chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At the end of our clinic, a staff member at the facility became dizzy and anxious. Client has hx of HTN and takes meds daily for control. Vital signs stable, no report of pain. 911 called, EKG assessed abnormal rhythm, Client taken to hospital for further evaluation. I stayed until client left the facility. Client was administered Moderna first booster-shot. She had no previous hx of this reaction with the first couple of primary vaccinations.
Periodic menstrual bleeding (showed up on underwear and when using the bathroom 1-2 times a day about every 2-3 days) until April 11. On April 11 I got my menstrual cycle 2 days early, but much more severe than usual. Including nasuea, severe cramps (could not stand), heavy flow, and sleeping all day. My normal symptoms are light cramping and light flow.
A 63 year old female reported that she had a reaction to the influenza virus vaccine (manuf unk) in approximately 1992 when she was 53 years old. Within 45-60 minutes of receiving the vaccine, she experienced chest tightness, wheezing, bronchospams, hives, itching, and some cramping and diarrhea. She described the reaction as "mild anaphylaxis." In later years, she received several smaller doses of the flu vaccine, but still reacted with the same symptoms. One year, she received 1/4 of a normal dose, along with prednisone, and did not experience a reaction. Another year, she received a skin test with the Parke-Davis flu vaccine, and she also reacted. She is normally treated with hydroxyzine HCl for the reaction. The pt noted that she was allergic to antibiotics and to sulfites. Anaphylaxis was considered medically important. No further info was available as of the date of this was reproted.
The pt woke up on 3/24/01 with a fever of 104. By that evening, the pt's parents noticed pox. She now has greater than 100 pox covering her body.
Vial was First punctured on 05-Oct-2022 9 am and it remain in fridge till 12-Oct-2022; No adverse event; Dose administered >12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture), PRODUCT STORAGE ERROR (Vial was First punctured on 05-Oct-2022 9 am and it remain in fridge till 12-Oct-2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Oct-2022 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was First punctured on 05-Oct-2022 9 am and it remain in fridge till 12-Oct-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture), PRODUCT STORAGE ERROR (Vial was First punctured on 05-Oct-2022 9 am and it remain in fridge till 12-Oct-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) and PRODUCT STORAGE ERROR (Vial was First punctured on 05-Oct-2022 9 am and it remain in fridge till 12-Oct-2022).    No concomitant drug were reported.  HCP wanted to know how to proceed with a pediatric patient (6 months to 5 years of age) that received a Monovalent vaccine greater than 12 hours post punctured. No side effects have been reported yet. HCP did not have any Medical History information from the patient. Vial size was reported as 2.5 mL.  On 20-Sep-2022, the vial was initially stored in the refrigerator. On 05-Oct-2022 9 am vial was first punctured.  Vial was stored in the fridge at correct temperature. Vial did not undergo any temperature excursions. It was reported that 5 doses were drawn 1 minute per dose.  No treatment drug were reported.
The patient has a history of CKD stage III and history of kidney transplant on immunosuppressive therapy. She was seen in the ED on 9/11/23 for nausea, body aches, and hot/cold flashes that started a few days prior. A COVID-19 PCR test was done which resulted positive. Ultimately, the patient was admitted 9/11/23 - 9/13/23 with acute hypoxemic respiratory failure secondary to COVID-19 pneumonia/pneumonitis, among other diagnoses. During admission she initially required 3 liters of supplemental O2, however by discharge she was able to wean to room air. Of note, the patient has received the primary COVID vaccine series and two boosters.
Patient presented with his grandmother for dose 2 of moderna primary series.  The incorrect registration form was provided to guardian for completion.  This registration form was labeled with Moderna bivalent booster, 12+, 0.5mL sticker, according  to age of indication.  A Moderna bivalent booster, 12+, 0.5mL vaccine and the coinciding vaccine card sticker was provided to the administrator.  Age and DOB were clearly labeled on the form. This provider called patient's mother and discussed error and answered questions as best as possible,  We will also be contacting the state on-call line for further instruction following submission of this report.
Developed large area of cellulitis- very red and hot and spreading but lower than shot site. Given RX for Keflex for 7 days 3x daily. Stopped spreading 2nd day and redness faded by 3rd day Still showing rashy area on 6th day but definitely fading
Patient presented to the emergency department via EMS on 5/27/2022 with altered mental status, tested Covid-19 positive via PCR that day, and subsequently diagnosed with pneumonia due to Covid-19 and was admitted. Patient continued to overall decline during admission and ultimately passed away on 6/4/2022. In medical chart, Covid-19 is not listed as a cause of death.
Joint pain; Muscle pain; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6201) via an unspecified route of administration on Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced joint pain on an unspecified date, muscle pain on an unspecified date. Consumer confirmed the lot number as EN6201, limited information is available over the call. The outcome of the events arthralgia, myalgia with outcome of not recovered.  No follow-up attempts are possible. No further information is expected.
Narrative:  Patient states that an hour and 15 mins after his first vaccine he developed urticaria on his chest and itching from head to foot that lasted 24 hours. In addition his smell and taste was off and he felt a lump in his throat for about 6 hours. After consultation with Nurse Practioner and counseling eith patient he elected not to get vacccine. He was offered the Jannson Vaccine in 2 weeks but declined. No evidence of hospitalization or treatment with medication to combat these symptoms.
Initial report received from a consumer (patient) on 17 JANUARY 2013. A 65-year-old female patient whose medical history and concomitant medications were not reported had received an intramuscular dose of FLUZONE (batch number, dose number, route and anatomical site of administration were not reported) on an unspecified date. On an unspecified date (at the night of vaccination) the patient had bad flu symptoms. Corrective treatment and relevant laboratory data were not reported. On an unspecified date, i.e. next day the patient had recovered from the event. Document held by sender: None.
Got all possible side effects except vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Got all possible side effects except vomiting) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No medical history information reported.  Concomitant products included LOSARTAN, MAGNESIUM OXIDE (MAG-OX), MELOXICAM, METOPROLOL, OMEPRAZOLE, SIMVASTATIN, SERTRALINE HYDROCHLORIDE (ZOLOFT), ATROPA BELLADONNA, CAFFEINE, CARBINOXAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE (NOVACO S) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION COMPLICATION (Got all possible side effects except vomiting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-Mar-2021, VACCINATION COMPLICATION (Got all possible side effects except vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Blurred vision; Rigors/Shivering; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from an unspecified date to an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced blurred vision and rigors/shivering, all on an unspecified date with outcome of unknown.    Information on the lot/batch number has been requested.
pt recv vax 15JUL96 & 15SEP96 pt devel a classic zoster rash, covering dermatome L2 & appearing on rt thigh & back;
Covid Arm Large, red,  warm, itchy rash  Swelling  Pain/sensitive injection site  Hard lump at injection site
Pt has intense itching, swelling, warmth, and tenderness at and around the injection site (left arm).
Aside from the usual chills arm pain aches and general malaise for 5 days  , I?ve had more frequent and looser stools and stomach cramping since the day of the vaccine .
Approx. 8 days following the 1st shot of Moderna, my arm began to itch at injection site. I developed a red, circular itchy rash (eventually as big as @4 inches in diameter).  Arm ached and was warm to touch in area of rash.  About the 3rd day, I started taking benadryl at night so I wouldn't scratch.  On the 5th night of the rash, though not as red, it became very itchy so I applied a generous amount of hyrdrocortisone in addition to taking benadryl.  By the next morning it had mostly cleared up.  I was not concerned about this because I looked it up and found that this was a harmless side effect that others had experienced.  Pictures I saw online were exactly like what I experienced.  No big deal.    FYI -- I have had itchiness and red welts (though not a rash) appear in a similar timeframe with prior tetanus shot and a few flu vaccines.
She stated she had a funny taste in her mouth and needed to have a bowel movement and then she passed out.
feeling like "a bad rash in mouth"; loss of taste because of chapped mouth; rash on back; rash on top of both arms; dry mouth; end (tip) of tongue burning; lips "molting like snakeskin"; inability to eat; "whole inside of mouth burning"; raw mouth; tongue "feeling sunburnt"; lips felt "sun burnt."; feeling of "rush/surge"; Chapped lips; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DRY MOUTH (dry mouth), ORAL MUCOSAL ERUPTION (feeling like "a bad rash in mouth"), TONGUE DISCOMFORT (end (tip) of tongue burning), LIP EXFOLIATION (lips "molting like snakeskin") and CHAPPED LIPS (Chapped lips) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy, Allergy to chemicals (Allergic to dyes and preservatives.) and Allergy to vaccine (lip swelling).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced CHAPPED LIPS (Chapped lips), PARAESTHESIA ORAL (tongue "feeling sunburnt"), ORAL DISCOMFORT (lips felt "sun burnt.") and FEELING ABNORMAL (feeling of "rush/surge"). On 27-Mar-2021, the patient experienced EATING DISORDER (inability to eat), ORAL DISCOMFORT ("whole inside of mouth burning") and STOMATITIS (raw mouth). On 19-Apr-2021, the patient experienced DRY MOUTH (dry mouth), TONGUE DISCOMFORT (end (tip) of tongue burning) and LIP EXFOLIATION (lips "molting like snakeskin"). On 27-Apr-2021, the patient experienced ORAL MUCOSAL ERUPTION (feeling like "a bad rash in mouth"), AGEUSIA (loss of taste because of chapped mouth), RASH (rash on back) and RASH (rash on top of both arms). At the time of the report, DRY MOUTH (dry mouth), ORAL MUCOSAL ERUPTION (feeling like "a bad rash in mouth"), TONGUE DISCOMFORT (end (tip) of tongue burning), LIP EXFOLIATION (lips "molting like snakeskin") and CHAPPED LIPS (Chapped lips) had not resolved, AGEUSIA (loss of taste because of chapped mouth), EATING DISORDER (inability to eat), ORAL DISCOMFORT ("whole inside of mouth burning"), RASH (rash on back) and RASH (rash on top of both arms) outcome was unknown, STOMATITIS (raw mouth), PARAESTHESIA ORAL (tongue "feeling sunburnt") and ORAL DISCOMFORT (lips felt "sun burnt.") was resolving and FEELING ABNORMAL (feeling of "rush/surge") had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment on visit to physician on 30-MAR-2021 includes Magic mouthwash to be used before meals, Vaseline (topical to lips), Chapstick (topical to lips), Beeswax (topical to lips).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: updated events( rash and ageusia ), the vaccine was withdrawn after the 1st dose.
body pain; joint pain; tiredness; sore at injection site; A spontaneous report was received from a consumer concerning a 73- Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events general body pain, joint pain, tiredness, sore injection site.  The patient's medical history included lung infection and blood pressure. No relevant concomitant medications were reported.  On 08-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch: 012L20A) in the right arm for prophylaxis of COVID-19 infection.  On the same day, the patient experienced the events achy all over, joint pain, tiredness, sore injection site.  No Laboratory details provided.  Treatment details included Tylenol/Advil probably.  Action taken with mRNA-1273 in response to the events was not reported.   On 10/JAN/2021 the outcome of the events general body pain, joint pain, tiredness, sore injection site was resolved.; Reporter'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.
sore arm 2 hours after injection low grade fever started around 8 PM 100.7+ Fever, body aches, chills, light headed by 9 PM
After 7 days following first shot some day time hullucinations and exhaustion  Day after 2 nd shot slept - -14 days after this shot exhibiting exhaustion and some  day time hulluciations, Exhibiting NARCOLEPSY behavior
Pulmonary embolism found by CT scan 9/12/22, after reporting breathing difficulty for several weeks (during any activity such as swimming laps) during checkup; sent to ER. Went to Hospital; kept overnight;two anti-clot injections (8/12 and 9/13), released evening 9/13/22 with Eliquis 5 mg am and pm.
weird reaction to pneumonia vaccine; This is a spontaneous report from a contactable consumer, reporting for herself. A 59-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), via an unspecified route of administration on an unspecified date at a single dose for immunization. Medical history included ongoing hypothyroidism. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient experienced weird reaction to pneumonia vaccine on an unspecified date six years ago. The clinical outcome of the event, weird reaction to pneumonia vaccine, was unknown.  Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Patient was  given 0.2ML of the 30MCG formula instead of 0.2ML of the 10MCG formula.
Information has been received from a certified medical assistant concerning a 4 year old female who on 9/10/01 was vaccinated with a dose of varicella virus vaccine live. On 10/24/04, the patient developed a mild case of shingles on her right upper chest. She saw a doctor, no medical treatment was ordered and there is no information on the patient's present status. There was no product quality complaint involved. Additional information has been requested.
A report has been received from a Health Professional concerning an adult, female patient, who had been receiving Nasal FLUMIST. FLUMIST started on 25-Dec-2012. The patient experienced tested positive for Influenza A which started on 25-Dec-2012. The patient recovered from the event of tested positive for Influenza A on an unspecified date. The report was considered to be non-serious.
shingles; neck pain; rash; I wasn't able to work for days; had pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Family history included shingles (mother had shingles.).   On an unknown date, the patient received Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced shingles (Verbatim: shingles), neck pain (Verbatim: neck pain), rash (Verbatim: rash), impaired work ability (Verbatim: I wasn't able to work for days) and pain (Verbatim: had pain). The outcome of the shingles, neck pain, rash and impaired work ability were resolved and the outcome of the pain was resolved (duration 5 months).   It was unknown if the reporter considered the shingles, neck pain, rash, impaired work ability and pain to be related to Shingrix.     It was unknown if the company considered the shingles, neck pain, rash, impaired work ability and pain to be related to Shingrix.   Additional Information: GSK Receipt date: 28-JUL-2023 This case was reported by patient via interactive digital media. The reporter reported that her mother had shingles, but she was not afraid of getting it because of her active, healthy lifestyle. The reporter states that she got the shingles shot and shortly after got the shingles. The reporter states that she knows, shingles varies from person to person but for her, it started with four days of neck pain. The pain kept getting worse. Then a rash developed, and her doctor diagnosed with shingles.  The pain was so intense that she not able to work for days. Even after the rash went away, she had pain that lasted for five months. She wishes she would not have waited to learn more about shingles.  The reporter states that don't wait talk to a doctor or pharmacist today about shingles prevention for those over 50. Follow up was not possible, as no contact details were available.
So 30 minutes after taking the vaccine I developed headache and nausea. Other symptoms that developed with the first 24 hours were arm pain, extreme fatigue and fever. I missed work for 3 days.  I still feel tired I don't know if it's from the vaccine. So the very next day I called my Occupational health services on 10/4 at my job and spoke with the nurse and they said the symptoms are to be expected. 2/6 I called a physician again. And then I spoke to the NP on 2/8 because I was having limited range of motion and arm pain. They told me to take Tylenol and Aleve, which I did.
Extreme fatigue; nausea; muscles aching; muscle twitching; sweating; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 11Mar2021 at 12:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included myasthenia gravis, undiagnosed autoimmune disorder, non-alcoholic fatty liver disease, hypertensive heart disease and allergy to mushrooms. Concomitant medications included unspecified medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. On 11Mar2021 at 12:45, the patient experienced extreme fatigue, nausea, muscles aching, muscle twitching and sweating. No treatment was given for the events. The outcome of the events extreme fatigue, nausea, muscles aching, muscle twitching, and sweating were not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Patient presented to clinic complaining of severe left shoulder pain, exacerbated with range of motion,  since date of administration. Patient provided confirmation of receipt from pharmacy, placed in patient  documents. Vaccine also present in Immunization Registry. Patient was advised to take  anti-inflammatories for pain relief and was referred to orthopedic surgery for further evaluation and  treatment.
24 hours post vaccine c/o soreness of the tongue, lower gums and throat still ongoing. C/o painful swallowing
slight fever; tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (slight fever) and FATIGUE (tired) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 014M21A and 003B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (slight fever) and FATIGUE (tired). At the time of the report, PYREXIA (slight fever) had resolved and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: After each shot patient had slight fever for a couple of hours.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment drug was not reported.