chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness; Night sweats; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Soreness) and NIGHT SWEATS (Night sweats) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A.) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and MIRTAZAPINE (REMERON) for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 23-Feb-2021, the patient experienced MYALGIA (Soreness) and NIGHT SWEATS (Night sweats). At the time of the report, MYALGIA (Soreness) and NIGHT SWEATS (Night sweats) outcome was unknown. Not Provided          Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Non significant follow up received on 17-MAY-2021, no new information
01/02/22 presents to ED for "Abdominal pain". PMHx of "Ulcerative colitis s/p total proctocolectomy and subsequently undergoing j-pouch excision/APR with end ileostomy"
Information has been received from a registered nurse concerning a currently 1 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with VARIVAX (lot #: M033906 with expiration date: 28-JUL-2018) (dosage schedule, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccine was improperly stored at temperature greater than 15°F but less than 46 °F  (15.5 °F) for 30 minutes and at temperature greater than 6 °F but less than 14 °F (10.1 °F) for 1.5 hours without any previous temperature excursion; this information was registered in a digital data logger. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA001065: US-009507513-1704USA001066: US-009507513-1704USA001068: US-009507513-1704USA001069: US-009507513-1704USA001070: US-009507513-1704USA001064: US-009507513-1704USA001067.
Rash, itchiness, redness, and bumps on waist, hands, head, ears, chin, ankles, chest, upper arms, back, legs.  Started 24 hours ago, 12 days after booster shot. On-going. Tanking otc allergy meds. Some reduction in itchiness, but not 100%
Patient received immunization on 10/15/18 and passed away the next morning on 10/16/18. He had multiple other comorbidities, but death was sudden.
unexpected benefit alleviation of chronic all over body pain, especially in the hands; swollen glands; fatigue; chills; fever; This case was reported by a consumer and described the occurrence of swollen glands in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included genital herpes (25 year history) and chronic pain (chronic all over body). Concomitant products included valaciclovir hydrochloride (Valacyclovir).   On 2nd January 2021, the patient received the 2nd dose of Shingrix. On 3rd January 2021, 1 days after receiving Shingrix, the patient experienced swollen glands, fatigue, chills and fever. On 4th January 2021, the patient experienced unexpected therapeutic effect. The patient was treated with paracetamol (Tylenol). In January 2021, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the swollen glands, fatigue, chills and unexpected therapeutic effect were unknown.   It was unknown if the reporter considered the swollen glands, fatigue, chills, fever and unexpected therapeutic effect to be related to Shingrix.  Additional details were provided as follows: The patient was using valacyclovir as treatment for genital herpes. The patient developed fever, chills, swollen glands and fatigue and self treated with Tylenol and bed rest. Two days later the patient experienced the unexpected benefit alleviation of chronic all over body pain, especially in the hands. The reporter consented to follow up.
Patient's left arm experienced redness, pain, stiffness, and swelling hours after receiving the vaccine; the arm was also very hot to the touch. The majority of his left upper arm was affected.  Patient took benadryl and ibuprofen for relief. Patient came back to the pharmacy on 9/9/17 to report the issue. His doctor was also notified and instructed patient to take benadryl and ibuprofen for symptoms. Patient is doing well, but still has some residual redness, pain, and stiffness.
I had a headache, body aches, fever (101.8- highest), nasal congestion, and a runny nose. I also experienced some fatigue and tiredness.
sore arm, felt like I had been punched very hard at the injection site beginning about 6 hours post-injection and continuing for about 10 hours, did not have full ROM during the soreness, also had a migraine begin at about the same time as the arm soreness
Received his second dose of Moderna today, he is 17; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received his second dose of Moderna today, he is 17) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-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 30-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received his second dose of Moderna today, he is 17). On 30-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received his second dose of Moderna today, he is 17) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.   This case was linked to MOD-2021-065078 (Patient Link).; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old male) for mRNA-1273 (lot number unknown) with no associated AEs reported.
-Patient given Flu shot & blacked out about 15 min later in store. Patient had faint pulse so given Epipen Jr. 0.15 mg & remained stable until EMT/paramedics arrived 5-10 min later. (shot given @ 12:45-black out at 1:00 pm) - patient taken to Montrose Mem. ER & discharged- patient doing well verified w/mom and RN @ hosp. (PT ok). Doing fine verified w/ mom.
Information has been received from the authors of the published literature abstract. The objective of the authors was to address a methodological challenge for studies of the safety of concomitant vaccination. Baseline risk of adverse events (AE) in young children changes quickly with age. Timing of same versus separate day vaccination was also associated with age. The authors showed how this can create bias and how to adjust for it. They re-examined the known increase in risk of seizure and fever 710 days after MMR vaccination. They sought to identify whether other vaccines (1) independently increase the risk of either AE or (2) potentiate risk when given concomitantly with measles-mumps-rubella (MMR). The authors began with multivariable analysis including all concomitantly administered vaccines to screen for vaccines associated with AE after adjusting for all others. For identified vaccines, they used overall and age-stratified chi-square tests to evaluate whether risk in the 710 day window was different for MMR by itself vs. MMR with same day vaccination. They then used conditional logistic models that accounted for modification of MMR's effect on AE by age at vaccination and evaluated whether risk was different for MMR if identified vaccines were administered on the same versus separate days. Finally, they estimated attributable risk for same versus separate day vaccination. The authors identified seizures (N = 2,747) in children aged 1125 months. Initial analyses suggested DTaP had both an independent and potentiating effect of MMR on AEs. After accounting for age, there was no evidence for either independent or potentiating effect on risk of seizure with same day administration (p > 0.3). For fever, there was evidence for increased risk with same day DTaP and MMR in children over 18 months; X^2 = 11.1, p = 0.001, but not in younger children. The outcome of the seizures were unknown at the time of reporting. Upon internal review seizures were considered to be a medically significant event. This is one of two reports from the same literature source, linked to case # 1709USA009303. Sender's Comments: US-009507513-1709USA009303.
Patient developed symptoms next day extreme drowsiness for 3 days problems with coordination loose stools. symptoms did resolve.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case was created for 81st of the 190 patients involved. Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 Vaccine. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
fever of 103 F degrees; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 103 F degrees) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever of 103 F degrees). At the time of the report, PYREXIA (fever of 103 F degrees) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Patient was given Pfizer vaccine as first dose and returned to clinic for 2nd dose and received Moderna. Patient did not have any adverse reaction.
4mo shots. High pitched crying x1 hour - inconsolable; slowly resolved over next hour - onset = 5 hours after injection - on follow up exam - family recalled similar incident after 2mo shots as well.
Hands, feet and face swollen to aprox 3 times their original size. Took Benadryl but did not help.
DISCOLORED REGION LOCATED 2 INCHES BELOW INJECTION SITE. RASH DEVELOPED BENEATH DISCOLORED REGION, SPREADING ~3INCHES IN AREA. NO TREATMENT SOUGHT.
slight headache,"crazy headache"/ headache on the right side of my head/ headaches began; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (slight headache,"crazy headache"/ headache on the right side of my head/ headaches began) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included Headache (in patient's young age in 30s and 40s). Concurrent medical conditions included Milk allergy. Concomitant products included AMLODIPINE for Blood pressure high, XANTOFYL, ZEAXANTHIN (EYE HEALTH EXTRA STRENGTH LUTEIN) for Eye disorder NOS, VITAMINS NOS and CALCIUM CITRATE for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (slight headache,"crazy headache"/ headache on the right side of my head/ headaches began). The patient was treated with MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HEADACHE (slight headache,"crazy headache"/ headache on the right side of my head/ headaches began) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient sawher doctor and had MRI done, but they did not find anything. Flonase was prescribed to treat her Symptoms. Patient has never been tested positive for COVID -19. Patient had no acute illness at the time of vaccination and up to one month before. Regarding headache patient mentioned sometimes it's intense and sometimes not so intense but it's always there.   This case was linked to MOD-2021-251769 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow-up information received contains Significant information Patient information, relevant history, dosage details, concomitant medication details, facility name, event onset date, event outcome and reporter causality updated.
Went into PCP on for a rash on 09/16. 09/22 went into PCP for ear infection. 09/28 tested positive for Flu. 10/01 began having extremely high fever and blue lips and extremities. 10/05 went into PCP and he was admitted to hospital for observation. Atypical Kawasaki disease with giant coronary aneurism. Hypertension and medium small cell vasculitis. He received 3 blood transfusions and two courses of IVIG. Multiple MRI, CT scan, bone marrow biopsy, multiple echocardiograms, and multiple blood tests. Continues blood pressure monitoring and 5 lead EKG. Have regular appointments and they have noted that his aortic aneurisms have enlarged but the physicians say it is expected with his condition. Have had two subsequent trips to the ER for blood pressure he was discharged home once and kept overnight once. His current meds are carvedilol, LOVENOX, co-trimoxazole, amlodipine, PEPCID, lisinopril, prednisolone, aspirin, CYTOXAN once monthly. Do not know what has caused all of these issues.
Bruising at injection site Severe body aches (joint, muscle) Headache Fever >100 degrees F Upset GI system (bloating, diarrhea)
Site: Pain at Injection Site-Medium, Additional Details: Patient stated the pain in her arm still exists from the vaccine
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 03-DEC-2015 the patient was vaccinated with dose of improperly stored VARIVAX (Merck) (incorrect product storage) (lot # K006135 with expiration date: 29-APR-2016) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The administered dose experienced a temperature excursion of 71 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. This is one of the many reports from the same source. Additional information has been requested.
left Ramsay Hunt Syndrome.  posterior auricular rash and L lower motor neuron type VII palsy.  Severe but improving as of 5/5/21
Five or six children devel red, swollen lumps @ the inject site; all the parents called to report the rxn & two of the children were seen in the office;
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the subject experienced expired vaccine administered.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
She reports that her arm became itchy, swollen, red, and hot from around the injection site down to her elbow within a day of receiving the injection, peaking at around 3-5 days after the dose, lasting about 10 days. It was painful enough at the peak to interfere with her daily activities. She took BENADRYL because she believed it might be an allergic reaction and to reduce the itching.  This helped a little, but not very much. As of now, she reports that the injection site is still itchy, red, and tender.
The patient presented to the clinic needing a Tdap vaccination. When the vaccination was taken out of the fridge,  Pentacel was taken out and administered instead of regular Tdap. Staff with Department of Health was notified. She got back in contact with our office to let us know that the patient will not need to come back in for a regular tdap, as the pentacel covers as well as regular tdap. Actions to be taken are to report the incident to VAERS and to notify the patient's mother.
Patient reports arm warm, swollen; Fever; Chills; decrease ROM. We had another patient have a reaction from the same office. For both they have a history of Neutropenia. Td was given at the same time as this vaccine.
Seen 2 days after shot-right arm swelling from shoulder to wrist, redness on upper arm-tight swelling with central area on upper arm pale "waxy" looking around shot site abut 3x3 inch area.
The pt was given 1 dose of pneumovax 23 valent on 11/26/01. (The pt claims this was the 1st time he had ever received this). On 11/28/01, the pt presents with a swollen, red, enlarged, rash on arm at the injection site.
12Jun90 pt vax;  15Jun90 devel urticaria.  24Jun90 urticaria worsened.  Seen by MD w/ red, raised, macular rash on trunk.
No adverse event; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in an 86-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051d22a) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: COVID-19 VACCINE on 04-Mar-2021, COVID-19 VACCINE on 01-Apr-2021, COVID-19 VACCINE on 04-Nov-2021 and COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE, COVID-19 VACCINE, COVID-19 VACCINE and COVID-19 VACCINE.    On 15-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 15-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    NO Concomitant medication was provided by reporter. No Treatment medication was provided by reporter.
This spontaneous report as received from a healthcare student refers to a 63 year old male patient. On 09-AUG-2013 the patient was inadvertently vaccinated with first dose of GARDASIL (120 Y, site, route, dose not reported). No adverse symptoms reported. Additional information has been requested.
This spontaneous report was received from a physician via a company representative and refers to a 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant drugs were not reported. On 14-MAR-2019, the patient was vaccinated with a dose of ROTATEQ orally, lot# R034700, expiration date 16-JUN-2020 (exact dose and frequency were not reported) for prophylaxis. On an unknown day in March 2019 (reported as about 8 hours later) the patient experienced fever "of 102" which resolved on an unknown date in March 2019 (reported as within 24 hours). The relatedness between the event and ROTATEQ was not reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1903USA010123.
Muscle pain; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was unknown.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced muscle pain right after taking the first dose. This case has been linked to US2020041868, reported by the same reporter.
Information has been received via a literature citation, title as stated above, concerning a child who on an unknown date was vaccinated with VARIVAX (Oka/Merck).  Subsequently, the patient developed acute posterior multifocal placoid pigment epitheliopathy.  Upon internal review, the patient's acute posterior multifocal placoid pigment epitheliopathy was considered an other important medical event.  Additional information has been requested.  A copy of the published literature article will be provided when available.
Received second vaccine on 2/4/21 and on 2/8/21 went to urgent care for bilateral ear pressure and sinus congestion that was present since 2/7/21.
Very fast heart rate for 5 hours, I thought I was having a heart attack. Now I have pain in my heart while walking for a long distance at a somewhat accelerated speed.
Sweats, fever, emesis treated by personal physician with Benadryl and Cipro x 3 days.