chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chronic coughing, sore throat, SOB, chest tightness, congestion, losing my voice. This all started at 5:00 AM on 9/30/2021. I still have a sore throat, chronic cough,  some SOB, and losing my voice, so now my voice is deep because of that. I saw a doctor and she gave me tessalon for the cough, and albuterol inhaler. She does not think it is Covid-19.
Information has been received from a nurse concerning a patient who on unknown date was vaccinated with GARDASIL (LOT # was not provided) and passed out. The outcome of the patient was unknown. It was also unknown that the patient sought medical attention. Additional information has been requested.
Case number PHEH2012US018709, is an initial spontaneous report received from a physician on 05 Sep 2012. This report refers to an adult male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: unknown). The patient received only the lyophilized A powder component mixed with sterile water instead of CYW-135 liquid. No adverse event was reported.
Got weak; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Got weak) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Degenerative joint disease, Sulfonamide allergy, Tremor muscle (Leg tremor) and Primary progressive multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS), BACLOFEN and TAMSULOSIN for an unknown indication.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ASTHENIA (Got weak). At the time of the report, ASTHENIA (Got weak) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
warm, hot; itchy; real red looking; Extended rash on arm, real red looking; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warm, hot), PRURITUS (itchy), ERYTHEMA (real red looking) and RASH (Extended rash on arm, real red looking) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included METHOTREXATE for Polymyalgia rheumatica.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced INJECTION SITE WARMTH (warm, hot), PRURITUS (itchy), ERYTHEMA (real red looking) and RASH (Extended rash on arm, real red looking). At the time of the report, INJECTION SITE WARMTH (warm, hot), PRURITUS (itchy), ERYTHEMA (real red looking) and RASH (Extended rash on arm, real red looking) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Tested positive in October 2020.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patients rheumatologist told her to suspend the medication after the vaccine administration for a week  Other concomitant medication included Cholesterol medicine  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: TCR was received patient stated significant information that she feels fine now no additional information was received and outcome changed from unknown to recovered.; 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.
On 3/11 in eve., pt. noted onset "stiffness" right knee joint; next a.m. (3/12) awoke & noted stiffness w/swelling @ left knees (R > L) & "stiffness" in medial aspect of feet B/L without swelling. mild -> med. discomfort on ambulation, on 3/12, took ibuprofen 600 mg Q 8-12 hours without improvement - 3/13 a.m. sx tg -> left knee swelling ? right & right instep/ankle area now w/mild swelling & increased pain with ambulation. Continuing ibuprofen 600 mg Q 6-8 hours / leg elevation.  Negative fever / chills / rash / warmth / erythema.  Positive 2-3 cm b/l med. bursal effusions @ knees, negative tender on palp.  3/18/09 MR received from reporter. Pt contacted MD 3/12/09 with c/o bilateral knee pain and swelling, stiffness and bilateral ankle pain which cause discomfort when walking. PE (+) for bilateral knee effusions/swelling R>L. Tx: Advil and leg elevation. F/U TC 3/13/09 with increasing knee and ankle swelling. Referred for medical eval however pt did not go as sx had started to improve.  Only mild stiffness in L ankle remains.
The evening of shot: feeling out of it, light-headed, soreness at the injections site The morning after shot: intense fatigue, physical weakness, difficulty standing for extended periods; diarrhea
Pediatric dose was given to adult patient, no  adverse reaction and no signs or symptoms noted.
High Fever 102.5 from 4-24-4/27/11. Rash all over body small bumps on 4/27/11.
light flu symptoms after first dose; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (light flu symptoms after first dose) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder. Concomitant products included CORTICOSTEROIDS for Autoimmune disorder NOS.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (light flu symptoms after first dose). At the time of the report, INFLUENZA LIKE ILLNESS (light flu symptoms after first dose) 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 treatment medications were reported for first dose events.   This case was linked to MOD-2021-342720 (Patient Link).
itch 2 days ago which was only once in a while but was more like a faint itch; the area from the injection site turned into a pink color which was rather large (at least 3-4inches and 2inches wide) like a rash.; injection site turned really red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site turned really red), VACCINATION SITE PRURITUS (itch 2 days ago which was only once in a while but was more like a faint itch) and VACCINATION SITE RASH (the area from the injection site turned into a pink color which was rather large (at least 3-4inches and 2inches wide) like a rash.) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 027L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDRALAZINE for Blood pressure, SIMVASTATIN for Cholesterol, HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for Pain, AMITRIPTYLINE and BROMAZEPAM for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site turned really red). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itch 2 days ago which was only once in a while but was more like a faint itch) and VACCINATION SITE RASH (the area from the injection site turned into a pink color which was rather large (at least 3-4inches and 2inches wide) like a rash.). At the time of the report, VACCINATION SITE ERYTHEMA (injection site turned really red), VACCINATION SITE PRURITUS (itch 2 days ago which was only once in a while but was more like a faint itch) and VACCINATION SITE RASH (the area from the injection site turned into a pink color which was rather large (at least 3-4inches and 2inches wide) like a rash.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported
Pt received dose #2 Moderna COVID vaccine 2/2/21 @ Vaccine Clinic. Initially had some arm soreness, headaches, and malaise. 2/3/21 starting having chest tightness worse with deep breaths and exertion. Has also had low-grade fevers. Has some coughing with deep inspiration. Some mild nasal congestion and chronic throat pain/irritation. Taking Tylenol 1000 mg two hours PTA. 2/4/21 @ 1849 presented to Urgent Care for workup. Mild bilateral anterior cervical lymphadenopathy. Per provider "Symptoms are likely adverse effects from the COVID vaccine." Discharged home without escalation of care. Entered for tracking.
Blistering on injection site, nausea with dry heaves, 101 degree Fahrenheit temperature, swelling in groin area, swelling of arm vaccinated (left), chest ache, lower abdomen pain.
Pt received Ixiaro, Rabies, and Typhoid on 6/03/2010.  The first night pt experienced facial diaphoresis and flushing while body was cold from the neck down. Pt did not take temp but felt feverish, had a HA, all symptoms relieved with Aleve. HAs continued for 5 days, always resolved with Aleve. Pt also reports stomach cramping that has continued until 6/10/2010 though with less frequency, no diarrhea or vomiting. Pt states he is in excellent health and has never had these symptoms before. Pt reports no local inflammation or soreness at sites of injection.  SEs reported to physician asst and medical director.  Both think this relates to the Ixiaro, recommend giving it alone at 28 days.  Pt given rabies #2 6/10/2010, reported no SEs on 6/11/2010.
DIZZINESS; NO APPETITE; WEIGHT LOSS; STOMACH PAIN; FEELING OFF; EXTREME NAUSEA; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 01-APR-2021 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 01-APR-2021, the subject experienced dizziness. On 01-APR-2021, the subject experienced no appetite. On 01-APR-2021, the subject experienced weight loss. On 01-APR-2021, the subject experienced stomach pain. On 01-APR-2021, the subject experienced feeling off. On 01-APR-2021, the subject experienced extreme nausea. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from dizziness, extreme nausea, no appetite, weight loss, stomach pain, and feeling off. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as the case assessed as non-serious.
Reaction to DTaP, left leg warm to touch and swollen 4x3" induration and pain. Put on abx for cellulitis.
Headache, Myalgia, NauseaVomiting, FACIAL FLUSHING, PAIN AT INJECTION SITE, FATIGUE Narrative:  Other Relevant History:
body aches; a little headache; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient's mother) reported for a 22-year-old female patient that who received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 22-years, via an unspecified route of administration at single dose for COVID-19 immunisation. Medical history included in 2020, she got COVID last year, was positive last year in this time but the date was confused, had the blood test that was negative but her PCR was positive, so they said that she never got COVID and then in Sep2020 she had the antibodies and her daughter said "she got COVID one time", consumer was so confused because the testing wasn't clear. Concomitant medications were not reported. The patient historically received first single dose of BNT162B2 for COVID-19 immunization. During call consumer mentioned that her daughter got the second vaccine and everything was good with her. She could feel side effects but she was good. Consumer said that the only side effects were body aches and a little headache. That is it. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Employee received vaccine at work on 10/28/02. Employee came to work 10/30/02 with complaint of edema and pain rt arm a few hours after pnuemococcal vaccine. On inspection sig. edema with sl increase pinkness noted from just below elbow rt arm up to neck/shoulder area. Saw PMD 10/30/02 and put on Medro-dose pack. On 11/1/02 spoke with employee and observed sig decrease in edema in the arm in general but elbow remains edematous but is improving. 11/4/02 spoke with employee and asymptomatic except mild tenderness.
Headache, Myalgia, Arthralgia, Fever, Chills and bilateral calf tenderness. Narrative:  Continues to have bilateral calf tenderness, all other symptoms resolved within 24 hours.
two vials that experienced a temperature excursion where use to administer doses to patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (two vials that experienced a temperature excursion where use to administer doses to patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (two vials that experienced a temperature excursion where use to administer doses to patients). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (two vials that experienced a temperature excursion where use to administer doses to patients) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter. Treatment information was not provided   Reporter did not allow further contact
2 mo vaccinations on 12/13/10 -> PEDIARIX/HIB/PREVNAR/ROTARIX started with bloody stools about 1 week later; intermittent bloody stools since.
generally feeling unwell with weakness, body aches, headache since 2nd vaccine on 6/9/21 dizziness started 7/1/21. presented to ED on 7/2/21 and found to have low Hgb, elevated liver enzymes
DTaP given to R deltoid; area red, swollen, & hard to touch (hot); given MOTRIN, KEFLEX, and BENADRYL by PCM.  Area had a prior scratch to skin from furniture per father.
Right lower leg D.V.T. Shot given 2/27/08 approx 10:30 am. On 2/28/08 pt noticed ache in (R) lower leg. Worsened daily and to ER 3/21/08- Doppler confirmed RLE DVT Deep right posterior tibial vein. 3/27/08-records received for DOS 3/2-3/3/08- DC DX: Acute right lower extremity deep venous thrombosis. Admitted with C/O right lower extremity pain and swelling that started 4 days ago with swelling in right calf and some local pain which has increased. C/O shortness of breath.  Follow-up: Pt also found to have Factor V Leiden Heterozygous (1 copy of gene).
EXTREME FATIGUE AND MUSCLE FATIGUE PARTICULARLY IN LEGS,  DIFFICULTY CLIMBING STAIRS, SOB WHEN CLIMBING STAIRS.  CANNOT WALK LONG DISTANCES (1 MILE) CAN NO LONGER EXERCISE DUE TO EXTREME FATIGUE
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On 01-AUG-2016, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot # M000996, expiry date 07-JAN-2018, dose, strength, vaccination site, route unspecified). The vaccine was exposed to a temperature of 6.5 Fahrenheit (F) for 80 hours. Digital data logger was not involved. There was no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
PATIENT HAD A PAIN FROM LEFT SHOULDER DOWN TO LEFT LEG.  SHE HAD HEADACHE, FELT LIKE FLU SYMPTOM WITHOUT  FEVER,  AND HAD NO ENERGY.
Covid positive; Covid positive; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 24 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The patient reported Covid breakthroughs case, the patient was Covid positive with fever, chills, and aches.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101807392 same reporter/patient/product, different dose/event.
Patient started to cough after vaccine, felt it was her asthma. EMT on site took vitals 14:08 - BP 190/120, HR 118, R 20, labored and wheezing. Patient denies allergies but has long standing asthma and hasn't taken her medication today. RN advised patient to take Albuterol - patient took 3 puffs with immediate relief.  Vitals at 14:20 - BP 202/120, O2 97, HR 102. Ambulance called at 14:25 d/t increased BP and visible anxiety sx from patient, crying and coughing. 14:31 Ambulance assessed patient found BP lowered to 162/92, HR 108. Patient refused transport, will follow up with PMD or 911 prn worsening. Patient walked out of vaccination waiting area on her own and obtained a ride with Lyft.
This spontaneous case, initially received from other health professional (nurse) on 06-Nov-2018, concerns a 6-year-old, male child patient. On 30-Oct-2018, the patient was administered expired FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195216, and expiry date: 30-Apr-2018]. The patient didn't experience any adverse reactions after administration of the expired dose. The reporter assessed the case as non-serious. Non-significant follow-up received from the nurse on 21-Nov-2018: The nurse confirmed that, the patient didn't experience any adverse reactions after administration of the expired dose.
Myalgia, Arthralgia, Chills, Fatigue, swollen glands Narrative:
This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (rebound symptoms and positive antigen recurred) in a 57-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Concurrent medical conditions included Diabetes and Drug allergy. Concomitant products included METFORMIN for an unknown indication. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (rebound symptoms and pos. antigen recurred). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 15-May-2022 to 19-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (rebound symptoms and pos. antigen recurred) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: positive (Positive) positive antigen recurred 11 day. On an unknown date, SARS-CoV-2 test: positive (Positive) positive antigen. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. It was reported that medication helped immediately but symptoms and positive antigen recurred on 11 days. Device Date was reported as 26-May-2022. Company Comment: This is a spontaneous case concerning a 57-year-old, female patient with Concurrent medical conditions of Diabetes, who experienced the unexpected non-serious AESI event of Covid-19. The event occurred on an unknown date after the unspecified dose of mRNA-1273 COVID 19 Vaccine. Patient tested positive twice for SARS-CoV-2 test. Patient was treated with nirmatrelvir, ritonavir from 15-May-2022 to 19-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. It was reported that medication helped immediately but symptoms and positive antigen recurred on 11 days. The event outcome was reported as unknown. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The concurrent medical condition of Diabetes remains a confounder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report. Sender's Comments: Company Comment: This is a spontaneous case concerning a 57-year-old, female patient with Concurrent medical conditions of Diabetes, who experienced the unexpected non-serious AESI event of Covid-19. The event occurred on n unknown date after the unspecified dose of mRNA-1273 COVID-19 Vaccine. Patient tested positive twice for SARS-CoV-2 test. Patient was treated with nirmatrelvir, ritonavir from 15-May-2022 to 19-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. It was reported that medication helped immediately but symptoms and positive antigen recurred on 11 days. The event outcome was reported as unknown. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The concurrent medical condition of Diabetes remains a confounder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Information has been received from a case in litigation concerning a 60 year old female patient who on 26-Sep-20 was vaccinated with the third dose of RECOMBIVAX HB. On 07-Oct-2000, 11 days after the vaccination, the patient presented with diminished vision in the lower field of her right eye. A magnetic resonance imaging study result was normal. The patient was diagnosed with optic neuritis. On 11-Apr-2001, the MRI results showed mild nonspecific bilateral white mater disease. The patient was diagnosed with multiple sclerosis. The reporter felt that optic neuritis and multiple sclerosis were related to therapy with RECOMBIVAX HB stating that "there is a biologically plausible medical theory here in that patient's white cells interpreted the hepatitis B surface antigen as having some similarity to brain tissue and proceeded to attack the tissue. There is a logical sequence of cause and effect in that petitioner's receipt of her first two vaccinations primed her immune system, and the third vaccination in effect pushed her over the immunologic edge. And there is an appropriate medical interval between vaccination and injury. The physician testified that without the hepatitis B vaccinations, the patient would not have had optic neuritis and MS. Upon internal review, multiple sclerosis was considered to be an other important medical event. Additional information has been requested.
Patient has had multiple issues since her vaccination, afterwards started with flank pain, appendicitis with then removal of appendix, gastrointestinal issues.  I would need to fax in all of the information to support this documentation as there is unfortunately too much to list.