chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Took Meningococcal Vaccine on last Friday (11/30/2018) on the left arm. Since then developed purplish rash around the same place where he took the shot. It was small in the beginning but now has grown big to the size of my palm and feels itchy. It is been more than 7 days since the shot was taken.
upset stomach; light fever; feeling nausea; having chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach), PYREXIA (light fever), NAUSEA (feeling nausea) and CHILLS (having chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced ABDOMINAL DISCOMFORT (upset stomach), PYREXIA (light fever), NAUSEA (feeling nausea) and CHILLS (having chills). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach), PYREXIA (light fever), NAUSEA (feeling nausea) and CHILLS (having chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.
Patient did not have any type of reaction. Patient received the wrong dose for his age group during his first COVID vaccine. Patient later came in for his second dose and received the proper dosing for his age.
27JUL93 injections given; 28JUL93 temp to 106 ax dec intake 29JUL93 returned to office lost 8oz in 2 days; cont amox -APAP a/w advil called p/home few hrs; no appetite;
had bleeding at injection site, thought they hit a vein, and with in a minute or 2 it swelled up very large, and maybe 5 minutes later face was flushed and breaking out in hives, put ice on injection site and gave me 50 mg of Benadryl which started working quickly with in maybe 5 or 10 minutes, felt flushed, blood pressure spiked to 162/92 , went to Hospital emergency room, arrive by 1:50 pm and was very shaky/cold/ feeling numbness in hands, ER gave me pepcid intravenously and some fluids and by 2:45 was feeling better, was released from ER by 4:30
Fever; Chills; Nausea; Headache; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the right arm on 28Mar2021 at 13:30 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism (Hypothyroid), multiple sclerosis (MS) and Penicillin allergy. Concomitant medications included methylphenidate hydrochloride (RITALIN); baclofen (MANUFACTURER UNKNOWN); aciclovir (ACYCLOVIR); ergocalciferol (VITAMIN D2) and estradiol (MANUFACTURER UNKNOWN) all for an unknown indication, from an unknown date. 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. Since the vaccination, the patient had not been tested for COVID-19.  On 28Mar2021 at 18:00 the patient experienced fever, chills, nausea, headache and body aches. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with (TYLENOL) and (MOTRIN) on an unknown date in 2021. On an unknown date in 2021, the patient underwent lab work, chest X-ray for the events and the results were unknown. The clinical outcome of the events fever, chills, nausea, headache and body aches were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Eye inflamed; Worn out; This spontaneous case was reported by a consumer and describes the occurrence of EYE INFLAMMATION (Eye inflamed) and FATIGUE (Worn out) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis and Panuveitis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced EYE INFLAMMATION (Eye inflamed) and FATIGUE (Worn out). At the time of the report, EYE INFLAMMATION (Eye inflamed) and FATIGUE (Worn out) outcome was unknown.            Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  On unknown dates, the patient experienced eyes got inflamed close to when it was time for Humira injection and patient was wore out. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 03-MAY-2017, the patient was vaccinated with an improperly stored dose with PROQUAD lot # M043308, expiration date: 24-APR-2018,  as prophylaxis (Strength. dose and route were not reported), which experienced a temperature excursion of 15 Fahrenheit degrees for 3 hours and 30 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. The patient's concomitant therapies included sterile diluent (manufacturer unknown). Additional information has been requested.
Narrative:  80 yo male patient with PAST MEDICAL HISTORY: 1 htn 2 gerd/hiatal hernia 3 h/o ckd 3 in past? 4 hyperlipidemia 5 s/p hemorrhoid surgery 2002 6 cscope 2007 outside facility 7 h/o elevated psa, biopsy done in past, no cancer per patient report 8 s/p tonsillectomy childhood 9 chronic back pain, severe degen change on plain x-rays Received covid vaccines on 2/2/21 & 3/3/21. Pt died of unknown causes & unknown place on 12/26/2021. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 at 09:00 as dose 1, single (Lot number: ER8734), in right arm and on 22Apr2021 at 15:00 as dose 2, single (Lot number: ER8731) at the age of 37 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 17Nov2021 at 12:00 as dose 3 (booster), single (Lot number: 091D21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "no" (unspecified if ongoing), notes: Other medical history: No. Concomitant medication(s) included: ADDERALL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Had a very faint positive line at-home test yesterday and a much more prominent positive line at-home test today; Positive, notes: Had a very faint positive line at-home test yesterday and a much more prominent positive line at-home test today. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Anti-viral details: product: COVID 19 Treatment Paxlovid, Treatment start date: 27Apr2022, Treatment stop date: 01May2022, Indication: Treatment of COVID-19. Other medication details: other medication in 2weeks product: Adderall. Adverse event: patient started the Paxlovid Wed evening and finished the 5 day course. My symptoms got much better over the next two days and were fully resolved by Sunday. They came back last night, basically exactly the same ones patient had when patient first got sick. Had a very faint positive line at-home test yesterday and a much more prominent positive line at-home test today.  No follow-up attempts are possible. No further information is expected.
Fever within 24 hours. Lowered state of consciousness within 48 hours of administration that lasted several days. Personality changed. Speech diminished. It was as though patient had been hit with a tranquilizer.
Patient experienced weakness; BP 159/91, HR 102. Gave water - patient did not take BP medications. After water, patient felt better, and was safe for home discharge. MD speculated about vasovagal reaction.
Headache and lightheadedness 15 min post vax Observation, fluids, food Sxs resolved after 10 mins of close monitoring NKA
got Pfizer vaccine yesterday at the vaccination clinic.  Last night developed hives on his back, relief with cold compresses and Benadryl.  Saw pcp today and received steroid shot.  PCP instructed caller to get a different vaccine, specifically johnson and johnson.
patients who have been vaccinated (unsure of which Covid-19 vaccine or vaccines) and that many of them test positive afterwards,; patients who have been vaccinated (unsure of which Covid-19 vaccine or vaccines) and that many of them test positive afterwards, many of them are positive with the variants of Covid-19; The initial case was missing the following minimum criteria: ICH unspecified no. of patients. Upon receipt of follow-up information on 13Aug2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (Patient). A 57-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown) via intramuscular, in the left arm (left shoulder) on Mar2021 at 12:00 (at the age of 57-years-old) as dose 2, single and dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown) via intramuscular, in the left arm (left shoulder) on Feb2021 at 11:00 (at the age of 57-years-old) as dose 1, single for covid-19 immunisation. Vaccination facility type was military base. The patient medical history and concomitant medications were none. The patient did not receive any vaccines within four weeks prior to the vaccination. Caller stated that patients who have been vaccinated (unsure of which covid-19 vaccine or vaccines) and that many of them test positive afterwards, (drug ineffective and sars-cov-2 test positive). Although fully vaccinated patient became severally infected with Delta Covid variant, within 6 months of vaccinations. Patient had no reactions to the vaccine when given. Seriousness criteria reported persistent, significant disability, incapacity, important medical event. The patient did not receive any treatment for the event. Adverse event required visit to emergency room. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. Outcome of the events was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Sender's Comments: Linked Report(s): US-PFIZER INC-202100942252 Same reporter, drug and different patient, event.
Imm 8:50, 9:20 inj site red, raised, 9:30 inj site doubled in size, rash, red, raised on legs and abd. Diphendramine given, post 20 minutes redness and rash gone inj site red and raised.
SHORTNESS OF BREATH; BLURRED VISION; LEG SWELLING; TACHYCARDIA; EASY BRUISING; LEG PAIN; HEADACHES; INJECTION SITE PAIN; WEAKNESS; This spontaneous report received from a patient concerned a 48 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 (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for drug used for unknown indication.  On 28-MAY-2021, the subject experienced shortness of breath. On 28-MAY-2021, the subject experienced blurred vision. On 28-MAY-2021, the subject experienced leg swelling. On 28-MAY-2021, the subject experienced tachycardia. On 28-MAY-2021, the subject experienced easy bruising. On 28-MAY-2021, the subject experienced leg pain. On 28-MAY-2021, the subject experienced headaches. On 28-MAY-2021, the subject experienced injection site pain. On 28-MAY-2021, the subject experienced weakness. On 06-JUN-2021, Laboratory data included: Duplex ultrasound (NR: not provided) Negative. Treatment medications (dates unspecified) included: tramadol, and naproxen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, blurred vision, tachycardia, easy bruising, headaches, injection site pain, and weakness, and had not recovered from leg pain, and leg swelling. This report was non-serious.
did not feel weell; TSH had dropped / TSH level to drop.; This case was reported by a consumer and described the occurrence of malaise in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 7 days after receiving Shingrix and an unknown time after starting Levothyroxine, the patient experienced malaise and thyroid stimulating hormone decreased. The patient was treated with thyroxine sodium (Levothyroxine). On an unknown date, the outcome of the malaise and thyroid stimulating hormone decreased were unknown.   It was unknown if the reporter considered the malaise and thyroid stimulating hormone decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that the Shingrix vaccine caused TSH level to drop.  The patient received Shingrix and did not feel well and TSH had dropped and would not get the second one. The patient takes Levothyroxine for thyroid.  The week before the vaccine the level was good.
fever 100.2, h/a, muscle aches, sore all over; swelling @ inj site w/o rxn of redness;
Facial paralysis; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Facial paralysis) in a male patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FACIAL PARALYSIS (Facial paralysis) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Facial paralysis) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Fainted in the night; Patient's husband found her on the bathroom floor; Felt quiet poorly as if she had the flu; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted in the night) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Fainted in the night) (seriousness criterion medically significant), FALL (Patient's husband found her on the bathroom floor) and FEELING ABNORMAL (Felt quiet poorly as if she had the flu). At the time of the report, SYNCOPE (Fainted in the night), FALL (Patient's husband found her on the bathroom floor) and FEELING ABNORMAL (Felt quiet poorly as if she had the flu) outcome was unknown.            No concomitant medication were reported.   No treatment information were provided.    Reporter reported she was getting the 4th shot until a close friend had an experience with the Moderna vaccine who was same age as the caller.  Company Comment: This spontaneous case concerns a 72-year-old female patient with no medical history reported, who experienced the unexpected (listed in US factsheet and US PI) serious (medically significant) event of Syncope and non-serious events of Fall and Feeling abnormal unspecified days after a dose (second booster) of mRNA-1273 vaccine. It was reported that Patient fainted in the night after getting the 2nd booster dose as she was walking to the bathroom. The patient's husband found her on the bathroom floor, and she felt quiet poorly as if she had the flu but felt ok after taking care of herself day after next. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-572766 (Patient Link).; Sender's Comments: This spontaneous case concerns a 72-year-old female patient with no medical history reported, who experienced the unexpected (listed in US factsheet and US PI) serious (medically significant) event of Syncope and non-serious events of Fall and Feeling abnormal unspecified days after a dose (second booster) of mRNA-1273 vaccine. It was reported that Patient fainted in the night after getting the 2nd booster dose as she was walking to the bathroom. The patient's husband found her on the bathroom floor, and she felt quiet poorly as if she had the flu but felt ok after taking care of herself day after next. The benefit-risk relationship of mRNA-1273 is not affected by this report.
she got sick to her stomach; Did not feel good; Threw up once; Was really tired; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (she got sick to her stomach), FEELING ABNORMAL (Did not feel good), VOMITING (Threw up once) and FATIGUE (Was really tired) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   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) (unknown route) dosage was changed to 2 dosage form. On 04-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (she got sick to her stomach), FEELING ABNORMAL (Did not feel good), VOMITING (Threw up once) and FATIGUE (Was really tired). On 06-Mar-2021, ABDOMINAL DISCOMFORT (she got sick to her stomach), FEELING ABNORMAL (Did not feel good), VOMITING (Threw up once) and FATIGUE (Was really tired) had resolved.            No Concomitant medications were provided by the reporter. No Treatment History was provided by the reporter.   This case was linked to MOD-2021-031902 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up information received on 24 May 2021 does not contain any new information
Went to bathroom and it was all blood/Filled the toilet with blood/Blood in urine; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATURIA (Went to bathroom and it was all blood/Filled the toilet with blood/Blood in urine) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HAEMATURIA (Went to bathroom and it was all blood/Filled the toilet with blood/Blood in urine). At the time of the report, HAEMATURIA (Went to bathroom and it was all blood/Filled the toilet with blood/Blood in urine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment and concomitant medications were reported.
NO treatment needed, vaccine was given by mistake. Doctor order MMR and Varicelle was given.
Patient here for a Hep B vaccine and accidentally recieved a Hep A vaccine.
slept most of the day p/recvd vax 17AUG92 & the early Am the day p/vax 18AUG92 awakened easily for feedings but drowsy, pale, no excessive crying;
Pt had moderna vaccine around 17:20, pt c/o itchy around neck and 1 small rash @neck (left side) during 30 min observation. Doctor was called . Zyrtec 10 mg po given at 5:35pm as Doctor order. 5:45 VS stable BP 118/74, P: 82, O2sat 100%, resp: 16   5:55- pt stated she feel better and pt want to go home, pt verbalized understand to go to ED if symptom getting worse
Severe diarrhea began 5:15 PM to 5 AM took 7 IMODIUM during night fever to 100 degrees  - chills - cramps - arm hurts (still hurts 11/10/10).
facial numbness, B/P- 130/77, P- 58; clearedby EMS
Patient and wife called in to report patient experiencing 7/10 constant stomach pain, uncontrollable shaking, and numbness and tingling bilateral feet. Patient reports receiving his first covid vaccine dose 2-17-21 and experiencing symptoms, today Patient states, "I can't feel the bottoms of my feet" and "it feels like I'm going to throw up". Patient denies difficulty breathing. Patient was able to check pulse will on phone with triage nurse with pulse 93 and blood pressure 147/107. Patient requesting to have triage nurse call 911-EMS; HPI  The patient is a 69 year old male who states that he had the 1st dose of COVID vaccine yesterday morning.  The patient states that approximately 24 hours later, he developed stomach cramping.  He has nausea.  He denies any diarrhea.  He has not vomited.  Patient denies any cough or shortness of breath.  He complains of generalized weakness.  The patient also has chronic back pain.  Patient is noted to have a low-grade fever here, however, he does not report any fever. CHIEF COMPLAINT: WEAKNESS (per ems, pt got covid vaccine 24 hours ago, feeling weak and dizzy since 1500, tachycardia); Assessment/Plan DIAGNOSIS at time of disposition: 1. Hepatitis; The patient presents with a low-grade temperature, which isn't unexpected given that he received his COVID-19 vaccine yesterday.  However, the patient complains of abdominal pain.  Lab work does show elevated bilirubin, alk-phos, AST and ALT.  The patient has no previous history of this.  I did obtain both CT and ultrasound imaging of the gallbladder, which shows no pathology.  Subsequently, the patient was reassessed.  He is ambulated.  He is steady on his feet.  He does not desaturate.  He has no subjective complaints while walking.  I discussed the patient's lab abnormalities with him.  The patient prefers to go home and follow up for lab retesting on Monday.  Patient was given strict return instructions.  He will return should he develop any new or worsening symptoms.  He is going to have his labs redrawn on Monday and follow shortly with his primary care provider.  Given the normal imaging studies, I do think that these findings are likely related to a reaction to his vaccination.  This was discussed at length with the patient.  Patient is discharged home in stable condition.