chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hospitalized for uncontrollable vomiting, diarrhea and weakness; Hospitalized for uncontrollable vomiting, diarrhea and weakness; Hospitalized for uncontrollable vomiting, diarrhea and weakness; This is a spontaneous report from a contactable consumer (patient). An 18-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in right arm on an unspecified date (Batch/Lot Number: EW0138) as 2ND DOSE, SINGLE for covid-19 immunisation. Patient not diagnosed with COVID-19 Prior to vaccination. Concomitant medication(s) included Bupropion; Sertraline; methylphenidate hydrochloride (CONCERTA). The patient had allergies on Prazosin and amoxicillin. Patient not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was hospitalized for uncontrollable vomiting, diarrhea and weakness on 27May2021 16:00. Patient received 2 liters of IV and potassium treatment. Event outcome was recovering. Emergency Room and Physician Office Visited. Covid Nasal Swab tested Negative on 01Jun2021.  Follow up attempts are needed. Further information is expected.
getting covid19; cold life symptoms; diarrhea; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (getting covid19), NASOPHARYNGITIS (cold life symptoms), DIARRHOEA (diarrhea), PYREXIA (fever) and CHILLS (chills) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN and LOVASTATIN for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced COVID-19 (getting covid19), NASOPHARYNGITIS (cold life symptoms), DIARRHOEA (diarrhea), PYREXIA (fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, COVID-19 (getting covid19), NASOPHARYNGITIS (cold life symptoms), DIARRHOEA (diarrhea), PYREXIA (fever) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, COVID-19: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
ran temp all that wk-exp chest pain, palpitation, dizziness, lumps in lower arm & pain & a tired deadness in lt arm;pain radiated where it was painful to touch lower fore arm;
Patient became tired, light headed, and faintish after 5 minutes. Had patient lay on floor with feet raised above their head.  EMT was called to evaluate.
very fast heartbeat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Celiac disease" (unspecified if ongoing); "gluten allergy" (unspecified if ongoing); "Psoriasis" (unspecified if ongoing), notes: diagnosed so around 35 or so; "psoriatic arthritis" (unspecified if ongoing); "strokes" (unspecified if ongoing); "high cholesterol" (ongoing). Concomitant medication(s) included: BABY ASPIRIN (ongoing); CRESTOR taken for blood cholesterol increased (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "She had taken 4 of the 5 Pfizer Covid Vaccines but each time she takes it she gets a very fast heartbeat and lasts for quite a while, sometime months"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "She had taken 4 of the 5 Pfizer Covid Vaccines but each time she takes it she gets a very fast heartbeat and lasts for quite a while, sometime months"; Flu vaccine (Dose number unknown, single), for Influenza immunisation. The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "very fast heartbeat". The event "very fast heartbeat" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient was asking if Paxlovid and Pfizer Covid Vaccine Comirnaty 2023-2024 formula had gluten and wants to know if the facility they had made in was gluten-free. She had taken 4 of the 5 Pfizer Covid Vaccines but each time she takes she got very fast heartbeat and lasts for quite a while, sometime months. she had a history of strokes and high cholesterol and psoriatic arthritis. Psoriatic arthritis was diagnosed a couple years after psoriasis diagnoses so around 35 or so. Still taking. Patient called her heart doctor and doctor said if got to 150-160 she would go in. The patient was worried about taking another Covid vaccine because of that reaction and so she wanted to know if the Pfizer vaccine had gluten. Caller stated she took the 1st and 2nd, she did not know year, that was when they came out. Took the 3rd and did not think she did the 4th apparently that was not working for whatever reason.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300352135 Same patient/vaccine/event, different dose.;
Blood in Urine; Acute Kidney Injury; Blurry vision; Fever; Fatigue; Nausea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administration date 27Apr2021 (Lot number: Ew0171) at the age of 40 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. Vaccination history included: BNT162B2 (Dose 1; Lot number: Ew01s1), administration date: 06Apr2021, when the patient was 40 years old, for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The following information was reported: BLOOD URINE PRESENT (hospitalization, disability, life threatening) with onset 27Apr2021, outcome "not recovered", described as "Blood in Urine"; ACUTE KIDNEY INJURY (hospitalization, disability, life threatening) with onset 27Apr2021, outcome "not recovered", described as "Acute Kidney Injury"; VISION BLURRED (hospitalization, disability, life threatening) with onset 27Apr2021, outcome "not recovered", described as "Blurry vision"; PYREXIA (hospitalization, disability, life threatening) with onset 27Apr2021, outcome "not recovered", described as "Fever"; FATIGUE (hospitalization, disability, life threatening) with onset 27Apr2021, outcome "not recovered", described as "Fatigue"; NAUSEA (hospitalization, disability, life threatening) with onset 27Apr2021, outcome "not recovered", described as "Nausea". The events "blood in urine", "acute kidney injury", "blurry vision", "fever", "fatigue" and "nausea" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: unknown results; urine analysis: blood in urine. Therapeutic measures were taken as a result of blood urine present, acute kidney injury, vision blurred, pyrexia, fatigue, nausea.  No follow-up attempts are possible. No further information is expected.
High risk of HPV 18 or 16; This spontaneous report was received from a nurse via a company representative referring to her daughter a 27 year old female patient. No information regarding the patient's concurrent conditions, medical history, drug allergies/reactions and concomitant medications were provided.   On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) via intramuscular route to prevent human papilloma viral (HPV), dose reported as 1 time dose (anatomical site of vaccination, lot number and expiration date were not provided).  In 2018 (reported as 3 years ago), the patient was diagnosed with high risk HPV 16 or 18 (papilloma viral infection).   At the reporting time, the outcome of papilloma viral infection was unknown.        The reporter did not assess the causal relationship between the event and the suspect vaccines.
Developed fairly severe tinnitus a few months after the booster.  I have no idea if the vaccine had anything to do with it, but the VSafe check-in said to report any change in health status.  In this case, the symptoms appeared several months after the Moderna bivalent booster (shot #5).
Headache; Nausea; Extreme Fatigue; Loss of Appetite; Redness/Soreness at Injection Site  Lasted about 24 hours. Slept almost the entire day except to go to bathroom and eat a small amount of food.
pt recvd vax JUL94 & exp an inj site rxn, nausea & myalgias w/in 24hrs p/vax;inj site rxn was a 6" x 6" area of erythema, heat & pain-lasted approx 1mo;nausea & myalgia lasted several days;MD visit;rx:Toradol-resolved
Light sensitivity to eye; sensitivity to noise / hearing has decreased; Fever; Chills; awful headache that has not gone; nausea; vomiting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PHOTOPHOBIA (Light sensitivity to eye) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PHOTOPHOBIA (Light sensitivity to eye), HYPOACUSIS (sensitivity to noise / hearing has decreased), PYREXIA (Fever), CHILLS (Chills), HEADACHE (awful headache that has not gone), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, PHOTOPHOBIA (Light sensitivity to eye), HYPOACUSIS (sensitivity to noise / hearing has decreased), PYREXIA (Fever), CHILLS (Chills), HEADACHE (awful headache that has not gone), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood potassium: low (Low) Potassium low.. On an unknown date, Carbon dioxide: down (Low) C02 levels down..         Patient cannot keep food down and she went to the emergency room twice, her Co2 levels were down, and her potassium was low. The patient was still experiencing these symptoms. Concomitant Treatment medication were not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, 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 events, a causal relationship cannot be excluded.
Erythema on right arm extending from deltoid to the anterior axillary line and down the medial aspect of the arm to the distal arm. Didn't reach elbow. Rocephin, Keflex.
Patient reports "not feeling right" for two weeks after vaccines. Reports redness at site for a few days and substantial pain for several weeks.
Allergic reaction; She just looks all daze out; This is a spontaneous report from a contactable consumer reporting for her daughter. A female patient of an unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on an unknown date as a single dose for COVID-19 IMMUNIZATION. Relevant medical history was not provided. Concomitant medication included she was on several medications (unspecified medications).  On an unknown date, the patient experienced an allergic reaction and she just looks all daze out. The outcome of the events allergic reaction and she just looks all daze out was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Systemic: Chills-Severe, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Severe, Additional Details: na
Spoke with patient, influenza shot administered > 2 weeks prior, severe pain 8/10 in shoulder, radiating to the arm and neck. Unable to use the arm effectively, no benefit with current pain management. Will speak to Potential risk for bursitis vs capsulitis. Recommended ortho referral, pt wants to defer until prednisone effect appreciated. Current Plans Started PredniSONE 20MG, 1 (one) Tablet 1 tab po qd for 5 days, #5, 5 days starting 09/21/2016.
Seen in office 3/7/08 at 1430 for mild erythema of approx 3x3 cm area on left deltoid. Dr stated redness and swelling already subsiding. Ice and Motrin recommended.
Cellulitis; Itchy at the injection site; Redness at the injection site; Puffy at the injection site; Warmth at the injection site; Fatigue; Low grade fever; This case was reported by a consumer via call center representative and described the occurrence of injection site cellulitis in a 72-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) for prophylaxis.   On 9th October 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular). On 10th October 2019, 1 days after receiving FluLaval Tetra 2019-2020 season, the patient experienced injection site cellulitis, injection site itching, injection site erythema, injection site swelling, injection site warmth, fatigue and fever. The patient was treated with cefalexin (Cephalexin). On an unknown date, the outcome of the injection site cellulitis, injection site itching, injection site erythema, injection site swelling, injection site warmth, fatigue and fever were unknown.   It was unknown if the reporter considered the injection site cellulitis, injection site itching, injection site erythema, injection site swelling, injection site warmth, fatigue and fever to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The patient received FluLaval Tetra 2019-2020 season in right deltoid. On Thursday, the patient started to develop cellulitis which included redness, puffy, warmth with itching at the injection site and also had fatigue along with low grade fever. He was in bed on Thursday, Friday and Saturday. On Sunday, he started to feel better. He saw the physician on 14th October 2019, and was started on due to cellulitis of the injection site. The reporter consented to follow up.
This initial spontaneous case, received on 05-Oct-2017, was reported by a pharmacist and concerns 26-year-old female patient. Patient's medical history and concomitant medications were not reported. On 04-Oct-2017, the patient received FLUAD (TIV) (dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 179002 expiry date: May-2018). On 04-Oct-2017, 26-year-old female received FLUAD vaccine (explicitly coded as inappropriate age at vaccine administration) instead of the FLUCELVAX. It was reported that, the patient had no adverse events since vaccine administration. The reporter assessed this case non-serious. Follow-up received on 16-Oct-2017: The vaccine administration details (route of administration: intramuscular, anatomical location: deltoid) were updated. It was reported that the patient had no adverse events since vaccine administration. Narrative amended accordingly. Significant case correction received 05-Oct-2017: The event "wrong vaccine administered" was deleted. The narrative was amended accordingly.
right away hand turn red and fingers became swollen and numb, she stated something started to happen to her lungs and she started to cough up flem, the next day she came sick that morning fever, chills and headache, a week later she started to have shortness of breath and sore throat and after that she developed the blood clots, got a lump behind in knee.
passed out 4 times; Withering away and is dying/wont live long enough; lost 20 pounds; He is still experiencing dizziness and too weak to get out of bed; Weak; Nausea; dry heaving 3-4 times/day; Swollen arm; Stopped eating; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-May-2021 and was forwarded to Moderna on 19-May-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out 4 times) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), FOOD REFUSAL (Stopped eating), RETCHING (dry heaving 3-4 times/day) and NAUSEA (Nausea). On 23-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out 4 times) (seriousness criteria hospitalization and medically significant), DIZZINESS (He is still experiencing dizziness and too weak to get out of bed) and ASTHENIA (Weak). On an unknown date, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (Withering away and is dying/wont live long enough) and WEIGHT DECREASED (lost 20 pounds). The patient was hospitalized until 23-Apr-2021 due to LOSS OF CONSCIOUSNESS. At the time of the report, LOSS OF CONSCIOUSNESS (passed out 4 times), GENERAL PHYSICAL HEALTH DETERIORATION (Withering away and is dying/wont live long enough), WEIGHT DECREASED (lost 20 pounds), PERIPHERAL SWELLING (Swollen arm), FOOD REFUSAL (Stopped eating), DIZZINESS (He is still experiencing dizziness and too weak to get out of bed), RETCHING (dry heaving 3-4 times/day), ASTHENIA (Weak) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment with Reglan and magnesium oxide pertained to the events experienced.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
pt recvd vax 22OCT92 & had mild cough & runny nose & low grade fever which resolved; devel red non palp macular rash; 27OCT92 exam otherwise nl
10 minutes post vaccine pt felt nauseous. Drank water and was encouraged to relax and sit in propped up position
March11,12,13 injection site pain /March14 -21 tiredness,severe headache,muscle pain chills, joint pain, fever,nausea, feeling unwell
Information has been received from a registered nurse concerning a 15 month old male with no known medical history or allergies who on 13-Feb-2006 was vaccinated SC with a 0.5mL dose of varicella virus vaccine live (lot #652557/1024R). There was no concomitant medication. On 01-Mar-2006 the patient was seen in the office for an abscess that developed at the injection site. It was noted that (KEFLEX) was ordered. On 07-Mar-2006 the abscess had improved but it was not completely resolved, it was 1/12 th of its original size. No laboratory diagnostic tests were performed. There was no product quality complaint involved. Abscess at the injection site was considered to be another important medical event (OMIC). Additional information has been requested.
Pain at site; Redness; Swelling; Vaccine was administered low in the muscle/ given midway between the shoulder and the elbow; Flu like symptoms; Warmth; Fever; Headache; Chills; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th September 2019, the patient received the 1st dose of Shingrix. On 28th September 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling and vaccine administered at inappropriate site. On an unknown date, the patient experienced influenza-like symptoms, feeling of warmth, fever, headache and chills. On an unknown date, the outcome of the influenza-like symptoms, feeling of warmth, fever, headache and chills were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site erythema and injection site swelling were recovering/resolving and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the influenza-like symptoms, injection site pain, injection site erythema, injection site swelling, feeling of warmth, fever, headache and chills to be related to Shingrix.   Additional case details were provided as follows: The patient stated, she got Shingrix on the last Saturday (of the reporting date). On that day, she experienced pain, redness, and swelling at the site.  The patient noted the elevation had come down and the 4 inch patch of redness was pink at the time of reporting, so it had improved.  The patient also had fever, chills, headache and flu like symptoms that lasted about 24 hours.  The patient was concerned that, her symptoms might be more pronounced because she felt the vaccine was administered low in the muscle and stated the shot was given midway between the shoulder and the elbow, which led to vaccine administered at inappropriate site.  About these adverse event, healthcare professionals were not asked, as they were not aware.
Started symptoms on 6/08/2021, cough, sore throat, nasal congestion, and headache.
I stayed in the parking lot for 15 minutes with no reaction. I drove to get gasoline, but within five minutes, my face became flushed, a little puffy, and very hot. I put cold compresses on it for about 10 minutes.  When it was less red, I left to return to home. I had no fever. I had only a sore arm and extremely tired for 36 hours. No breathing difficulties -- during the flush or afterwards.
Patient received a TDaP injection on 6/19/2017 (423pm) on the (L) deltoid patient states she went home 25 minutes later she ended up having seizure and was taken to the ER for evaluation.
Started with Muscle aches and fever like chill but no fever through the night. Following day I was Nauseous and very dizzy throughout the day but has mostly subsided except for stomach ache on day two.
USUAL SIDE EFFECTS; This spontaneous report received from a patient concerned a female of unspecified age. 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, and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced usual side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of usual side effects was not reported. This report was non-serious.