chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Grade 3 chills; body aches/pain; left underarm lymphnode swelling; This is a spontaneous report from a contactable other hcp (patient). A 50-years-old- non- pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: El9265, Expiration Date: unknown) via unspecified route administration in arm left on 08Feb2021 12:30 as a single dose for covid-19 immunisation. Medical history included allergies: PCN and first dose of covid vaccine received on 18Jan2021 at 12:00. Prior to the vaccination patient was not diagnosed with covid-19. Since the vaccination the patient had not been tested for Covid-19. The patient's concomitant medications were not reported. On 09Feb2021 at 02:00 the patient experienced Grade 3 chills, body aches, left underarm lymphnode swelling and pain. Patient had not been treatment for the adverse event. The outcome of the event was recovered.
Fever to 101, soreness at injection site with flu like symptoms that started 24hrs after injection.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 16-FEB-2017 at 08:32, the patient was vaccinated with improperly stored ZOSTAVAX injection (lot # M011665) (expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000237: US-009507513-1704USA000485: US-009507513-1704USA000486: US-009507513-1704USA000487: US-009507513-1704USA000488: US-009507513-1704USA000489: US-009507513-1704USA000490: US-009507513-1704USA000491: US-009507513-1704USA000492: US-009507513-1704USA000493: US-009507513-1704USA000494: US-009507513-1704USA000495: US-009507513-1704USA000496: US-009507513-1704USA000497: US-009507513-1704USA000498: US-009507513-1704USA000499: US-009507513-1704USA000500: US-009507513-1704USA000501: US-009507513-1704USA000502: US-009507513-1704USA000503: US-009507513-1704USA000504.
My menstrual cycle changed and was two weeks early. Since nothing else in my life has changed, the only reason for the menstrual change is a vaccine.
Rash beginning on 5/25/01 on body, spread to face; fever; coryza prior to rash. Seen in ER on 5/26/01 about 08:00. Titers drawn for Rubella. Doctor feels he felt post-auricular lymphadenopathy. Tylenol prescribed for fever.
Information has been received from a physician concerning a male pt who on 10/24/01 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. About 4 hours, post vax, on 10/24/01, the pt developed hives over the injection site, which was red. Unspecified medical attention was sought. The pt's wife also experienced an injection site reaction (WAES 01112924) after vaccination the same week with pneumococcal vaccine 23 polyvalent. Additional information has been requested.
Date and time adverse event started: 1st dose 3/17/2021 ADE started same day at approx 4-4:30pm. For the 2nd dose 4/13/2021 ADE started same day at approx 4-4:30pm.  Adverse events experienced and are they still occurring now:  1st dose 3/17/2021 ADE started same day at approx 4-4:30pm, pt experienced chills, body ache, and fever; symptoms lasted 3 days. For the 2nd dose 4/13/2021 ADE started same day at approx 4-4:30pm also, pt experienced body ache, weakness, dizzy, fatigue, and she had slight fever (fever got worse on 2nd day 3/14/20210). Pain at injection site on her left arm with sign of very small red dot appearance. Today 4/15/2021, in the afternoon pt feels less tired and achy, but still feel warm.  Pt stated she took Tylenol every q4hrs for her symptoms both times after rcvding her vaccines.  ***NOTE*** Recommend pt to continue to stay hydrated and to make sure to consume adequate meals to help with fatigue. Also counseled to take Tylenol with food to prevent upset stomach and to make sure not to exceed 4,000 mg per day, and to avoid consuming alcohol to avoid liver injury while taking Tylenol. Advised pt if symptoms worsen or does not get better to contact MD.
Patient contacted us on 09/07/2022 stating that covid-19 vacaccine  she received on 08/26/2022 is causing her to have  a heavy prolonged menstruation. We advised the patient to seek medical attention for the side effects she is experiencing.  We are unable to reach  patient at the listed phone we have on file  for information on items # 5 and 21.
VOMITTING/CANNOT KEEP ANYTHING DOWN, IT KEEPS COMING BACK UP; CHILLS; MALAISE; FEVER 102; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced vomiting /cannot keep anything down, it keeps coming back up. On 03-MAY-2021, the subject experienced chills. On 03-MAY-2021, the subject experienced malaise. On 03-MAY-2021, the subject experienced fever 102. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever 102, malaise, vomiting/cannot keep anything down, it keeps coming back up, and chills. This report was non-serious.
Really large tender spot on arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Really large tender spot on arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced INJECTION SITE PAIN (Really large tender spot on arm). At the time of the report, INJECTION SITE PAIN (Really large tender spot on arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported by reporter. No treatment medications were provided by reporter.   Reporter did not allow further contact
Local swelling (R/tricep area). Loss of range of motion to right arm. Heat to the area of immunization. Itching.
Patient reports being extremely tired for 6 days after vaccination.  Patient also states they have a measles-like rash on torso and arms that has been itching.
Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  The vial did not undergo any temperature excursions Total of 102 doses were given from LOT 026C21A  Treatment medication was not provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non significant follow up was received.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 02Jun2022 as dose 4 (booster), single (Lot number: FJ4989) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "Lung cancer" (unspecified if ongoing); "Known allergies: sulfa drugs" (unspecified if ongoing), notes: Known allergies: sulfa drugs; "Known allergies: iodine in contrast media" (unspecified if ongoing), notes: Known allergies: iodine in contrast media. Concomitant medication(s) included: ATORVASTATIN, start date: Jan2012, stop date: 08Aug2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient received COVID-19 Treatment as Paxlovid from 08Aug2022 to 12Aug2022. Patient also reported that he had a recurrence of COVID symptoms and resumption of positive home antigen test.
itchiness; rash; raised; pinkish; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchiness), VACCINATION SITE RASH (rash), VACCINATION SITE SWELLING (raised) and VACCINATION SITE ERYTHEMA (pinkish) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included Shingles (patient had her Shingle shot 4 or 5 years ago). Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) for Anticoagulant therapy, MULTIVITAMINS & MINERALS PLUS LUTEIN and COLECALCIFEROL (VITAMINS D3).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness), VACCINATION SITE RASH (rash), VACCINATION SITE SWELLING (raised) and VACCINATION SITE ERYTHEMA (pinkish). At the time of the report, VACCINATION SITE PRURITUS (itchiness), VACCINATION SITE RASH (rash), VACCINATION SITE SWELLING (raised) and VACCINATION SITE ERYTHEMA (pinkish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Treatment  include applied Hyrocortisone cream.
I had a mild, but painful shingles rash on my back on the left side for months. I also had double vision for two weeks. I was given medication for the rash, but I did not end up taking it. I went to my eye doctor as well and I was given a prescription for eyeglasses. But eventually the double vision went away, so I did not get the new prescription.
Mother stated child was dazed, eyes open and unresponsive however breathing. Left leg shaking which progressed to full leg shaking.
This spontaneous report was received from a Registered nurse regarding a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1804USA005153:
This spontaneous report was received from a pharmacist and refers to a patient of unknown age an gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown date in March 2016, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (dose, lot# and expiration date were not reported) for prophylaxis. On 04-MAR-2017, the patient was vaccinated with a second dose of ZOSTAVAX subcutaneously, lot # M035148, expiration date 25-OCT-2017 (dose was not reported) for prophylaxis.  No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
No additional adverse effects reported; experienced a temperature excursion.; A medical assistant states that "on an unspecified date last week" a patient was administered MMRII (unknown lot/expiration) with STERILE DILUENT (lot S026378 expiration 05/15/2022) that experienced a temperature excursion.; This spontaneous report was received from a medical assistant, referring to a patient of an unknown gender and age.  The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On approximately an unknown day in May 2020 (also reported as "on an unspecified date las week") the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route of administration, vaccination scheme, anatomical site of vaccination,  lot number and expiration date were not reported) as prophylaxis, it was reconstituted with sterile diluent (MERCK STERILE DILUENT) (strength, dose, frequency, and route of administration were not reported; and lot # S026378 , which has been verified to be valid, expiration date reported and validated as 15-MAY-2020) that experience a temperature excursion (product storage error and product preparation issue), as record by a data logger, it was reported that measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was stored at proper storage range. Information about temperature excursion and time frame was not specified. No additional adverse effects were reported.
Fever,body aches,chills,heada he body aches,light sensitivity,,sore throatpain at site
Expired Dose of Heplisav-B was Given; Initial Report Received on 13-Aug-2021  A pharmacist reported that a 26 year-old female (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported. The patient was not pregnant.  No relevant concomitant medications were reported.    On 12-Jul-2021, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, and NDC # not reported).  On 13-Aug-2021, the patient received the second dose of HEPLISAV-B (Lot # 933622, expiration date 01-Aug-2021, serial number 597626603178 and NDC # 43528-003-05) in the left deltoid. No adverse effects were reported.  No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Persistent Fever & Chills starting 1/26/22, treated with alternating Ibuprofen and Tylenol Petechiae rash in bilateral lower extremities and edema and pain  making walking difficult. Severe fatigue, malaise Treated with high dose steroid and tapered off, and Naproxen
This report has been received from the nurse reported that VARIVAX (Merck) (lot # H020587, expiration date 13-NOV-2014) and PROQUAD (MARRS# 1311USA012185) were through unsupported temperature excursions on 26-JUN-2013, 01-JUL-2013 thru 31-JUL-2013 and the entire month of August 2013. On 15-AUg-2013 the patient was administered the unsupported VARIVAX (Merck) (dose and route not reported). This is one of several reports received from the same sourse (MARRS# 1311USA002616, 1312USA003306, 1312USA003308, 1312USA003309, 1312USA003310, 1312USA003311, 1312USA003312, 1312USA003313, 1312USA003314, 1312USA003315, 1312USA003316, 1312USA003317). Additional information is not expected.
Upper arm, back, neck and above shoulder started aching; Whole torso was aching.; Back, neck and above shoulder started aching; Neck and above shoulder started aching; Shoulder started aching; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Upper arm, back, neck and above shoulder started aching), PAIN (Whole torso was aching.), BACK PAIN (Back, neck and above shoulder started aching), NECK PAIN (Neck and above shoulder started aching) and ARTHRALGIA (Shoulder started aching) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M02A) for COVID-19 vaccination.     The patient's past medical history included Surgery (Implantation for Vagus Nerve Stimulation therapy). Concurrent medical conditions included Epilepsy (Patient states that she has not had an episode in two years.).    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Upper arm, back, neck and above shoulder started aching), PAIN (Whole torso was aching.), BACK PAIN (Back, neck and above shoulder started aching), NECK PAIN (Neck and above shoulder started aching) and ARTHRALGIA (Shoulder started aching). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of UNK dosage form. On 01-Mar-2021, PAIN IN EXTREMITY (Upper arm, back, neck and above shoulder started aching), PAIN (Whole torso was aching.), BACK PAIN (Back, neck and above shoulder started aching), NECK PAIN (Neck and above shoulder started aching) and ARTHRALGIA (Shoulder started aching) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-080144 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow up received. No significant information added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080144:2nd Dose
extreme fatigue, dizziness (so much that i couldn't walk), sick to stomach, sensitivity to sound and light, swollen lymph nodes (stilll have these), blurry vision, achy muscles
Petechiae Lower Extremities; Delayed reaction, COVID ARM 15CM; Itching on the head, arm and chest; Migraine attack X 1 (Took medicine before it became a full blown attack); Pain at the Injection Site; Swelling; Fatigue; Nauseous; This spontaneous case was reported by a physician and describes the occurrence of MIGRAINE (Migraine attack X 1 (Took medicine before it became a full blown attack)), PETECHIAE (Petechiae Lower Extremities), DIZZINESS (Itching on the head, arm and chest), VACCINATION SITE REACTION (Delayed reaction, COVID ARM 15CM) and VACCINATION SITE PAIN (Pain at the Injection Site) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Migraine (No reported medical history).    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at the Injection Site), VACCINATION SITE SWELLING (Swelling), FATIGUE (Fatigue) and NAUSEA (Nauseous). On 13-Mar-2021, the patient experienced MIGRAINE (Migraine attack X 1 (Took medicine before it became a full blown attack)). On 20-Mar-2021, the patient experienced DIZZINESS (Itching on the head, arm and chest). On 21-Mar-2021, the patient experienced VACCINATION SITE REACTION (Delayed reaction, COVID ARM 15CM). On 22-Mar-2021, the patient experienced PETECHIAE (Petechiae Lower Extremities). On 13-Mar-2021, MIGRAINE (Migraine attack X 1 (Took medicine before it became a full blown attack)) had resolved. On 15-Mar-2021, VACCINATION SITE PAIN (Pain at the Injection Site), VACCINATION SITE SWELLING (Swelling) and NAUSEA (Nauseous) had resolved. On 25-Mar-2021, DIZZINESS (Itching on the head, arm and chest) and VACCINATION SITE REACTION (Delayed reaction, COVID ARM 15CM) had resolved. At the time of the report, PETECHIAE (Petechiae Lower Extremities) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided No Treatment information provided
Swelling behind left ear, lymph node, pain to move head. taking two tylenol every 12 hours.
Heart palpitations, arrhythmias event during sleep  Dizziness from fluttering feeling
Information has been received from the Merck Pregnancy Registry for GARDASIL vaccine (yeast) via a health professional concerning a 17 year old female with a history of irregular periods (April 2005) and anorexia (March 2006) who on 19-NOV-2007 was vaccinated with a first dose of GARDASIL vaccine (yeast). Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI-CYCLEN). In January 2008, the patient was seen by the physician for metrorrhagia that was resolved. On 23-JAN-2008 the patient was vaccinated IM with a second 0.5 ml dose of GARDASIL vaccine (yeast) and then discovered she was pregnant. Estimated date of last menstrual period was 22-JAN-2008. Gestation at the time of the report was "5 months along." Estimated date of delivery is 28-OCT-2008. At the time of the report the pregnancy outcome was unknown. Additional information has been requested.
ON 1-7-21 IN THE EVENING, PATIENT STATES SHE STARTED WITH A DULL ACHE IN HER LEFT THIGH THAT COMES AND GOES. SWOLLEN NYMPH NODES. MILD TINGLING IN FOOT.
The night the patient got the vaccine, patient started getting soreness in the left arm. the next day, the pain was better, but now there is a swelling in the left arm with an area about the size of an egg.
Developed a rash, arm became swollen, firm, tender and warm to touch X 2 days, post vax.
Fever increased 101.2 w/ generalized rash. Fever noticed after going home from work. Rash on abd after working out on 10/14/15, then noticed on arms/legs (BLE and BUE).