chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feels unsteady on his feet; Feels weak on his feet/ downgrading of his health; Insomnia; He is now using a cane which he didn't use before; Weight loss; Very fatigued; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (Feels unsteady on his feet), ASTHENIA (Feels weak on his feet/ downgrading of his health), INSOMNIA (Insomnia), WALKING AID USER (He is now using a cane which he didn't use before) and WEIGHT DECREASED (Weight loss) in an elderly 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSSTASIA (Feels unsteady on his feet), ASTHENIA (Feels weak on his feet/ downgrading of his health), INSOMNIA (Insomnia), WALKING AID USER (He is now using a cane which he didn't use before), WEIGHT DECREASED (Weight loss) and FATIGUE (Very fatigued). At the time of the report, DYSSTASIA (Feels unsteady on his feet), ASTHENIA (Feels weak on his feet/ downgrading of his health), INSOMNIA (Insomnia), WALKING AID USER (He is now using a cane which he didn't use before), WEIGHT DECREASED (Weight loss) and FATIGUE (Very fatigued) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: decreased (Low) decreased.         The concomitant medications were not reported. The treatment information was not provided.
Approximately 5 cm area, left upper lateral arm, redness and swelling, pain, induration, warmth 2 days post vax (5th shot in series).
She wasn't able to stand; headache; her extremities couldn't work at all.; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (She wasn't able to stand), PAIN IN EXTREMITY (her extremities couldn't work at all.) and HEADACHE (headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided ).   On 04-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (her extremities couldn't work at all.). On 04-Feb-2021, the patient experienced DYSSTASIA (She wasn't able to stand) and HEADACHE (headache). On 11-Feb-2021, HEADACHE (headache) had resolved. At the time of the report, DYSSTASIA (She wasn't able to stand) and PAIN IN EXTREMITY (her extremities couldn't work at all.) outcome was unknown.            No concomitant medication reported   No treatment medication reported
No adverse events were reported.  Gave 2 year old client the adult dose of Novartis vaccine instead of child dose of Sanofi vaccine.  Reported to CDC and was told no additional side effects should be expected and dose still counts as a valid dose.
Petechia on forearms bilaterally, and easy bruising Called PCP who indicated could be related to vaccine
patient began to experience pressure behind both eyes. Diastolic BP noted to be elevated 120/104  P 97@ 1429. Repeated 1430 137/82 P 105, 1432 129/75 P 96 and 1449 124/74. O2 sats 100%. Symptoms subsided before dismissal home.
Pt cried inconsolably for 5 hours starting 45 minutes after vaccine administration. Parents give Tylenol prior to vaccine administration. not known if fever present, diarrhea present after shot also.
rapid heartbeat - 96 just to stand up and take a few steps. 148 heart beat to stroll 50 yards, when I normally exercise walk hard with a 100 heart rate. After 3 days of this went to cardiologist. See Item 19. Symptoms lasted for 8 days. Extremely low Blood Pressure
Received Pfizer vaccines on 5/22, 6/12/21 COVID-19 positive by PCR on  1/8/22 admit to hospital on 1/8-1/9 for DKA in setting of COVID
I contracted COVID from close exposure the evening of 12/20/21 over the course of about an hour indoors (sitting next to a COVID positive person during dinner) and had mild symptoms consisting of an itchy throat and dry cough by 12/25/21. I took multiple rapid at-home tests that came back negative until the morning of 12/27/21 when I finally tested positive. I experiences a fever of 100.3 for about a day, extreme fatigue, body aches, head aches, light sensitivity, foggy cognition, and extreme sinus congestion and runny nose. The cough and respiratory symptoms were mild in comparison to the sinus congestion, and only a mild loss of smell, likely due to the congestion occurred. I missed work for a full week (12/27 through 12/31) and was still recovering for another full week and testing positive for COVID with symptoms until the morning of 1/10 when I finally tested negative again on a rapid at-home test.
No other adverse events reported; an expired PROQUAD was administered to three different patients today; This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not provided.  On 10-MAR-2022, an expired measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD), 1 dose, was administered as prophylaxis (route of administration and anatomical location were not provided; lot number T030760 has been verified to be valid, expiration date 08-MAR-2022) to three different patients (expired product administered). It was confirmed that the vaccines were properly stored up through time of administration. No additional adverse events were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2203USA003958: US-009507513-2203USA003811:
Nurse reported a patient received a dose of PREVNAR 13 on 12/31/2018 and a dose of PNEUMOV AX 23 on 7/5/2019; Nurse reported a patient received a dose of PREVNAR 13 on 12/31/2018 and a dose of PNEUMOV AX 23 on 7/5/2019; This spontaneous report was received from a nurse referring to a 66-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not provided.  On 05-JUL-2019, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) for prophylaxis (concentration, frequency, vaccination scheme, route and anatomical location of vaccination were not reported). Lot Number R033080 has been verified to be a valid lot number for pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) expiration date reported and validated as 06-JUN-2020).  The nurse reported that before the vaccination with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23), the patient had been vaccinated with pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR), which occurred on 31-DEC-2018 (inappropriate schedule of product administration and interchange of vaccine products).   No additional information was provided.
2 nights after her vaccines, she had an "odd grunting, inconsolable" cry. Stopped and turned "ghost white" for a few minutes.
Dizziness, headache, vomiting, chills/body aches (in sequence) symptoms started within 1/2 hr of injection.
Patient experienced night sweats, arm pain, redness and swelling that is hot to the touch 3-4 inches below the injection site. Pt presented at Dr's office with these symptoms that had lasted 4 days on 08-11-2018 and was given Cephalexin 500mg 1 4 times daily x 7 days and a generic MEDROL dose pack for 6 days.
Patient complained of not being being able to catch his breath. Chest was feeling tight. No complaints of feeling dizzy. 10:35 am his vitals 02 sat were 99 Heart rate was 85 Blood Pressure 100/65 respiration 24 and patient stated he felt better. NO signs or symptoms of respiratory distress noted. Vital signs prior to release at 10:50 am were 02 sat 99%. Heart rate 82.  Blood pressure 108/66. Respiratory rate was 20. Patient stated he continued to feel fine. No respiratory distress noted. Released to leave at 10:53 with guardian/aunt.
CANCER; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the reported stated that a lot of people got Covid shot and got cancer and shit out of it.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cancer was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20230447238 and 20230446012.; Sender's Comments: V0: 20230445860-cancer. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Slightly pink, 4 inch long, 1.5 inch wide, oval of pink; Sore arm after the administration; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Sore arm after the administration) and VACCINATION SITE ERYTHEMA (Slightly pink, 4 inch long, 1.5 inch wide, oval of pink) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced AXILLARY PAIN (Sore arm after the administration). On 19-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Slightly pink, 4 inch long, 1.5 inch wide, oval of pink). On 08-Jan-2021, AXILLARY PAIN (Sore arm after the administration) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Slightly pink, 4 inch long, 1.5 inch wide, oval of pink) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2021: Follow-up added including Concomitant medication added- Statin On 08-Jun-2021: Follow up added and Contact information updated.
Muscle contractions/tightness right side of neck up thru jaw and ear; also made tinnitus much worse; muscle contractions/tightness right side of neck up thru jaw and ear; also made tinnitus much worse; Muscle cramping/soreness in right forearm within 1 minute of injection; lasted 4-5 days.; muscle cramping/soreness in right forearm within 1 minute of injection; lasted 4-5 days.; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the right arm on 28Jun2021 at 13:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to MSG (food allergy). The patient was allergic to iron pills sometimes. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 28June2021 at 13:00, the patient experienced muscle cramping and soreness in right forearm within 1 minute of injection and it was lasted for 4-5 days. On 28June2021 at 13:20, starting within 20 minutes of injection when she was driving home, the patient experienced muscle contractions/tightness on right side of neck up through jaw and ear; also made tinnitus much worse. It had been 3 weeks at the time of report and issues were still there and it also impacted her hearing which was not good. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  No therapeutic measures were taken as a result of reported the event(s).  The clinical outcome of the events muscle cramping and soreness in right forearm were recovered in Jul2021. The clinical outcome of the events muscle contractions and tightness right side of neck up thru jaw and ear, and tinnitus were not recovered, at the time of this report.
This spontaneous report as received from a patient's mother refers to a male patient of an unknown age. Information regarding the patient's pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On 08-APR-2016, the patient was vaccinated with GARDASIL (lot number, expiration date, dose and route of administration were not reported) or GARDASIL 9 (lot number, expiration date, dose and route of administration were not reported). It could not be confirmed whether the vaccine was received by the patient. On an unknown date in April 2016, the patient experienced two swollen lymph nodes after receiving the vaccine. There was no product quality complaint. The outcome of the event was not reported. The relatedness between the event and the vaccines was not reported. Additional information is not expected as the reporter declined to participate in answering questions within this adverse event report.
Pediarix instead of Dtap; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 17-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number E9Y29, expiry date 26-OCT-2024) for prophylaxis.   On 18-AUG-2023, the patient received Pediarix. On 18-AUG-2023, an unknown time after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: Pediarix instead of Dtap).  The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-AUG-2023 The reporter reported that, they were intending to administered Dtap and inadvertently administered Pediarix instead of Dtap, which led to wrong vaccine administered. The reporter did consent to follow up.
This spontaneous report was received from a registered nurse refers to a 4 year old patient. The patient's medical history and concurrent conditions were not reported. On 03-AUG-2015, the patient was vaccinated with an improperly stored VARIVAX (Merck) (lot # L010144, expiry date 24-MAR-2017). Concomitant medications were not reported. The outcome was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
After she received the flu shot, she had a toni-clonic seizure while in the waiting area. Pharmacist came to her aid and we called 911.  She was fine afterward. EMS evaluated and cleared her to go home. She did not go in ambulance. The grandmother told us that she had a similar reaction ("she passed out") at the doctor's office after receiving Gardasil. She mentioned this after-the-fact and did not state this in the consent form. Pharmacist updated her profile and documented this incident in case she request for flu shots in the future.
can't even think; no sense of smell; sick; headache; flu type symptoms with sinus pressure; flu type symptoms with sinus pressure; sore throat; brain fog; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program.  A 28-year-old female patient received BNT162b2 (lot number: EL3246), via an unspecified route of administration in left arm on 09Jan2021 at single dose for covid-19 immunization. There were no medical history and concomitant medications. The patient got the COVID 19 vaccine on 09Jan2021, and symptoms started shortly right after, with headache, flu type symptoms with sinus pressure, all on 09Jan2021; and this morning (13Jan2021) she woke up with no sense of smell. She is so sick right now (13Jan2021), said she can't even think right now (13Jan2021). The patient stated the only thing that improved was the headache went away, and in the first two days (Jan2021), she had a sore throat, and that has gone away, but everything else has stayed constant. The patient had brain fog in Jan2021. The patient underwent lab tests and procedures which included weight: 125 pound range. The outcome of the event headache was recovered on 09Jan2021, the sore throat was recovered in Jan2021, other events was not recovered.
(potentially related) intervening event in HCC reduction (unexpected benefit);   This literature marketed report has been received from the authors of a published literature article, titled as stated above and refers to a 65-year-old female patient. No information regarding her medical history or concomitant therapy was provided. The patient's concurrent conditions included alcohol-associated cirrhosis. On an unknown date in December 2018, she was diagnosed with infiltrative 17 cm hepatocellular carcinoma (HCC) with occlusive portal vein tumor thrombus and serum alpha-fetoprotein (AFP) of 40 250 ng/mL. On an unknown date, she was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (formulation, strength, dose, frequency, route of administration, lot#, expiry date were not reported) for prophylaxis. On an unspecified date in February 2019, she experienced spontaneous regression. On an unknown date in June 2019, (reported as: before treatment was initiated), she showed a spontaneous decrease in serum AFP to 250 ng/mL, prompting repeat magnetic resonance imaging (MRI). On an unspecified date in July 2019, the MRI surprisingly showed complete involution of both the primary tumor and the portal vein tumor thrombus. In October 2019, she reached a complete remission with no viable tumor. On an unspecified date in December 2019, she experienced the 1.5 cm HCC recurrence treated with transarterial chemoembolization (TACE) for a small area of suspected recurrence. In April 2020, the patient was asymptomatic with AFP  less than 2 ng/mL, in remission.   The authors of a published literature article considered unexpected therapeutic benefit to be possibly related to Pneumococcal Vaccine, Polyvalent (23-valent)(manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.
Rash started at site of injection within 24 hrs & spread to bilat upper ext's. Macula/papular/ erythematous. Most intense at inj. site w/bumpy, almost confluent, almost vesicular lust.
Severe pain in injection site immediately when vaccine was administered lasting for several minutes.  The same evening I woke up with foot and leg pain on my left side.  It felt like my leg / foot were on fire and lasted about 30 miutes.
redness and itchiness at the injection site; redness and itchiness at the injection site; the patient had a red, itchy hard spot where she got the injection; soreness; This is a spontaneous report received from a contactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (lot number unknown, expiration date: Jun2021), via an unspecified route of administration in left arm, on 02Apr2021 at single dose for COVID-19 immunization. The patient's medical history included pre-diabetic(Diagnosed about a year ago), hypothyroidism(Diagnosed in her 20's), high cholesterol(diagnosed with high cholesterol a long time ago, about the same time as when the hypothyroidism was diagnosed). Concomitant medications included metformin at 1000 mg twice a day for pre-diabetic (the patient has been taking Metformin for about a year or so), levothyroxine sodium(L-THYROXINE) at 50 mcg once daily for thyroid(the patient started taking L-thyroxine probably 40 years ago when she was in her 20's), rosuvastatin calcium(CRESTOR) at 20 mg once daily for high cholesterol (the patient began taking Crestor probably within the last 6 months), Allergy shots from the end of Nov2020 or beginning of Dec2020. The patient gets allergy shots every Friday.  The patient reported that her last allergy shot was on 22Mar2021.  The patient reported that she was told that she had to wait 5 days between getting an allergy shot and the Covid-19 vaccine, so she didn't get allergy shot on Friday, 02Apr2021.The patient was previously taking Atorvastatin for high cholesterol. The patient received 1st dose on 02Apr2021 and later that afternoon along with soreness, the patient had a red, itchy hard spot where she got the injection. The patient reported that her arm at the injection site has been red and itchy.  The patient reported that the injection site is still red and itchy today, 06Apr2021, and inquired if that is normal. The patient reported that the redness and itchiness at the injection site is not as bad as it was.  The patient reported that she has been putting ice on the injection site. No Emergency Room visit was required. The outcome of the event "soreness" was unknown and of the other events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Vomiting, fever of 100.3 ( at time of reporting ), body aches. Starting at 6:00 AM.
Over 100 lesions mostly on face, mouth and torso. Fever on 8/13 and 8/14. Afebrile today.
Small swelling under right arm; In arm pit with soreness; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 19Apr2021 at 11:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included ibuprofen 800 (MANUFACTURER UNKNOWN), OTC ibuprofen (MANUFACTURER UNKNOWN) and ademetionine (SAM-E); all started on unknown dates and for unspecified indications. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 29Mar2021 at 11:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 21Apr2021 at 07:00, the patient experienced small swelling under right arm, in arm pit with soreness. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events small swelling under right arm, in armpit with soreness were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.