chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills all night long; Muscle pain on the inside of the legs up to the thighs; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills all night long) and MYALGIA (Muscle pain on the inside of the legs up to the thighs) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Relevant medical history was provided.  Concomitant products included CLOPIDOGREL for an unknown indication.   On 17-Apr-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 17-Apr-2021, the patient experienced CHILLS (Chills all night long) and MYALGIA (Muscle pain on the inside of the legs up to the thighs). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, CHILLS (Chills all night long) and MYALGIA (Muscle pain on the inside of the legs up to the thighs) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Updated reporter address
This spontaneous case was reported by another health care professional and describes the occurrence of UNDERDOSE (Patient received 0.25mL of Moderna COVID-19 Vaccine, Bivalent.) 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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient received 0.25mL of Moderna COVID-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient received 0.25mL of Moderna COVID-19 Vaccine, Bivalent.) 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 UNDERDOSE (Patient received 0.25mL of Moderna COVID-19 Vaccine, Bivalent.).    No concomitant medication information was provided.  196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.  It was unknown that the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up received updated age group.
Received yellow fever vaccine on 4/25/14. Received hepatitis A vaccine on 4/21/14 through primary care. On 4/26/14, pt. developed itchy rash on back, trunk, neck, back of knees, and inner elbows, inner thighs, fever of 100 degrees, headache and muscle aches. Her rash went away that evening after taking Benadryl. On 4/27/14, she woke up with yellow discoloration underneath her eyes. No yellow of eye sclera noted. These symptoms were reported by mother. Pt continued her regular activities while symptomatic and symptoms are now totally resolved.
LOWER BACK PAIN; LEG MUSCLE PAIN; HEADACHE; This spontaneous report received from a consumer concerned an 18 year old male. 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: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 14:00 at left arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced lower back pain. On 03-APR-2021, the subject experienced leg muscle pain. On 03-APR-2021 02:00, the subject experienced headache. Treatment medications (dates unspecified) included: oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lower back pain, headache, and leg muscle pain. This report was non-serious.
Flu Symptoms (Chills, Severe Body Aches, Headaches, Nausea, Night Sweats)
On 9/11, pt's mom called and said started with raised vesicles on skin of face on 9/9/00. Vesicles erupt with watery discharge spreading to bilateral arms with itching. Seen illness acute visit on 9/11/00 and was dx'd with mild case of chickenpox.
Patient was supposed to get adult Pfizer booster but was injected with pediatric Pfizer booster
sixteen hours after following the vaccination I became incoherent and unresponsive. An ambulance was called and was taken to the local Hospital and treated for numerous isses.
No additional adverse events reported; the administration of expired VAQTA; This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 02-MAR-2021 the patient was vaccinated with expired hepatitis a vaccine, inactivated (VAQTA) lot # S036494 with expiration date on 09-JAN-2021 (exact dose, route of administration were unknown) for prophylaxis. No adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S036494; expirationdate: 09-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Works as healthcare provider who had Moderna booster on 8/27/21. Onset uticaria 9/18/21 after receiving hair dye treatment from hairdresser. Has tried antihistamines, but symptoms have not resolve. Diagnosis: dermatographic urticaria; Plan: pepcid and desloratadine bid x 30 days. Future: consider addition of Singulair. Patient to contact office if no improvement in symptoms.
chronic reflux, inability to be laid on back, irregular and painful bowel movements (sometimes 8 days apart), cross-eyed irregularities, sharp body jerks/reactions inconsistent with normal infant reflexes, chronic arching of back due to stomach pain, frightening irregularities of breathing conflicts that have required intervention to correct (almost as if he has forgotten how to breathe and is suffocating, causing facial discoloration)
Vomited 3 times; Whole body started trembling and could not stop it; Severe chills/still freezing; A little bit of arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A little bit of arm pain), TREMOR (Whole body started trembling and could not stop it), CHILLS (Severe chills/still freezing) and VOMITING (Vomited 3 times) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Splenectomy (5-6 years ago had his spleen remove to stop proteins from attaching to his platelets.). Concurrent medical conditions included CLL (10 years now). Concomitant products included METFORMIN and INSULIN GLARGINE (LANTUS) for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (A little bit of arm pain). On 16-Mar-2021, the patient experienced TREMOR (Whole body started trembling and could not stop it) and CHILLS (Severe chills/still freezing). On 17-Mar-2021 at 2:00 AM, the patient experienced VOMITING (Vomited 3 times). At the time of the report, PAIN IN EXTREMITY (A little bit of arm pain), TREMOR (Whole body started trembling and could not stop it) and CHILLS (Severe chills/still freezing) outcome was unknown and VOMITING (Vomited 3 times) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood test: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not reported. Concomitant medication includes- ultra 2 vitamins. Patient weight-213
This spontaneous report was received from a registered nurse and refers to a 17-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 21-DEC-2018, the patient was vaccinated with improperly stored dose of VAQTA, lot # R018935, expiration date 05-SEP-2019 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (It was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Patient was incorrectly given the Pfizer -BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) for Age 12y & older, a 0.2 mL, instead of the Pfizer-BioNTech COVID-19 Vaccine for age 2y to <5y.  No adverse reaction to the vaccination at time of administration or within 1 hour of administration, patient's guardian's advised to watch for signs of allergic reaction and follow up if they occur.
on day 8 ,post vaccination I had a hard, raised bump at injection site which looked like an insect bite but it was not itchy. on day 9, I developed a hard, raised rash under vaccination site approximately 3 inches by 2 inches. It started out as bright red, itchy at touch, and warm to touch. Nothing was taken by mouth or applied to rash. on day 10, rash faded in color and was no longer itchy or warm to touch. It was still raised and had shrunk about a 1/3 inch. The raised bump at injection site has resolved.
Passed out 3 times after Moderna vaccine; hair thinning; dry skin and nose; dry skin and nose; muscle spasm in back; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out 3 times after Moderna vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product PALBOCICLIB (IBRANCE) for Breast cancer.    Concurrent medical conditions included Breast cancer, Acute cystitis, Anxiety, Lipid metabolism disorder NOS, Unspecified disorder of thyroid, Dizziness, Giddiness, Hyperlipidemia, Hypokalemia, Pure hypercholesterolemia, Thyrotoxicosis, Acquired hypothyroidism, Urinary tract infection, Drug allergy (Allergy to Amoxycillin), Drug allergy (Allergy to Sulfa) and Drug allergy (Allergy to Penicillin.). Concomitant products included DOCOSANOL (ABREVA), ANASTROZOLE, ATORVASTATIN CALCIUM, CALCIUM CARBONATE, COLECALCIFEROL (CALTRATE +VIT.D), MECLIZINE HCL, PROCHLORPERAZINE MALEATE, ZOLEDRONIC ACID MONOHYDRATE (ZOMETA) and LEVOTHYROXINE SODIUM (SYNTHYROID) for an unknown indication.   In February 2021, the patient started PALBOCICLIB (IBRANCE) (unknown route) 125 milligram. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passed out 3 times after Moderna vaccine) (seriousness criterion medically significant), ALOPECIA (hair thinning), DRY SKIN (dry skin and nose), NASAL DRYNESS (dry skin and nose) and MUSCLE SPASMS (muscle spasm in back). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out 3 times after Moderna vaccine), ALOPECIA (hair thinning), DRY SKIN (dry skin and nose), NASAL DRYNESS (dry skin and nose) and MUSCLE SPASMS (muscle spasm in back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that the co-suspect drug Ibrance (palbociclib) was taken once daily for 21 days.  The patient reported that she went to ER (emergency room) for "passing out".   No treatment information was provided.  Very limited information regarding these events has been provided at this time. The patient's medical history and con meds are confounders.; Sender's Comments: Very limited information regarding these events has been provided at this time. The patient's medical history and con meds are confounders.
Patient recieved  Pfizer dose on 08/13/2021.  Patient's mother who also works in the pharmacy calls and ask for moderna for second dose. Without checking prior history, the pharmacist administered moderna  as the second dose on 09/3/2021. The OBGYN is aware of the incident.  Patient didn't have any adverse events .  Patient delivered the baby on 14th or 15 th of September
administered an expired Fluzone quad vaccine with no reported adverse event; Initial information received on 21-Oct-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to case 2022SA442254 and 2022SA443067(CLUSTER).  This case involves a 15 years old male patient who administered an expired fluzone quad vaccine with no reported adverse event while receiving vaccine influenza quadrival A-B vaccine [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 20-Oct-2022, the patient received suspect INFLUENZA QUADRIVAL A-B VACCINE at a total dose of 0.5 ml (lot UJ776AA, expiry date: 30-Jun-2022) (strength: standard) via intramuscular route in the left deltoid for immunization.  On 20-OCT-2022 the patient administered an expired fluzone quad vaccine with no reported adverse event (expired product administered) (Latency: same day)  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
On the night of the vaccine had fever, received OTC antipyretic x1 with no further fever On the next day she had arm soreness and myalgias: resolved On the fourth day she had vomiting and abdominal pain + rhinorrhea, no fever. Covid/flu/strep negative. and appears to have viral illness
This 83 year old female received the Covid shot on  1/28/21  while under hospice care and went to the ED and admitted 2/4/21 and again on 3/3/21 and again on 3/25/21 and 4/15/21 died on  4/24/21.  GI bleed, duodenal ulcer with hemorrhage, SIRS (systemic inflammatory response syndrome, shortness of breath, acute heart failure, acute respiratory failure, cough, pleural effusion.  Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age and gender. On an unknown date, roughly 20 unspecified patients were vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, the reporter stated that their in house stability data could support those conditions mentioned above that VARIVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow-up information which has been unsuccessful) has been received from nurse concerning VARIVAX temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012384, exp date: 31-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports from the same source. Additional information has been requested.
Vaginal Dryness; Pain initiating at vaginal area; Inappropriate schedule of vaccine; This case was reported by a nurse via call center representative and described the occurrence of vaginal dryness in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number M77B4, expiry date 18th February 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 2nd August 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced vaginal dryness, vaginal pain and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the vaginal dryness and vaginal pain were recovered/resolved and the outcome of the inappropriate schedule of vaccine administered was unknown.   It was unknown if the reporter considered the vaginal dryness and vaginal pain to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix initially and experienced vaginal dryness and pain that had lasted several months. The patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. No further information provided.
Agitation, Depression, Myalgia, sore right arm Narrative: Employee states, "I did experience the sore arm, though mine lasted about a week. I received my vaccine the morning of the 21st and by the evening I was experiencing what I have been called "tantrum moodiness". Short fuse, unreasonably angry, felt like crying, yelling, arguing. By the next day some general malaise that led to aching, especially it seemed in connective tissue. More moodiness, crying, some yelling. By Wednesday it seemed to resolve."
A few minutes after vaccination patient had scratchy throat and a metallic taste in her mouth.  Normal vital signs.
Fever; Chills; Headache; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Body Aches) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 27-Jan-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). 27-Jan-2021, the patient experienced MYALGIA (Body Aches). At the time of the report, PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Body Aches) outcome was unknown.            Treatment and concomitant medications were not provided by reporter.
Information has been received from a registered nurse concerning a 13 year old female who on 06-NOV-2006 and on 09-JAN-2007 was vaccinated with a first and second dose of HPV. Subsequently the patient experienced irregular menstrual bleeding. Unspecified medical attention was sought. Additional information has been requested.
He thinks the vaccine may have affected the Mefalamine or something.; Caller stated he was not eating much but did eat a banana, yogurt, and apple sauce.; States that something in the vaccine aggravated his Crohn's or Ulcerative Colitis.; lost weight; This is a spontaneous report from a contactable consumer (patient herself). A 71-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on 15Mar2021 18:30 at single dose for covid-19 immunisation. Medical history included ongoing crohn's disease, colitis ulcerative. Concomitant medication included mesalamine taken for crohn's disease, colitis ulcerative from 15Feb2021.The patient underwent lab test blood cholesterol was abnormal. The patient experienced he thinks the vaccine may have affected the mefalamine or something (drug interaction), caller stated he was not eating much but did eat a banana, yogurt, and apple sauce, states that something in the vaccine aggravated his crohn's or ulcerative colitis, lost weight on an unspecified date. On Sunday 21Mar2021, he had a bout with vomiting, stomach pain, chest pain, back pain, skeleton pain on the right side. Caller stated he felt constipated and needed to go to the bathroom. When he finally went to the bathroom it was not solid or compacted, it was more stringy and long. Caller stated it was hard to swallow water and the pill he takes for Crohn's or Ulcerative Colitis, which is Mefalamine. Caller stated he was not eating much but did eat a banana, yogurt, and apple sauce. He thinks the vaccine may have affected the Mefalamine or something. He stated he felt lousy. He said he still feels weak. Caller stated he does not know his current weight but he has probably lost weight because of not being able to eat much and the vomiting. Caller stated he started vomiting at 7:00PM on Sunday 21Mar2021 until 7:00-10:00AM Monday morning. Caller stated the first time he vomited was at 7:00PM and it was solid. It looked like the banana, apple sauce and yogurt he had ate, brown in color. The second time he vomited it was a green liquid, like bile from the stomach. States that something in the vaccine aggravated his Crohn's or Ulcerative Colitis. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
12 minutes post vax felt warm, dizzy, hypotensive, syncope.  Transferred to ED, monitored and discharged. On 12/24/2020 developed cyanosis to lips. Returned to ED and placed on 5 day steroid therapy and diphehydramine. Mildly improved.
Severe pulsation type feeling in his head, unlike a usual headache, associated with "brain fog" and night sweats. Denied fever. Sx persisted for 3 days. Similar symptoms with AVA # 1 admin on 07 Feb 15, but those sx were mild in comparison to this episode. Vaccination site tender with a small red knot.
Injection administered too high. Is directly under the acromion process, approx 1 finger width below. Injection site is also not centered on arm.  Pain within 1 hour. Increased pain throughout the day unlike the first dose. Decreased range of motion  Pregnant- 32.0 weeks
Patient received J&J vaccine 4/1/2021. After she had left arm pain. She continued to monitor, but her arm pain has persisted for the last two weeks. TTP of left deltoid. She now has a feeling of warm in her arm at times. And several days ago started to have tingling in first 2-3rd fingers.
Redness and swelling of right arm with hives, fever 101, fatigue, pain.
hives (R) leg evening after vaccines 24 hrs later hives ON trunk, face, (L) & (R) leg