-Feb-2021, Excursion time was 10 AM and 11 AM, temperature was 29 and 35 respectively, total doses given for the day was 30, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 02-Feb-2021, vial was moved to clinic on 08-Feb-2021. 3 vials was sent to clinic. Vaccine BUD dates was 04-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
This spontaneous prospective pregnancy report was received from the office manager, referring to a female patient of unknown age. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On 05-NOV-2018, the patient was vaccinated with a dose of GARDASIL 9 (dose, frequency, lot # and expiration date were not reported) intramuscularly, for prophylaxis. It was stated that patient inadvertently received GARDASIL 9, instead of PNEUMOVAX23. No treatment was provided for this event. The reporter stated the patient was currently pregnant at this time, and the last menstrual period (LMP) and estimated date of delivery (EDD) were not known. No adverse events. No further information provided.
since 3/17/99 pt recv vax & teacher has noticed behavior changes & an inc in the frequency & degree of complaints & joint & muscle pain;pt teacher also reports has noticed occasionally falling w/o noted cause;
My usual allergic reactions occur anywhere from 48-72 hours after an event. Massive tongue swelling
Site: Pain at Injection Site-Medium, Additional Details: Patient complains of sore arm since her vaccine. She plans to visit her PCP.
welts, sometimes red, varying in size form mosquito bite to almost a half dollar size; intense itching, worse today than a/;
Information has been received from a healthcare professional concerning a 45-month-old female twin with no other pertinent medical history or allergies who on 03/20/2003, was vaccinated subcutaneously in the right leg with a 0.5 ml dos of varicella virus vaccine live (Oka/Merck) (lot #64115/0793M). There was no concomitant medication. On 11/27/2005, the patient broke out in red papules, she presented to the physician's office on 11/28/2005 , with red papules on her face, forehead, trunk, upper and lower extremities and did not have a fever. The patient was treated with acetaminophen (Tylenol), calamine lotion, diphenhydramine hydrochloride (Benadryl) and fluids. There was no information provided regarding the present status of the patient. No product quality complaint was involved. The patient's twin sister was also vaccinated with a dose of varicella virus vaccine live (Oka/Merck) and developed an adverse reaction (WASE# 0512USA00001). Additional information has been requested.
Stinging & itching at injection site for 1 week, pt. is getting better.