chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chronic cough; soreness of left arm; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Chronic cough) and PAIN IN EXTREMITY (soreness of left arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-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 COUGH (Chronic cough) and PAIN IN EXTREMITY (soreness of left arm). At the time of the report, COUGH (Chronic cough) and PAIN IN EXTREMITY (soreness of left arm) outcome was unknown. Not Provided          The patient had chronic cough ever since a day or two after second dose.  The patient had used unspecified medication for treatment of cough.   Action taken with mRNA-1273 in response to the events was not applicable.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL (lot number not reported). The physician reported that the patient had "a file full of problems that she had incurred as a result of taking the vaccine". The physician did not provide what the specific problems were.
arm is very sore and sensitive off and on; 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 PAIN IN EXTREMITY (arm is very sore and sensitive off and on) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm is very sore and sensitive off and on). At the time of the report, PAIN IN EXTREMITY (arm is very sore and sensitive off and on) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were taken. No treatment drugs were taken.   Reporter did not allow further contact
Child's face became flushed on Mon. evening. Body stiffened out. Seemed unresponsive to Mom approx 10 minutes.
This is a spontaneous report from a contactable consumer (patient).  A 56-year-old male patient received PREVNAR 13 via an unspecified route of administration (at right arm, but not sure) in Oct2018 at single dose for prevention of pneumonia. Chest x-ray was all clear on the same day that he got the vaccine. Medical history included blood pressure high, borderline diabetes, cholesterol, pneumonia twice (first time was 15 years ago and second time he got pneumonia again back in Sep2018 and was told that he needed to get another pneumonia vaccine but that he should wait until the pneumonia cleared up). The patient got a pneumonia vaccine in Sep2016. Family medical history relevant to AEs was reported as none. Concomitant medication included metoprolol, atorvastatin, metformin, losartan. The patient he had a high fever in Oct2018, the fever began a couple of days after getting the vaccine. He went to the ER a couple days later because of the high fever and was admitted. He wasn't sure what he was admitted for exactly, just stated that there were 3 different doctors trying to figure out what was going on with him. He didn't remember the dates of his hospitalization. He thought he went in on a Tuesday and was released on a Thursday morning, and that this all occurred in Oct2018. The doctor thought he had cancer. His lymph nodes were enlarged so he had surgery to remove some of his lymph nodes to test them. They also drilled a hole in his bone to do a bone marrow biopsy. He was going to a Cancer Center where they were drawing his blood once a week, but in Nov2018 everything went back to normal. His lymph nodes went back to normal and there wasn't anything that resulted from the ones that were tested. There wasn't anything abnormal in his bone marrow. While he was in the hospital the doctor said that there was something messed up with his white blood cells, but those went back to normal too. After he got out of the hospital, he had to go to another doctor because his potassium was low. This other doctor took him off of the Metformin and Losartan in Nov2018 or late Oct2018 because his potassium was low. Onset of event potassium was low was 2018, rest of events occurred in Oct2018. The outcome of event potassium was low was unknown, outcome of rest events was recovered in Nov2018, duration was reported as 31 days. The patient stated that he was calling because his doctor didn't think that the pneumococcal 13-val conj vac (dipht crm197 protein) vaccine caused all this. He had been trying to find out if he still needs to get another vaccination, or do it over.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 24-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: EL1284), on 09Jan2021 as dose 2, single (Lot number: EL1284) and on 19Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 23 years for covid-19 immunisation. The patient's relevant medical history included: "Unspecified connective tissue disease" (unspecified if ongoing); "hypermobile ehler danlos" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing); "Penicillins" (unspecified if ongoing), notes: Known allergies: Penicillins. Concomitant medication(s) included: EMGALITY [GALCANEZUMAB]; FISH OIL; MELOXICAM; PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]; VITAMIN D [ERGOCALCIFEROL]. Past drug history included: Omnicef/cefdinir, reaction(s): "Known allergies: Omnicef/Cefdinir"; Augmentin, reaction(s): "Known allergies: augmentin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Antibody test: (unspecified date) Low, notes: history of low antibody titers; SARS-CoV-2 test: (2022) Positive, notes: Testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: Patient received Other medication in 2 weeks.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the event s drug ineffective,Covid-19 and the suspect drug BNT162B2 cannot be excluded
After 3 days after receiving a meningitis vaccine, patient is experiencing itchiness all over the body. Patient also has redness on groin area. Patient used vasoline to relieve symptoms. Patient is still experiencing these symptoms.
Diagnosed with non lactation mastitis; Lump and red area on right breast; Lump and red area on right breast; One day after second dose hard, hot red lump that hurt where injected; One day after second dose hard, hot red lump that hurt where injected; One day after second dose hard, hot red lump that hurt where injected; Mouth sores; Ear infection; Swollen glands; Sore throat; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 2021 (Batch/Lot Number: Ew0198); at the age of 42-years-old, as dose 2, single for COVID-19 immunization. The patient had no medical history. The patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in the left arm on 11Jun2021 6:00 PM, at the age of 42-years-old, as dose 1, single for COVID-19 immunization. Concomitant medication included fluoxetine hydrochloride (PROZAC); esomeprazole (ESOMEPRAZOLE); ciclosporin (RESTASIS); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Jul2021 07:30AM, the patient experienced lump and red area on right breast. Diagnosed with non-lactation mastitis. One day after second dose, hard, hot red lump that hurt where injected. 3 weeks after 2nd shot mouth sores, ear infection, swollen glands and sore throat. The patient received antibiotics and pending ultrasound and mammogram. The patient was not diagnosed or tested for COVID-19. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
103 (R) temp; pale; lethargic,lifeless; lasted around 24 hrs; gradual improvement, tylenol & sponge bathing used.
10 mins after first dose - Flushed, heart racing and head pressure. BP 139/89 - HR 115 Took Benedryl 25 mg P.O. Denied ER visit Released home.
experiencing itching at my injection site as if it were a mosquito bite that wont subside; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (experiencing itching at my injection site as if it were a mosquito bite that wont subside) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (experiencing itching at my injection site as if it were a mosquito bite that wont subside). At the time of the report, VACCINATION SITE PRURITUS (experiencing itching at my injection site as if it were a mosquito bite that wont subside) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications was reported.  Treatment information was not provided.
pt recvd vax; 8 days later exp sz & was hosp; tx w/ anti convulsants including dilantin; sxs resolved w/in 24 hrs;
ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY HYPOXIA
The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 08-Aug-2022.; No adverse event; Patient administered dose after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered dose after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 08-Aug-2022.) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination. No Medical History information was reported. On 08-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 08-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered dose after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 08-Aug-2022.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered dose after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 08-Aug-2022.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered dose after 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 08-Aug-2022.). No concomitant medications were reported. The health care professional (HCP) stated they administered dose of Moderna COVID-19 Vaccine after 30-day use by date. The vial did not undergo any temperature excursions. The HCP was not aware of any symptoms for patient after the vaccine was given. No treatment medications were reported.
Patient came to the pharmacy today  04/14/21 to report adverse effects she experienced post COVID vaccine. She states that she have been having headache since April 5th after her vaccine. She has been using acetaminophen 1000mg at lease twice a day.  She also complain of painful arm at the site of injection with no swollen site. No other symptoms mentioned. she mention an increase in INR from her last coumadin clinic but she did not mention to the clinic that had a vaccination.   Patient was advised to contact her primary care physician .
No additional AE; temperature excursion; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 09-MAR-2021, the patient was vaccinated with doses of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S039319, expiration date: 04-DEC-2021, 0.5 milliliter (formulation, strength and route of administration were not reported) and varicella virus vaccine live (oka/merck)(VARIVAX) lot # T022315, expiration date: 30-JUN-2022, 0.5 milliliter (formulation, strength and route of administration were not reported), both for prophylaxis.  On an unknown date, the doses of the vaccines were exposed to temperature excursion at -1.6 Celsius degrees (C) for 1 hour and 36 minutes. There was no previous temperature reported. The call was due to digital data logger. No additional adverse event was reported.
Informed by wife that a couple days after they were vaccinated patient came down with shingles and was seen by Dr for a mild outbreak.
Intense itchy rash appeared on both shoulders near the injection sites. Pt did not experience any reaction after the first dose, however, after the second dose both arms developed a red itchy rash.
This spontaneous case reported by a consumer, describes the occurrence of blisters (underneath the skin in hands, arms and legs) and tenderness (blisters tender to the touch and like she burnt herself) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 036A21A) for COVID-19 immunization. No medical history reported. Concomitant products included anastrozole for an unknown indication. On Mar 12, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced blisters (underneath the skin in hands, arms and legs) and tenderness (blisters tender to the touch and like she burnt herself). The patient treated with prednisone ongoing since an unknown date, at an unspecified dose and frequency. At the time of the report, blisters (underneath the skin in hands, arms and legs) and tenderness (blisters tender to the touch and like she burnt herself) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The patient uses an inhaler. Action taken with mRNA-1273 in response to the event: unknown.
Pt felt burning upon injection, and within a few minutes felt flushing and nausea.  Pt stated she had a headache at 10 minutes and felt numbness in her left hand at 15minutes.  Patient was escorted to Urgent Care in building for safety reasons.  After about 10 minutes she left the Urgent Care.
Patient confirmed 2nd dose of Pfizer received on 5/22/21. 3rd dose of Pfizer 0.3ml was administered to LA on 1/26/22 at 11:35AM. Patient denies allergies to medications, vaccines or foods. Patient reported that she tested positive for COVID-19 4 weeks ago, tested negative yesterday and feels well. Patient was asked to wait 15 minutes for observation. 10 minutes into observation, it was noticed patient trying to clear her throat and complained of feeling hot.  Patient was asked if she was Ok, Patient at that time reports that she is feeling hot,  having nausea and having difficulty swallowing.  Patient said she has allergies to shrimp and is encouraged to wait 30 mins for observation. V ital Signs  BP 130/80, HR 58  RR20, O2sat 98%. Patient sweating and vomiting, cold compress applied and patient continued to be monitored. Patient continues to have difficulty clearing her throat , vomiting and sweating, at that point 911 was called  02sat at 97%.  Patient continued to be monitored by staff until EMT arrived  and transferred to hospital. Patient was accompanied by daughter.
On 08/24/2001 the patient had small raised papules on the leg and arm around the injection sites. Believe this may be from alcohol wipes, not the immunizations.
Fatigue, then once going to bed, Extreme chills. Shivering. Fever reaching 103 Degrees Fahrenheit. Insomnia. Pain in the back, moreso than injection site pain. Pain in the abdomen. Pain in the neck. Intense headache.  Intense chills lasted from 11 oclock PM to 5am, then fever dropped to 100 degrees. Headache lasted until 4:00pm the next day. Fever dropped around 5:00pm the next day (1.27). Back pain and headache subsided around 11:00pm the next day, and by day two all symptoms were completley gone, including the insomnia.
Severe muscle soreness, weakness, exhaustion, erratic temp. 96.0 - 99.4, headache, dizzy.
Information has been received from a nurse concerning a female patient who was vaccinated with a dose of Gardasil.  Concomitant therapy included "multiple vaccinations" given on the same day.  Five minutes after receiving the vaccine, the patient experienced syncope.  Unspecified medical attention was sought.  Subsequently, the patient recovered quickly.  No product quality complaint was involved.  Additional information has been requested.
On 10/16/14 right deltoid and surrounding area became swollen, red, hot and itchy. She said she took ADVIL every 8 hrs, used ice packs for 15 mins on/off.
The pt experienced a 3 1/2 x 4 1/2cm induration and wheal.
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On 07-DEC-2011, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration unknown), as recommended for routine adult health maintenance and for the prevention of shingles. It was reported that the vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 12-NOV-2012, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles.  The patient was prescribed acyclovir for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
After receiving the booster (3rd shot) of the Pfizer COVID19 vaccine, I had a 64 day cycle between menstrual periods.  Then my regular period resumed on February 4th, only to be followed by another one 15 days later on February 19th.  I have heard this is happening so thought I should add my experience to the charts.  No treatment is needed and I suspect I am also pre-menopausal.  I am charting my cycle so will have further dates if cycles continue to be erratic.
24NOV91 pt recvd dose of Engerix-B & 24 hrs p/the inject pt devel a rash generlized on trunk; no tx was reported;
ACUTE RESPIRATORY FAILURE 1/2/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE  ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/3/2021 ACUTE HYPOXEMIC RESPIRATORY FAILURE  SHOCK, UNSPECIFIED 12/3/2021 ACUTE HYPOXEMIC RESPIRATORY FAILURE  ACUTE RESPIRATORY FAILURE 1/2/2022 OBSTRUCTIVE SLEEP APNEA  ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/3/2021 OBSTRUCTIVE SLEEP APNEA  SHOCK, UNSPECIFIED 12/3/2021 OBSTRUCTIVE SLEEP APNEA
Itchy rash at injection site. Swollen, painful lymph nodes in arm pit of arm that received injection for four days
Hoarse voice; Mucus from out of the chest; Fatigue; 100.4 F; Cough; Tickle in the back of the throat; Sore arm; "runny nose"; Systemic body pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Hoarse voice), THROAT IRRITATION (Tickle in the back of the throat), PRODUCTIVE COUGH (Mucus from out of the chest), PAIN IN EXTREMITY (Sore arm) and RHINORRHOEA ("runny nose") in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), RHINORRHOEA ("runny nose") and MYALGIA (Systemic body pain). On 13-Jan-2021, the patient experienced THROAT IRRITATION (Tickle in the back of the throat) and COUGH (Cough). On 14-Jan-2021, the patient experienced DYSPHONIA (Hoarse voice), PRODUCTIVE COUGH (Mucus from out of the chest), FATIGUE (Fatigue) and PYREXIA (100.4 F). At the time of the report, DYSPHONIA (Hoarse voice), THROAT IRRITATION (Tickle in the back of the throat), PRODUCTIVE COUGH (Mucus from out of the chest), PAIN IN EXTREMITY (Sore arm), RHINORRHOEA ("runny nose"), COUGH (Cough), MYALGIA (Systemic body pain), FATIGUE (Fatigue) and PYREXIA (100.4 F) had not resolved.        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.   Concomitant medication were not reported by the reporter. Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jan-2021: New events updated
pt recvd vax 26APR93 & devel arthralgia in both shoulders, particularly the lt; exp sharp pain around the socket of the lt shoulder radiating down to the mid-upper arm & anteriorly & posteriorly around the deltoid; sx lasted 2 wks;
Constant ache, on shot site - every day sometimes can't lift arm - at least 2x a wk - sometimes I get a really bad cramp and can't lift arm. Use a small vibrator till cramp stops take ibuprofen for ache.