chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chief Complaint Patient presents with ? Breathing Problem     pt is covid + 01/09/22, states "I have copd & i feel like I cant breathing right now"  spO2 90% in triage     HPI  63-year-old female with past medical history of COPD, hypertension, dyslipidemia who presents with shortness of breath which has been worsening.  Patient states symptoms started originally after the end of December and she did see her primary doctor for this who started her on a short steroid course.  Patient states she completed the course with little relief of her discomfort.  She does have a pulmonologist who she is scheduled to see soon.  Patient states that since that time she has had some chronic shortness of breath but it seemed to worsen over the last couple days.  Patient states she does not use oxygen via nasal cannula at home but felt extremely short of breath today.  Of note, the patient does admit that she tested positive for Covid on 01/09/2022.  She did appropriately quarantine.  She is not had any fevers, sweats or chills in the last few days.  She denies any lightheadedness or dizziness.  She admits to normal p.o. intake with normal stooling and voiding and no blood in either.  She denies any urinary symptoms.  She otherwise denies any other complaints.     Review of Systems  Constitutional:  No fevers or chills.  Eyes:  No visual changes or discharge. ENMT:  No ear or nasal discharge. No neck pain or stiffness. Cardiac:  + chest pain with cough, + SOB, no edema.  Respiratory:  + cough or respiratory distress.  GI:  No nausea, vomiting, diarrhea or abdominal pain. GU:  No dysuria, frequency or burning. MS:  No edema or pain. No back pain. Neuro:  No headache or weakness.  No LOC. Skin:  No skin rash.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 22-OCT-2015 22:06, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 4.5 and -2.5 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
What I describe is not an adverse effect, but I am thinking it might be useful for you to know that I have an unexpected positive outcome that might be of use(?) to some of the long haulers who have been struggling with issues since getting covid19.  Before I got very sick from the 2nd vaccine (muscle aches, fever for 24hrs, headache a bit longer) I had sore muscles for months/years - coworker MD thought it was from rheumatoid arthritis, never got it diagnosed, but it was leaving me weaker and more achey every month.  After 2nd vaccine I have noticed that my legs are not so achey; indeed, they are much better.  It is very weird and so far so good.  Perhaps if the long haulers receive immunization, it will have some positive effect on their depressions, inflammations that are lingering.  I did not expect this good effect.  (I also did not expect to be in the 10% who got more severe effects from the 2nd vaccine.).
Pt had a syncopal episode post vaccination. Pt recovered after 30 min of rest.
Patient scheduled for COVID- 19 vaccine in error for 2nd dose however not due until 7/6/2021. 2nd dose administered after 2 weeks versus 3 weeks, 3 days prior to 4 - day grace period. No adverse effects noted thus far.
Red skin across breast, at first looked like sunburn. After about a month rash had spread all across mid section back and shoulders- extremely itchy
Red Bumps on arms and legs with fever. Upon waking in the morning Bumps had spread out and changed to flat scaly open sores along with fever.
presented with SOB; fever, body aches, sore throat;  + Covid at home PTA; Admit 9/24 to tele with Covid PNA; tx with : 9/24 steroids, 9/25 vit C, Rocephin, Vit D3, doxycycline, lovenox, singulair, zinc O2 requirements: 2-4 LPM throughout; home on O2
severe headache; exhausted; fever; chills; feel achy; This is a spontaneous report received from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch Number: EN6204), via an unspecified route of administration in the left arm on 12Mar2021 at 10:45 (at the age of 42-years-old) as a single dose for COVID-19 immunization. Concomitant medication included Spironolactone, clonazepam, quetiapine, desvenlafaxine for unknown indication, from unknown-to-unknown date, unknown if ongoing. Prior to vaccination, the patient had not diagnosed with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. The patient experienced feel achy, exhausted, chills, fever of 103-104, severe headache on 13Mar2021. No Therapeutic measures were taken as a result of adverse events. The clinical outcome of the events achy, exhaustion, chills, fever and headache were unknown. No follow-up attempts are needed. No further information is expected.
approx 1/2" abcess on RLT concurrent w/site of immun; parent reports no fever, redness & none seen on exam; parent described moderate fussiness p/immun, but no other signs of pain; instructed warm packs, bath x 1 wk;
pt recv vax & 30min post vax pt devel a h/a;MD indicated that 8 other pt had similar exp (WAES97100694, 97100696 & 97100698 through 97100703);
Numbness. Tingling sensation. Pain. Restricted arm movement (Can't move arm as much).
having a very bad experience; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events having a very bad experience.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unk) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) having a very bad experience.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), having a very bad experience was unknown.
11/7/2022 I had a violent shaking on the inside of my body. I guess it was my heart or pulse and it was shaking my body. This lasted off and on along with my irregular heartbeat for a couple of hours. I went to the emergency room. I was hooked up to an EKG and had blood work. I was told I had A Fib. This could be related to Lyme's disease I had in the 90's. I was hospitalized. I was on an IV with medication that lowered my blood pressure really low. I am not sure what the medication was. My ELIQUIS and metoprolol were increased. I was released the next day. Since then, my heartbeat is briefly irregular.
Aches, weakness, chills, fever, night sweats.  These flu like symptoms were episodic with worse on 19 and 20 October.  Large red area in vicinity of shot...3 inch radius that persisted 10 days.
Smallpox vaccination,Anthrax #1, Typhoid,Hepatitis B #2. 24 July 2003 Received primary smallpox vaccination in his left arm via 3 jabs.  No contraindications to smallpox.  Received the smallpox briefing and brochure.Also received the other 3 vaccinations in his right arm.  He had no complaints on this day ("felt fine").   2 Aug 2003 Started developing fever (subjective) and chills alternating with sweats.  "Didn't feel up to normal activities."  "Felt dehydrated."  Mild to moderate headache.  No vision changes.  No neck discomfort.  No chest pain or dyspnea.  Vaccination site had slight drainage and there was erythema starting to develop around smallpox vaccination site (approximately 1 inch).No complaints regarding vaccination sites in right arm.  3 Aug 2003 Continuation of flu-like symptoms and erythematous circle growing around site.  Now noted that the erythematous circle had expanded around shoulder and to approximately 3 inches above elbow.  Noted tenderness under left arm-"it felt tight if I moved my arm."  8/4/03 Flu-like symptoms decreasing but noted increasing erythema and had extended to approximately 2 inches from elbow.  Area not pruritic.  Smallpox vaccination site with slight drainage.  Presented to the clinic for evaluation.  MD referred. He was diagnosed with having a robust take, prescribed Ibuprofen, Tylenol, and Benadryl, and referred to another MD.  8/5/03 Evaluation.  Flu-like symptoms almost completely resolved.  Reports erythema is "lighter" but now has extended down to antecubital area.  Had not noted any other lesions but then at visit, noted several erythematous macular-papular lesions on chest and back.  Non-pruritc.  Denies noticing these lesions previously and does not remember ever having these lesions in previous episodes. Diagnosed with Robust take and Non-viral pustulosis.
muscular pain, chest pain & muscular rigidity;pain in the entire body, fever, diarrhea & nausea;
got her second dose past the six month on 01/21/2020; Chills; Sweats; feeeling sick / malaise all over her body; fatigue; below her breast, on the rib cage there is a feeling of prickling; below her breast, on the rib cage there is a feeling of itching; This case was reported by a consumer and described the occurrence of chills in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (For tolerance after 1st dose refer case US2019063128).   On 21st January 2020, the patient received the 2nd dose of Shingrix (intramuscular). In January 2020, less than 2 weeks after receiving Shingrix, the patient experienced chills, sweating, feeling unwell, fatigue, tingling and pruritus. On 21st January 2020, the patient experienced drug dose administration interval too long. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the chills, sweating, feeling unwell, fatigue, tingling and pruritus were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the chills, sweating, feeling unwell, fatigue, tingling and pruritus to be related to Shingrix.  Additional details were reported as follows: The patient received 2nd dose of Shingrix vaccine and experienced chills, sweats, feeling sick, fatigue, and malaise all over her body. She also reported on the left side, below her breast, on the rib cage there was a feeling of prickling and itching. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The patient consents to followup with HCP
Received 0.2 mL of non-Diluted COVID-19 Pfizer 5-11yr solution; vaccine was not Diluted in advance. No symptoms reported or adverse effects.
Brief syncopal event fell and hit head,  immediately regained consciousness, episode was about 1 minute long patient was lying flat on the ground when she regained consciousness
This spontaneous report as received from a pharmacist refers to a 77 year old male patient. The patient did not have concurrent conditions, medical history or concomitant medications. There was no information about any patient's known allergies or reactions. On 02-JAN-2017, the patient was vaccinated with the first dose of RECOMBIVAX HB, for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On 02-FEB-2017, the patient was vaccinated with the second dose of RECOMBIVAX HB, for prophylaxis (dose, route of administration, lot number and expiration date were not reported).      On an unspecified date, the patient experienced an unspecified medical condition (adverse event). Then, due to the event, the patient sought medical attention. Therefore, on approximately 02-MAR-2017 (reported as "one month after" administration of the second dose of the vaccine), "the patient was given a blood transfusion for an unspecified medical condition" (adverse event). However, it was unknown if the "unspecified medical condition" started, on an unspecified date in 2017 before or after first and second dose of RECOMBIVAX HB. The pharmacist believed that the patient might had been hospitalized on an unspecified date in 2017; however, did not have any information in regards to the hospital details. Subsequently, on 14-JUN-2017 after the patient's blood transfusion, the patient was vaccinated with the third dose of RECOMBIVAX HB lot # M023892 expiration date of 15-SEP-2017, for prophylaxis (dose and route of administration were not reported). The outcome of the unspecified medical condition (adverse event) was reported as recovered, on an unknown date in 2017. The causal relationship between the event and therapy with RECOMBIVAX HB was not reported. No product quality complaint was involved. Upon internal review the event of unspecified medical condition was considered to be medically significant since the patient received a blood transfusion. Additional information has been requested.
Fatigue; Nausea; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "asthma" (unspecified if ongoing); "cholesterol high" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing). Concomitant medication(s) included: RSV VACCINE taken for immunisation, start date: 10Oct2023, stop date: 10Oct2023; FLU [INFLUENZA VACCINE] taken for influenza immunisation, start date: 26Sep2023, stop date: 26Sep2023; LISINOPRIL; CHLORTHALIDONE; ROSUVASTIN. Past drug history included: Ciprofaxen, reaction(s): "Drug allergy"; Phenobarbital, reaction(s): "Drug allergy". Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 18Oct2023, outcome "recovered" (Oct2023); HEADACHE (non-serious) with onset 18Oct2023, outcome "recovered" (Oct2023); NAUSEA (non-serious) with onset 18Oct2023, outcome "recovered" (Oct2023). Therapeutic measures were not taken as a result of fatigue, nausea, headache.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
chills; fever; aches; fatigue; mouth and throat ulcers; mouth and throat ulcers; swollen lymph nodes; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0162) via an unspecified route of administration in the left arm on 13Apr2021 at 21:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included history of parotid gland cancer, fully recovered and treatment over 15 years ago. The patient had known allergies to penicillin and sulfa drugs. Concomitant medications included sertraline (MANUFACTURER UNKNOWN) and birth control; both taken from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the left arm on 23Mar2021 at 10:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 15Apr2021, the first 48 hours, the patient experienced chills, fever, aches and fatigue. The patient also experienced mouth and throat ulcers, swollen lymph nodes, chills, fatigue - still after an entire week. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken as a result of the events mouth and throat ulcers and included treatment with magic mouthwash prescription. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, fever, aches, fatigue, mouth and throat ulcers and swollen lymph nodes were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
DKA; A spontaneous report was received from a physician concerning a male patient, who experienced diabetic ketoacidosis (DKA).     The patient's medical history included pre-diabetes. Product known to have been used by the patient included metformin.   On 08 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) for prophylaxis of COVID-19 infection.  ON 02 Feb 2021, the patient presented to the hospital with DKA. He had no obvious precipitating factors like infection, steroids, cardiac issues per endocrinologist. Patient is due to get his second dose on 15 Feb 2021. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome for the event was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time. The patient's medical history of pre-diabetes is a risk factor and confounds causality. Further information has been requested.
I did not notice that the vaccine had been mixed 01/27/2022 so it was expired by 24 hours.
pt recvd vax; febrile last noc (t 104.6); inject site ok, apap given bringing t down to 103.5;
2 months old male who developed purple discoloration with swelling from the umbilical downward involving both extremties. Pt. was examined at hosp. ER it was determined Rx was 2 hours to DTaP uncomfortable crying for more than 3 hours.
t105 temp would not respond to APAP; pt had unusual crying, then lethargy & moaning was taken to ER 8AM on 18NOV93 pt had also begun having SOB; MD & informed parent appeared to be reaction to pertussis; t104 @ ER;
Patient slumped into chair in the observation area. I rushed to her. She was hyperventilating, but not wheezing or making any high pitched sound while breathing. Patient was conscious, and could answer my questions coherently. Patient was told to take off her mask so she can breath more easily. Patient kept saying "I'm sorry" and was told there's nothing to feel sorry for, and we wanted to make sure she was fine. Pulse was slightly elevated. Hands were warm and sweaty. Patient asked for a bottle of water. After drinking some water she felt better. It was likely a panic attack episode. I checked on her five minutes later. She just finished talking on the phone with a family or friend. She was a lot better at this point. She agreed that that was likely a panic attack. I advised her she should be able to receive the 2nd dose later, but should consult her PCP.
3 hours after I received the vaccine I had vaginal spotting. I NEVER, not even once in my life, between periods have experienced spotting. It lasted for a few hours.
KINRIX vaccine was given for 2nd and 3rd dose DTaP and 2nd and 3rd dose polio. This was noted upon review of immunization record for school entrance. CDC consulted - doses are valid. Letter R/T incident mailed to vaccine administrator.
Experiencing diarrhea beginning approximately 36 hours after the booster and persisting for at least 48 hours.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history, concurrent condition and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # M004116 with expiration date 12-OCT-2017, or lot # L028083 with expiration date 03-SEP-2017, or lot # L040164 with expiration date 20-FEB-2018, or lot # L045700 with expiration date 22-FEB-2018, dose and route not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected because we are not allowed to contact the reporter.
positive for Covid 19; positive for Covid 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2022 at 16:45 as dose 3 (booster), single (Lot number: FK9894) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 23Oct2021 at 15:00 as dose 2, single (Lot number: 012F21A), in left arm for covid-19 immunisation; jnj 78436735 (COVID-19 VACCINE NRVV AD26 (JNJ 78436735)), on 04Apr2021 at 09:30 as dose 1, single (Lot number: 043A21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "comorbidity: obesity" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "not recovered" and all described as "positive for Covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive; (25Jun2022) Negative, notes: Day 9; (27Jun2022) Positive, notes: Day 11. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: After testing positive for Covid 19, the patient started Paxlovid within hours of the positive test (Day 0 of symptoms). The patient took the full dosage as prescribed (3 pills, 2x a day, for 5 days.) The patient symptoms (sore throat, stuffy head, digestive issues, and fatigue) disappeared by Day 6 and the patient tested negative on Day 9. A few symptoms (sore throat, stuffy head, and fatigue) returned on Day 10 (26Jun2022 17:00) and the patient was tested positive again on Day 11. The adverse event was not resulted in emergency room or physician office visit.
Patient has had a red rash for 4 days. It was first noticed on the right leg. Got shots with PROQUAD and DTAP on Thursday and then the redness and swelling started on Friday and has not spread. He has not had this rash before.
On 7JUL pt began running fever of 102, on 8JUL tem was 104, on 9JUL temp 105 mom gave pt APAP; Also exp vomiting & nausea; Taken to MD on 10JUL w/crying & vomiting;
HIGH FEVER, CHILLS FOR 2 DAYS FOLLOWING VACCINE.. STILL HAVING HEADACHES AND MUSCLE PAINS
This spontaneous report was received from a pharmacist and refers to an unspecified number of patients of unknown age and gender. No medical history or current condition were reported. Starting from 12-NOV-2015, an unspecified number of patients were administered with improperly stored doses of GARDASIL (lot number-K006960, expiry date 19-FEB-2007 and lot number-K008931, expiry date-04-MAR-2017) (dose, route were not reported). No adverse event was reported. No further information was provided. This is one of two reports from the same reporter. Additional information has been requested.