chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Site was sore the day the vaccine was given.  Next morning it was hard to reach overhead with that arm I had less energy than usual and a slight headache similar to seasonal allergies.  I was able to go through my day as usual until about 7:00 pm when I just stared feeling very tired.  At 8:15 i felt feverish and took temperature 100.4.  I did take 2-  500mg Tylenol.  At about 9 fever was 101.7.  I rested and dozed.  At 10:30 temperature was 99.0.  This morning I feel fine and my arm is still sore at the site but I can  lift it no problem. I took my temperature at 8:30 -98.6 and it is now 98.9.
Swelling of throat and tongue, racing heart and shaky right arm 1 to 2 minutes after receiving the shot. Doctor and Nurse on site monitored me. Doctor checked my heart with stethoscope. RN checked my blood pressure. I had taken zyrtec the night before the shot. The symptoms stopped progressing after about 10 minutes. I felt fine 30 minutes after the shot and went home.
Fluzone HD was given to a patient under the age of 65 with no reported adverse event; Initial information was received  on 22-Nov-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves 64 years old patient of unknown gender who was administered Influenza USP trival A-B high dose subvirion vaccine [Fluzone HD] under the age of 65 years with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect Influenza USP trival A-B high dose subvirion vaccine; form: Suspension for injection in pre-filled syringe (strength, dose, frequency, lot number and expiry date: not reported) via intramuscular route in unknown administration site as prophylactic vaccination (Immunisation).  On an unknown date, the patient received a dose of Influenza USP trival A-B high dose subvirion vaccine under the age of 65 years with no reported adverse event (off label use) (unknown latency).  No lab data was reported.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (Fluzone HD was given to a patient under the age of 65 with no reported adverse event).  Outcome: Unknown
I started to have blisters on the palm of my hand. Most blisters are on my left hand. Few on my right hand and one on my right feet. I also have rashes on the back of my lower thighs.
SEVERE shortness of breath (basically hyperventilating) for 2-3 hours, very sharp pains/heartburn in the chest when trying to take a deep breath, nausea, vomiting, diarrhea, joint pain, fatigue, chills/hot flashes, sudden uncontrollable fatigue (deep sleep for 2-3 hours after)
Headache, body aches on 6/24/21, 0 adverse reaction on day 2 after vaccine .3 days after vaccine temp of 99.3 then resolved.
12JUN97 1245PM mom reported that pt had broken out in a rash, could it be from the shots given 3hr earlier;instructed mom to call MD who recommended warm bath & juice PO 16JUN97 AM;mom reported that rash was d/t allergy to peaches;
Narrative: 71 y/o M found to have low grade fever 99.6F on 1/6/21 at 9:30am s/p COVID-19 Vaccine Dose #1 received on 12/28/20 at 13:42. Acetaminophen 650mg q8h ordered for post vaccination symptoms and 650mg was administered 1/6/21 at 12:40 w/ resolution of fever.
Tested positive for COVID; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Tested positive for COVID) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for COVID). The patient was treated with BAMLANIVIMAB for Adverse reaction, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Tested positive for COVID.     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.   No concomitant medications were reported.  This is a spontaneous case concerning  a patient of unknown age and gender, with no relevant medical history, who experienced the unexpected non-serious event of covid -19. The event occurred approximately on an unknown day after the first dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as the event happened after the first dose. The events outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: This is a spontaneous case concerning  a patient of unknown age and gender, with no relevant medical history, who experienced the unexpected non-serious event of covid -19. The event occurred approximately on an unknown day after the first dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as the event happened after the first dose. The events outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
After 5 minutes from giving the vaccine. Patient started to say he was getting dizzy.  He lost coloration at first, but could speak just fine.  Then a few seconds later he appeared to lost consciousness, his head fell back, and he started to have jerking movements.   He was making noises that almost sounded like a snore to me right at first, but it was more than likely him gagging on saliva.  911 was called, and his symptoms continued for roughly 30-60 seconds.  EMS took him to hospital where they diagnosed it as vasovagal syncope and just gave him some fluids.
Blood clot in LAD which caused  a STEMI; Blood clot in LAD which caused  a STEMI; This is a spontaneous report received from a contactable consumer (female). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6208), first dose via an unspecified route of administration, administered in Arm Left on 20Mar2021 08:15 (at the age of 49 years old), single dose for covid-19 immunisation. Medical history included hypothyroidism, Penicillin allergy, both from an unknown date. The patient was taking unspecified concomitant medications within 2 weeks of vaccination. The patient experienced blood clot in lad which caused  a STEMI on an unspecified date (reported as 03Mar2021 15:15, for clarification since before vaccination date). The outcome of the events was unknown. The events was assessed as serious, causing hospitalization, disability and was life-threatening. Treatment for the events were Balloon in LAD / clot buster. The patient underwent lab tests and procedures which included COVID-19: negative on 03Mar2021. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Information on Lot/Batch number was available. Additional information has been requested.
Client waited 15 minutes then notified volunteer they wanted to speak with a nurse, reported to nurse "head feeling like it will explode" Client complains feeling weak and has hx of anxiety attacks. BP 180/106, P 96. Client denies throat swelling or difficulty breathing. Client complaint of feeling numb. EMS called. RN also called client's husband at client's request because se wants his support, advisedmeeting at ER. 2nd Bp 184/107. EMS took over medical care and transported client to ER.
This spontaneous report as received from a female medical assistant of unknown age via a company representative refers to herself. The patient was vaccinated subcutaneously with M-M-R II (lot number, expiry date, dose, site not reported) on an unknown date "10 years ago" approximately in May 2003. The patient experienced severe M-M-R II localized reaction at the injection site, on an unknown date "10 years ago" approximately in May 2003. No treatment was given, but the event subsided and the patient made a full recovery. Additional information is not expected.
Recurrent giant cellulitis-like Sweet syndrome induced by SARS-CoV-2 Pfizer-BioNTech mRNA vaccine; This is a literature report.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ACUTE FEBRILE NEUTROPHILIC DERMATOSIS (medically significant), outcome "unknown", described as "Recurrent giant cellulitis-like Sweet syndrome induced by SARS-CoV-2 Pfizer-BioNTech mRNA vaccine".; Sender's Comments: As there is limited information in the case provided, the causal association between the event acute febrile neutrophilic dermatosis and the suspect product BNT162B2 OMI XBB.1.5 cannot be excluded. The case will be reassessed once new information is available. 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.
Dose Number 1:28-MAR-2021/Dose Number 2:28-MAR-2021; Missed menstrual cycle; Dose Number 1:28-MAR-2021/Dose Number 2:28-MAR-2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 28Mar2021 (Lot number: ER2613) at the age of 29 years as dose 1, single and administration date 28Mar2021 (Lot number: EW0164) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset Apr2021, outcome "unknown", described as "Missed menstrual cycle"; OVERDOSE (non-serious) with onset 28Mar2021, outcome "unknown", INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown" and all described as "Dose Number 1:28-MAR-2021/Dose Number 2:28-MAR-2021". Therapeutic measures were not taken as a result of menstrual disorder, overdose, inappropriate schedule of product administration.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient did not diagnosed with COVID-19. Since the vaccination, the patient not tested for COVID-19. Device Date:10May2021  No follow-up attempts are possible. No further information is expected.
Developed sub acute thyroiditis.  Have been followed by Endocrinologist post partum.  Doctor suspects may have been experiencing post partum thyroiditis with minimal symptoms however suspect that following vaccine with strong immune response, triggered sub acute thyroiditis.
About 30 min after receiving my first shot I felt itchy on my arms. About an hour after the shot, I realized my arms and legs had multiple hives. It was extremely itchy. I took Claritin and Tylenol about 2 hours after the shot an the hives and itchiness was gone by 6 hours after the shot.
Itchy rash developed 24 hrs after vaccinated at site and down arm to wrist-lasted 2 wks.
Received 3 vaccines on Tuesday morning, that evening MOC noted tactile temperature.  On Thursday he developed a rash on his arm and torso that has now spread to his back.  MOC reports he has been eating, drinking and acting fine and that the rash does not bother him.  Patient not seen since Tuesday, all reporting has been by phone.
Received shot on Friday afternoon.  On Saturday morning had sore arm at injection site.  Then developed very achy shoulder, with ache spreading up neck and down back on left side.  Some fatigue as well.  Aches dissipated after a couple of hours, but fatigue continued and worsened on Sunday and continued into Monday.  Also on Monday, woke up nauseated, and it continued, on and off, throughout the day until bedtime.  Nausea gone on Tuesday, but still a bit more tired than usual.
Swelling but it was very sensitive to the touch; discomfort I felt on the left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: EWD177) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL taken for blood pressure abnormal; HYDROCHLOROTHIAZIDE taken for hypertension. Vaccination history included: Flu, for Immunization, reaction(s): "fatigue", "achy". The following information was reported: VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "Swelling but it was very sensitive to the touch"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "discomfort I felt on the left arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Consumer stated, "I went to my doctor prior to the first injection and I got an MRI of my brain which I annually get and it said there was no change and I was okay to get the shot and I also went to my internal medicine doctor for the blood pressure and he also said it would be okay. So, there is on file, I did a blood work for my internal medicine and the MRI for my brain! my MS doctor that was maybe, the date I got the first shot was on. On 8Aug and I think I went maybe the week before and had the MRI done. No follow-up attempts are possible. No further information is expected.
Narrative: COVID infection following COVID vaccine series 02/23, Pfizer, dose #1 03/16, Pfizer, dose #2 09/10, Pfizer, dose#3 09/15 pt cc: cough, diarrhea, fatigue, headache, loss of taste or smell, rhinorrhea exposure: unknown 09/17 SARS-COV-2 Variant Sequencing result: pending 10/29 COVID swab, result: detected
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown ages and genders with no pertinent medical history and no drug allergies or reactions reported. On an unknown date, the patients received an improperly stored dose of (Oka/Merck) VARIVAX, 0.5 ml, subcutaneous exposed to 23.9F for 103.58 hours (lot# and expiration date were not reported). There was no concomitant therapy reported. No adverse effects were reported. It was unknown if the patients sought medical attention. Additional information has been requested.
This spontaneous report was received from a health care worker regarding a 4 year old patient of unknown gender. Information on the concurrent conditions, medical history and drug allergies of the patient was not reported. On 15-APR-2016, the patient was vaccinated with improperly stored dose of M-M-R II (dose number, dose, frequency, route and anatomical location, lot number and expiration date were not specified). Concomitant medication were not specified. There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
ABDOMINAL PAIN; BRUISED ON ARM AND LEG; TINGLING ON LEFT SIDE; NUMBNESS ON LEFT SIDE; ARM HURTING/LEG PAIN/IRRITATING PAIN ON THE LEFT LEG THE SIDE WHERE SHE RECEIVED THE SHOT; This spontaneous report received from a patient concerned a 60 year old female. 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 (dose number in series 1, unspecified manufacturer) (suspension for injection, route of admin not reported, batch number not reported) dose was not reported,1 total, administered on 10-APR-2021 for prophylactic vaccination. No adverse events reported following initial dose of vaccination (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822811 and expiry: UNKNOWN) dose was not reported,1 total, administered on 11-DEC-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 11-DEC-2021, the patient experienced  arm hurting, leg pain and irritating pain on the left leg the side where she received the shot. On 12-DEC-2021, the patient experienced tingling on left side and numbness on left side. On 13-DEC-2021, the patient experienced bruised on arm and leg. On an unspecified date, the patient experienced abdominal pain (all events dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm hurting/leg pain/irritating pain on the left leg the side where she received the shot, tingling on left side, and numbness on left side, and had not recovered from bruised on arm and leg, and abdominal pain. This report was non-serious.
She had a full body rash from head to toe that lasted for 3 days.; The lymph nodes on all over her body became enlarged.; Her lymph nodes in neck were swollen after receiving 1st dose.; did not get second dose; This spontaneous case was reported by a consumer and describes the occurrence of RASH (She had a full body rash from head to toe that lasted for 3 days.), LYMPHADENOPATHY (The lymph nodes on all over her body became enlarged.), LYMPHADENOPATHY (Her lymph nodes in neck were swollen after receiving 1st dose.) and PRODUCT DOSE OMISSION ISSUE (did not get second dose) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026M21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020. Concomitant products included PROPRANOLOL for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced LYMPHADENOPATHY (Her lymph nodes in neck were swollen after receiving 1st dose.). On 21-Mar-2021, the patient experienced LYMPHADENOPATHY (The lymph nodes on all over her body became enlarged.). On 01-Apr-2021, the patient experienced RASH (She had a full body rash from head to toe that lasted for 3 days.). In 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not get second dose). The patient was treated with PREDNISONE from March 2021 to March 2021 at an unspecified dose and frequency. On 04-Apr-2021, RASH (She had a full body rash from head to toe that lasted for 3 days.) had resolved. In 2021, PRODUCT DOSE OMISSION ISSUE (did not get second dose) had resolved. At the time of the report, LYMPHADENOPATHY (The lymph nodes on all over her body became enlarged.) and LYMPHADENOPATHY (Her lymph nodes in neck were swollen after receiving 1st dose.) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Added Historical condition, event, updated reporter details and narrative was updated accordingly.
Covid arm starting 7.5 days after 1st dose with systemic itching, especially of ears and rash.  Increased muscle weakness and pain.
16 min post Moderna COVID vaccination pt complained of nausea, dizziness, and headache.  No s/s of anaphylaxis including no respiratory distress, urticaria, or angioedema.  21 min post vaccination patient given 12.5 mg diphenhydramine IM in opposite arm of injection.  35 min post vaccination and after no improvement of symptoms pt given another 12.5 mg of diphenhydramine IM.  Pt under continuous observation by RN with normal O2 and HR but with BP ranging from 156/102 - 192/92.  During the entire observation no s/s of acute anaphylaxis.  Pt denies history of hypertension and denies medication for hypertension. 42 min post vaccination patient symptoms continued and reports chest tightness but no respiratory distress and normal O2.  EMS called for transport to hospital.  45 min post vaccination EMS arrived and patient transported to hospital.
Past history of high fever and perioral cyanosis with MMR dose #1 given  at 1 year old. Less than 30 minutes after pt received her MMR vaccine #2 on 1/18/19, her mother brought her back into the clinic to report she had vomited as she was getting into their car. Pt appeared pale, was clammy to the touch and vomited x1. She was afebrile, steady pulse, and regular, non-labored respirations. She had no facial swelling or rash.
Information has been received from a registered nurse concerning a 53 year old male with immunosuppression, hepatitis C, cocaine abuse and no known drug allergies who on 09-JAN-2007 was vaccinated intramuscularly in the left deltoid with a 0.5 mL dose of Pneumovax 23 (Lot # 655499/0988F).  Concomitant therapy included interferon alfa, ribavirin, hydrocortisone, loratadine, WELLBUTRIN and BENADRYL.   One hour after vaccination, the patient reported that the injection site was painful.  On 10-JAN-2007, the patient reported the injection site as painful, red, swollen, and warm.  The patient was examined on 11-JAN-2007 and the injection site was still painful, red, swollen, and warm but much better than on 10-JAN-2007.  There was no infection noted at the injection site on 11-JAN-2007 but the patient was placed on KEFLEX prophylactically.  No laboratory diagnostic studies were performed.  On 11-JAN-2007, the patient was reported as recovering.  No product quality complaint was involved.  Additional information has been requested.
Very cold, very very nauseous, very weak and tired but restless/couldn't sleep, heart rate normal but 95-100 while lying in bed for 2 hrs (usual HR: 63), overall ill feeling and mild joint pain.
Patient presented to the office for administration of Moderna Bilvalent Vaccine. However when documenting the administration of the vaccine 3 hours later, it was noted that the incorrect vaccine was pulled and administered. The patient received a monovalent booster dose instead of the bivalent booster dose.  CDC was contacted and after discussing with the CDC, the patient was notified of the error and that they will be eligible for a bivalent booster dose in 2 months.  The patient remained in office for 15 minutes post vaccination and did not experience any adverse reactions during that time.
Body aches; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, PAIN (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue) had not resolved.            Concomitant medication was not provided.  Treatment information was not provided.
Late PM after receiving injection around 11:45 AM of the same day, hands itching/red/burning/rash-macular. Woke at 4 AM with burning/itching-No meds to tx-Returned to clinic at 8 AM given ZYRTEC 10 mg, TRIAMCINOLOE 0.1% cream to use BID.