chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme exhaustion; pain at injection site; headache; dizziness; sore throat; Seeing spots; Breath fog; This is a spontaneous report received from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER3789) via an unspecified route of administration in the left arm on 26Mar2021 at 15:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. It was reported that patient received unspecified medications within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in 2021, the patient experienced extreme exhaustion, pain at injection site, headache, dizziness, breath fog, was seeing spots, and sore throat. The adverse events did not result in doctor or other healthcare professional office/clinic visit, or emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of events extreme exhaustion, pain at injection site, headache, dizziness, breath fog, seeing spots and sore throat was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Parent stated child experienced nausea and lethargy beginning 8/22/2007 and persisted for one week. An appointment was scheduled with her primary care provider, Dr., who drew blood and sent child for an abdominal x-ray.  Per MA at Dr's office, results were within normal limits.
Sore arm, Fever (103 degree), bumps on tongue (painful), tongue and cheek  swelling, roof of mouth swelling, sore gum. Diagnosed with Glossitis. Prescribed steroids, pain medication, and Benedryl. Also prescribed Dexamethasone and inhaler.
Swelling; Pain; Large red area; This case was reported by a consumer and described the occurrence of swelling in a 66-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included paracetamol (Tylenol Extra Strength).   On 9th December 2022, the patient received Shingles vaccine. On 9th December 2022, less than a day after receiving Shingles vaccine, the patient experienced swelling. In December 2022, the patient experienced pain and erythema. On an unknown date, the outcome of the swelling was not recovered/not resolved and the outcome of the pain and erythema were unknown.   It was unknown if the reporter considered the swelling, pain and erythema to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16-DEC-2022 Reporter's Comment: The patient was self-reported this case. The patient reported that she received Shingles vaccine. The patient stated that after received Shingles vaccine she experienced swelling, pain and large red area. The patient stated that her doctor office was aware of situation and they know about her allergies and history of reactions. The patient did not receive the treatment for the swelling. The reporter did not consent to follow up. Additional supportive information: As per reported the concomitant product X S Tylenol conservatively coded Tylenol extra strength.
Pt left triage vm, said she received the Covid vaccine Thursday, on Sunday began having frequent stomach cramps that have not eased up. She is at work today, but is nauseas, still having frequent stomach cramps
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  PULMONARY EMBOLISM W INFARCTION, UNSPECIFIED
nausea; vomiting; diarrhea; rapid heart rate; severe dehydration; unable to eat or drink; Extremely fatigued all day; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 47 years old, administered in arm right on 28Apr2021 12:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included spinach allergy, UC (Ulcerative colitis). Concomitant medication included mesalamine. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 47 years old, administered in arm right on 07Apr2021 12:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. On 29Apr2021 01:00, less than 24 hours of second vaccine there was nausea, vomiting, diarrhea and a rapid heart rate and severe dehydration. This progressed and led to hospitalization from Saturday 01May2021 to 04May2021 and resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient also experienced unable to eat or drink and extremely fatigued in 2021. As of this message (10May2021), still unable to eat or drink without vomiting and hear rate up to 170+. This was up from a normal resting heart rate of near 60. Extremely fatigued all day, vomit several times per day and loose stool to diarrhea multiple times per day. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had been tested for COVID-19, covid-test (blood test) on 02May2021: negative. Treatment was received for all events. The outcome of the events was not recovered.  Information about batch/ Lot number has been requested.
Uncontrollable shivering, chills for more than an hour followed by being hot.  The whole episode last 2-3 hours.
This spontaneous report was received from a 26 year old female patient who was also a pharmacist, referring to herself. Concomitant therapies included propranolol and XANAX. Patient stated that she does not have any pertinent medical history or drug reactions or allergies. On 03-MAR-2018, the patient was vaccinated with first dose of GARDASIL 9 (strength, dose, frequency, route, lot number and expiry date not reported) for prophylaxis. On the same day, within 3 to 4 hours, the patient experienced headache. She stated that on a pain scale from 0-10, headache was about 5. The patient was treated with 400 mg of ibuprofen twice daily for headache. The outcome of headache was reported as not recovered. Causality assessment was not provided. No further information was provided. Product quality complaint was not present.
appointment vasovagal /menopausal event post-vaccination w/persistent low BP : dizziness
Urticaria within 30-60 minutes of vaccine, swollen lips and hives.
Fever; Chills; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M204) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Hypertension, Thyroid disorder, High cholesterol and Penicillin allergy. Concomitant products included AMLODIPINE for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information was reported.
Left arm red, swelling of  the face, large  site reaction  - lip edema w/o other symptoms.
no adverse event; All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border. Patients between 6m-5y of age. Were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border presentation.; All doses were given 0.2 ml dosage form instead of 0.25 ml; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border. Patients between 6m-5y of age. Were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border presentation.), UNDERDOSE (All doses were given 0.2 ml dosage form instead of 0.25 ml) and NO ADVERSE EVENT (no adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. In April 2023, the patient experienced WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border. Patients between 6m-5y of age. Were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border presentation.) and UNDERDOSE (All doses were given 0.2 ml dosage form instead of 0.25 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border. Patients between 6m-5y of age. Were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border presentation.), UNDERDOSE (All doses were given 0.2 ml dosage form instead of 0.25 ml) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border. Patients between 6m-5y of age. Were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border presentation.) and UNDERDOSE (All doses were given 0.2 ml dosage form instead of 0.25 ml).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter. This case contains information about patient 3rd out of 12 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-722123 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-722123:(patient 1)
This spontaneous report was received from a male pharmacist of unknown age concerning himself via a company representative. No pertinent medical history was reported. No drug reaction or allergies were reported. It was reported that, on an unspecified date while he was reconstituting ZOSTAVAX (dose, route and frequency was unknown), some of the vaccine squirted out onto his hand (unspecified hand) (accidental exposure to product) and on an unspecified date after this incident, he developed an unspecified rash in the same area on his hand where he came in contact with the vaccine. The pharmacist reported that the rash lasted for a duration of 2 weeks. No other concomitant therapy was reported. Outcome of the event rash was reported as recovered/resolved. Outcome of accidental exposure to product was unknown. The causality of the event rash was unknown. No product quality complaint (PQC) was involved. Additional information has been requested.
83 yo male, normally followed. Reportedly, he has had altered MS for the past few days. Developed acute dyspnea today so wife called medics. When they arrived, his sats were in the 60s, HR 30s and SBP 65. He was intubated in ER for hypoxia and unresponsiveness.   He is a chronic dialysis patient, with his last dialysis run yesterday, no problems reported with this. He has a chronic cough, perhaps worse in the past week. No fevers, no N/V.   PROGRESS NOTE 1/31/2022 Renal Follow-up Note Date of Service: 1/31/2022   Chief Complaint: ESRD Subjective:    He remains intubated and sedated.  He remains on low-dose pressors.  TFs ongoing.  He has been nodding yes/no and seems to deny any pain.  Assessment/Plan:              1.  ESRD.  HD Site:   Dialyzes MWF  Dialysis Prescription: L AVF; T=3hrs; 2K, +Heparin, EDW 86kg             - Plan on dialysis with pressor support today.   2.  COVID pneumonitis with sepsis.             -  Vent              -  Dexamethosone ongoing             -  Will continue to pull fluid on dialysis as tolerated.             -  Empric ABX pending micro   3.  Sepsis/ Hypotension.  Echo showed RV dysfunction and pulmonary hypertension.             -  Continues pressors                4.  Anemia.               -  Receives EPO 1K QHD as an outpatient.  Hgb presntly above goal in ESRD, so holding.   5.  HPTH of CKD.             -Have added PhosLo now that he is on TFs.
Left arm became acutely red and swollen from site and down to the fingers. Associated with malaise and fever up to 104. Pt took ibuprofen and symptoms decreased 50% by 24 hours and resolved by 72 hours.
This spontaneous case reported by a consumer, describes the occurrence of vaccination site pain (arm showed soreness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 026L20A) for COVID-19 immunization. The patient's past medical history included no adverse event. No medical history reported. On Dec 29, 2020, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Dec 29, 2020, patient experienced of vaccination site pain (arm showed soreness). At the time of the report, of vaccination site pain (arm showed soreness) resolved. Reporter did not allow further contact. No concomitant medications or treatment information reported. 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.
Redness, rash, swelling and soreness of (Rt) upper arm and shoulder (swelling), fever for a couple of days. Onset 12/17/11. Lasted a couple of days. Pt. called to report on 12/21/11. No treatment.
Started illness, fever, body aches 24 hours after vaccination. Seen in office and worsened and went to ER (10/12/23). She was hospitalized (10/14/23) and Dx with Guillan Barre during hospital stay. Labs done at hospital had sl elevation sgot, low plts and low wbc(higher than 2 days before). Put on naproxen and doxy to cover for anaplasmosis. Lyme and tick borne disease illnesses negative. Chemistries otherwise negative. Is hydrated. Treated with IGIV
Early this morning 0700 while cleaning an office building I felt sick to stomach high in my stomach, headache-heavy feeling, neck aches, chills, no fever.  Temp is my regular 97.7°. I did not go to work my full job, pharmacy tech
Joint pain worsen after getting the first dose and is lingering; This is a spontaneous report from a non-contactable other health professional (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm on an unspecified date (batch/lot number was not reported) as 1st dose, single for COVID-19 immunization. Medical history included allergic to antibiotics. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not  receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced joint pain worsen after getting the first dose and was lingering on an unspecified date with outcome of not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current available information and the consistency with the known safety profile of the suspect product BNT162B2, a possible contributory role of the suspect product BNT162B2 to the development of event  Arthralgia cannot be excluded.  The case will be reassessed if additional information becomes 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.
Exactly 3 days after receiving the 2nd dose, became EXTREMELY DIZZY and LIGHTHEADED.  I am STILL EXPERIENCE DIZZINESS when I lie down and get up.
Information has been received from a nurse concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown date the patients were vaccinated with doses of improperly stored ROTATEQ, lot # K014826, expiration date 28-MAY-2016 (dose not reported) orally. No adverse symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient was brought in by grandmother for covid vaccine. She had signed permission from the mother giving permission to vaccinate the child. When asked about age, the grandmother said she was 12. Unfortunately, she was given a vaccine. Later, when trying to put the information into database, it was discovered that the patient was one month too young to receive the vaccine. The mother was contacted and the patient had no side effects and no adverse reactions. We told her she could not have her second vaccine until she was really 12 years old.
sick; stomach ache; lethargic; stomach problems; fever after first dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), ABDOMINAL PAIN UPPER (stomach ache), LETHARGY (lethargic), GASTROINTESTINAL DISORDER (stomach problems) and PYREXIA (fever after first dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Eczema (eczema patches in the past but nothing terrible.).    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced ILLNESS (sick), ABDOMINAL PAIN UPPER (stomach ache), LETHARGY (lethargic), GASTROINTESTINAL DISORDER (stomach problems) and PYREXIA (fever after first dose). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. At the time of the report, ILLNESS (sick), ABDOMINAL PAIN UPPER (stomach ache), LETHARGY (lethargic), GASTROINTESTINAL DISORDER (stomach problems) and PYREXIA (fever after first dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications include Birth control pill.   This case was linked to MOD-2022-515565, MOD-2022-515567.
TOOK THREE DOSES BEFORE THE FOURTH DOSE WENT DOWN THE SINK; This spontaneous case report (PVX2019-2136) was received from a pharmacist on 20-Aug-2019. It described a female consumer who "took three doses before the fourth dose went down the sink" (PT: Product dose omission), while being on Vivotif for an unknown indication.  Case report: The consumer took the first three doses of Vivotif before the fourth dose went down the sink. She took the third dose on 11-Aug-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took three doses before the fourth dose went down the sink" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took three doses before the fourth dose went down the sink" was considered as not applicable
Pfizer 1/5/21, 1/26/21, 10/13/21. Positive on 1/18/22
Became very tired, took a 3 hour nap starting roughly at 6pm. Woke up around 9:30pm with flu like symptoms, lethargic and didn't feel like I was able to move, but was not comfortable laying in bed. Got chilly shortly after waking up around 9:30 pm. Was able to feel warm with a hoodie, sweatpants, thick socks, and a blanket on.  Was not hungry but felt like eating was not a good idea. I didn't feel like I had the energy to eat. I was drinking water as I felt it was necessary. I went back to bed around 11:30pm and woke up the next morning feeling fine. My arm was sore for 2 days, afterwards, ached near the injection site, and when I used the upper arm muscles to move my arm. I'm not sure after that because I was taking ibuprofen and Tylenol for cramps.
Dizziness, Arthralgia, Nausea Vomiting, fever, sore throat, stiff neck
HEADACHE; LIGHTHEADEDNESS; This spontaneous report received from a patient concerned a 35 year old female. 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: 1805022, expiry: 25-MAY-2021) dose was not reported, administered on 24-MAR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced lightheadedness. On 31-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and had not recovered from lightheadedness. This report was non-serious.
loss of appetite; cough,coughing mucus up; CONTINUED CHILLS; chills; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), DIARRHOEA (Diarrhea), DECREASED APPETITE (loss of appetite), COUGH (cough,coughing mucus up) and CHILLS (CONTINUED CHILLS) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced CHILLS (chills) and DIARRHOEA (Diarrhea). On 10-May-2021, the patient experienced DECREASED APPETITE (loss of appetite), COUGH (cough,coughing mucus up) and CHILLS (CONTINUED CHILLS). On 08-May-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, CHILLS (chills), DECREASED APPETITE (loss of appetite), COUGH (cough,coughing mucus up) and CHILLS (CONTINUED CHILLS) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment details were provided.
Several patients were administered PROQUAD during this temperature excursion; This spontaneous report was received from a register nurse referring to patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.   On an unspecified date in 2020, the patient was vaccinated with 0.5 ml of an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (rHA) (PROQUAD) lot # T021302, expiration date 19-DEC-2021 for prophylaxis  (frequency and route of administration were not reported) (product storage error).  The improperly stored suspect vaccine experienced one temperature excursion of - 5 Celsius degrees (°C) for 20 hours. The call was made due to a digital data logger. No previous temperature excursion was reported.
2 Days of vomiting 0and diarrhea with some melena. This was 1st, and only, dose of Rotateq.