chrisvoncsefalvay/vaers-outcomes huggingface dataset:
exhaustion; stiffness; uncomfortable to walk or roll over; incapable of lifting injection arm; Beginning the evening of vaccine, incredibly uncomfortable body aches.; This is a spontaneous report received from a contactable reporter (Other Healthcare Professional). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 27Feb2021 15:00 (Lot number: EN6206) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Acne cystic" (unspecified if ongoing); "Allergy to codeine" (unspecified if ongoing), notes: Known Allergies: Codeine. Concomitant medication(s) included: PROBIOTICS. The following information was reported: PAIN (non-serious) with onset 27Feb2021 20:00, outcome "recovered" (2021), described as "Beginning the evening of vaccine, incredibly uncomfortable body aches."; FATIGUE (non-serious) with onset 28Feb2021, outcome "recovered" (2021), described as "exhaustion"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 28Feb2021, outcome "recovered" (2021), described as "stiffness"; GAIT DISTURBANCE (non-serious) with onset 28Feb2021, outcome "recovered" (2021), described as "uncomfortable to walk or roll over"; VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious) with onset 28Feb2021, outcome "recovered" (2021), described as "incapable of lifting injection arm". Therapeutic measures were not taken as a result of pain, fatigue, musculoskeletal stiffness, gait disturbance, vaccination site movement impairment. Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID Vaccine and received probiotics daily within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient has reported allergies to codeine (reported as codiene).  No follow-up attempts are possible. No further information is expected.
pt recvd vax & following morning pt ate, played & took a nap then father checked & found not breathing; cpr performed; initially resusitated at hosp then transferred;
Pt. reported that she had blisters around her mouth. She reported that she could taste the vaccine. She waited 15 minutes in the pharmacy and was fine. When she got home this occurred and it took a week to clear up. She used CAMPHO-PHENIQUE.
This is a 63-year-old male veteran arriving via private vehicle with the sensation that his tongue and throat or swelling. He had a very sudden onset of feeling a chest fullness like he was filling up with fluid. He denies any chest pressure. He does have some injection of the eyes. He felt well all day today. He had a flu shot at about 10:30 this morning. He felt well at that time flu shot was in the left ureter here clinic in deltoid area. This episode occurred at about 1:40 PM this afternoon. It occurred very suddenly. At 7 and lasting for about 2 hours and was not getting better so he came to the emergency department for further evaluation. He has no known cardiac issues that are under treatment at this time.
Skin: right arm: 3 in. by 2.5 in erythema, skin feels warm, taut to touch, no fluctuance. Redness covers about 2/3 of outer arm.
On reported date 2/9/2021, I started having idiopathic pain in my lower left jaw, this pain slowly increased and spread to entire left side of mouth and into the left cheek. Within three days, I had trigeminal neuralgia pain shooting through my left cheek, left side of jaw as well as over my left eye.
Patient received  Tdap, Meningococcal Conjugate Quadrivalent (Left Deltoid) and HPV (Right Deltoid) vaccines today during well visit. Upon completion of vaccines, after leaving room and walking to check out, patient stated to parent that he could not feel his hands and heard "noises". Parent escorted patient to a seated position in chair while Patient Service Specialist  notified Registered Nurses. RNs immediately responded. Patient instructed to lay down on parent, was pale at this time. Patient provided with apple juice, ice water and a cool wash cloth for forehead. Patient's skin color began to return and stated that he could feel his arms again after resting and having some juice. Stated that he no longer was hearing noises. Patient was then instructed to sit up into a seated position to see how he tolerated. Reported that he felt better. After approximately 5 minutes, was instructed to stand. Upon standing reported that he felt fine. Patient then remained seated in lobby for an additional 10 minutes prior to leaving. Reported at check out while stating that he was better.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information on patient's medical history or concurrent conditions was provided. On an unkonwn date, the patient was vaccinated with a dose of VARIVAX (Merck) lot # K002047, expiration date 10-FEB-2016 (strength, dose and route of administration were not reported) that were improperly stored. No information on patient's concomitant medication was provided. No adverse effects were reported. This is one of the two reports from the same reporter. Additional information has been requested.
Information has been received from a nurse concerning a 17 year old female patient with no drug allergies or pertinent medical history who on 14-JAN-2010 was vaccinated with the first dose of GARDASIL (lot # 663454/0672Y) (route not reported). On 16-SEP-2011, the patient received the second dose of GARDASIL (lot # 666931/0337Z) (route not reported) while pregnant. At the time of the report the patient was 33 weeks and 4 days pregnant. An ultrasound was performed. The last menstrual period (LMP) was on approximately 17-MAR-2011. The estimated delivery date would be on 22-DEC-2011. No adverse effect was reported. Concomitant therapy included prenatal vitamins (unspecified). Follow up information has been received from the infant's pediatrician via initial pregnancy questionnaire concerning the female patient with no known medical history or concurrent conditions and an obstetrical history of 0 pregnancies. Concomitant  therapy also included ferrous gluconate, prenatal vitamins and docusate. It was reported that on 07-NOV-2011 at 33 weeks pregnant, the patient had an ultrasound done due to late care that resulted normal. The patient denied being sexually active before given her GARDASIL vaccine. The nurse also reported that the patient had normal routine tests. On 31-DEC-2011, the patient delivered a female baby via C-section due to failure to progress. The baby's weight was 6 pounds 11 ounces, her length was 20 inches, head circumference 13 inches and Apgar score 9-9. The registered nurse reported that the baby's right hand was absent. No other complications or abnormalities were reported and no infections or illnesses during pregnancy. Upon internal review C-section due to failure to progress was determined to be an other important medical event. The baby's experiences were captured in WAES # 1111USA00983B1. Additional information has been requested.
Left side acute abdominal pain, severe constipation,  acute pain in left collarbone, painful swollen mass in left armpit, swollen mass in left collarbone.
10 days following vaccine (Sun 1/2/2022), I developed itchy sensations all over my skin, in different places, as well as tingling and pain in my hands and fingers. Anywhere I scratched broke out in hives and became even more itchy.  The next day (Mon 1/3/2022), the itching continued with pain in my hands. ER visit that same night due to unusual swelling of skin under my chin and jawline. Started double-dose of Benadryl up to 4x daily, plus prednisone daily for the next few days. Topical moisturizing lotions and anti-itch creams, but little relief thus far.
Fever, Congestion, Cough, Muscle Ache, Headache, Lethargy and Nausea
After the injection my arm started to hurt instantly. It hurt off and on for a few weeks. Some days I was unable to lift my arm above my head. So I had to see an orthopedic Dr. and he gave me a cortisone shots.
Severe Depression Irritability Unstable Mood  Low Mood Lethargy Confusion High Anxiety Muscle spasms/involuntary movement Twitching 2-3 months after receiving the second dose of the Moderna Vaccine it became evident that I was suffering most if not all of the symptoms above. I was unsure at first due to the fact that I have prior diagnoses for mental disorders and I wasn't sure until I started to get a feeling something wasn't right. I wasn't told about any side effects in this category or magnitude.  The most prevalent side effects are irritability, depression and lethargy, but all of these reported we're recognized at the time frame stated above and are all currently affecting me at this time. There haven't been any treatments yet, but I will be making an appointment to see a psychologist for these symptoms.
2 hrs post vax returned to clinic w/ c/o pain lt arm & across upper chest; exp heart palpitations in the evening & temp of 103; next day kept in phone contact w/pt thru the weekend plus called MD;
fever and chills, headache, fatigue, loss of appetite, vomited 3 times
Muscles Aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscles Aches) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) film-coated tablet for Mantle cell lymphoma.    Concurrent medical conditions included Blood pressure high, High cholesterol, Type II diabetes mellitus, Prostate cancer, Non-tobacco user, Abstains from alcohol, Mantle cell lymphoma and Vitamin B1 supplementation. Concomitant products included RAMIPRIL (ALTACE) for Blood pressure high, ATORVASTATIN CALCIUM for High cholesterol, METFORMIN HYDROCHLORIDE for Type II diabetes mellitus, CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]) for Vitamin B12 supplementation.   In 2019, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 2022, the patient experienced MYALGIA (Muscles Aches). At the time of the report, MYALGIA (Muscles Aches) had not resolved.            No known allergies were reported. Primary reporter did not have the lot number information, because the packaging was discarded. MPID number was given as 4782590. Patient was not enrolled in a COVID-19 Vaccine Trial. No treatment medication was reported.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as form 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of VAQTA (dose number, dose, route and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information has been requested.
Left sided headache and facial pain. Shooting pain with any transitional movement and with chewing. Throbbing over temple which worsens with neck extension or left rotation. Pain progresses down my neck and into my left shoulder. Pain occasionally goes towards my left eye. Pain has persisted since 1/21.
Pt experienced a rash/erythema, pruritis, edema approximately 30 hours post injection. Pt also experienced a swollen eyelid, 5 x 9 cm on right lower quarter patch of abdomen. 7x7 cm left lower quarter of abdomen. No wheezing, no pharyngeal edema. Symptoms resolved with steroid treatment. No systemic involvement.
This case was reported by a consumer via call center representative and described the occurrence of pain in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced pain and injection site pain. On an unknown date, the outcome of the pain and injection site pain were recovered/resolved. It was unknown if the reporter considered the pain and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported however it could be 83 or 84 years. The patient could not remember what arm she received the first injection. The patient experienced achiness and a dull throbbing at the injection site that started within one hour of receiving the vaccination. Achiness and throbbing at the injection site were resolved within two to three days. The reporter gave permission to contact their physician. The reporter was unable to provide additional information. This case has been linked with cases US2018153589 and US2018GSK158507, reported by same reporter.
Site red/swollen, patient felt warm ("but not burning up") last night so mom gave him a dose of ibuprofen and he has not felt warm ever since (mom denies any other possible reactions).
Arm soreness at location of injection Chills Fever Achy muscles  Swollen neck area, maybe swollen lymph node  No appetite
body ache; soreness of the injection site and slight body ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache) and VACCINATION SITE PAIN (soreness of the injection site and slight body ache) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04A821A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced PAIN (body ache) and VACCINATION SITE PAIN (soreness of the injection site and slight body ache). At the time of the report, PAIN (body ache) and VACCINATION SITE PAIN (soreness of the injection site and slight body ache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were reported.   Treatment information was not provided.    This case was linked to MOD-2021-072506 (Patient Link).
Bad neck pain.  Cracking and radiating to both shoulders.  CANNOT be 100% sure it is related to vaccine, but happened just after and I have never had neck/back pain in my life.  Still persists (6/19/21).  Seems to be worse when I sit at my desk (posture) but I wanted to report just in case.
12 year old patient was administered an expired Menactra, no AE; Initial information regarding an unsolicited valid non-serious case was received from the other healthcare professional via Medical Information inbound (reference number-00613470) and transmitted to Sanofi on 24-May-2021.  This case involves a 12 year old female patient who was administered an expired 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: U6576AB; expiry date: 04-APR-2021) via intramuscular route in the left arm for prophylactic vaccination on 24-MAY-2021 (expired product administered).  Medical history, medical treatment(s), past vaccination(s), and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) for prophylactic vaccination.   It was a case of an actual medication error due to expired vaccine used (latency same day).  The reporter was asking for appropriate follow up.    At the time of report, no adverse event was reported.  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 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.
A  female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 26Apr2021 at 10:00 (Batch/Lot number was not reported)(at the age of 93-year-old) as single dose for COVID-19 immunisation.  Medical history included anaphylactic shock and blood cholesterol abnormal, both from an unknown date and unknown if ongoing and total knee replacement in 2009. Concomitant medications included simvastatin taken for blood cholesterol abnormal, start and stop date were not reported; furosemide (LASIX) taken for diuretic therapy, start and stop date were not reported and potassium taken for an unspecified indication, start and stop date were not reported.  The patient reported that around on 26Apr2021 at 21:00 she experienced diarrhea. She said that she has had it 8-10 times, and she was just a little bit nauseous. The patient outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient had a sore arm for a day or so. She went to pick up an object and her hand "felt like it belonged to someone else". Her hand went numb and stayed that way for 1-2 hours. She said her brain was foggy too. She recovered but she does not want the second dose. Everything cleared up at the same time.
Morning of Monday, May 24, woke up with 4 small pimples on my right side of my face and slight cramping. Period started Friday, May 28, around 10pm, heavier than usual. Currently having a small bout of acne on my face and very heavy cramping, which is not usual along with my cycle.
Pt requested Pfizer Bivalent vaccine booster.  Pt had already received primary series of Pfizer.  Due to a misreading of the vial, the pt was vaccinated with a Pfizer monovalent vaccine rather than a Pfizer bivalent vaccine.  Once mistake was recognized, this reporter contacted the staff physician and discussed events and follow-up with pt.  Pt reported understanding of situation and follow-up instructions.
I experienced a missed miscarriage. I was pregnant during both doses of the vaccine (1st dose 1/15/21), but 2/12/21 (the day of the 2nd dose) was the day the gestational sac stopped growing. I was 8 weeks pregnant at this point. The ultrasound was on 2/17/21 and it was reported that I was supposed to be 8wk 6days, but gestational sac was only 8wk 1day. I was due on 9/23/21.   My PCP encouraged me to get the vaccine, knowing that I was pregnant. So I did.   Upon receiving my 2nd dose of the vaccine, I did not experience any symptoms and believe that my body was focused more on the vaccine than the development of the baby. Obviously I'm not positive that this was the cause, but I wanted to make it known, so I can hopefully prevent this from happening again, if the vaccine was indeed a contributor.
almost immed started having deep throbbing pain @ site of inject; cont almost daily thru present time;
This spontaneous report as received from a certified medical assistant, refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX lot# L006384, expiration date: 25-FEB-2017 (dose and route not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
pt states that 1 day after vaccine, she couldn't move her legs and couldn't get out of bed. swelling in legs, mostly right side. doctor gave her diuretics, and natural medicines. she is taking advil. she got some sort of electric shock? treatment. she is walking and talking to me today
LYMPH NODE ON LEFT SIDE OF NECK SWOLLEN, TENDER TO TOUCH. HAS BEEN 19 DAYS, PT WONDERING WHEN IT WILL SUBSIDE AND IF HE SHOULD GET THE SECOND VACCINE OF THE SERIES OF 2.
On 4/18/13 patient vomited then became pale & lethargic, O2 sat was 97%, HR 117, BP 90/42, BG 82, patient was lethargic for several minutes then began crying when BP was taken. Patient was sent to ED. Per mom, patient had similar episode on 3/13/13 when she received the following vaccines: Hib, flu, PCV13, Rota. Mom did not bring her in on 3/13 & patient did better without intervention. Patient was admitted with dx of syncope.
like having the flu but 3 times worse; pretty sick; 3 times worse in May or June after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (like having the flu but 3 times worse), ILLNESS (pretty sick) and CONDITION AGGRAVATED (3 times worse in May or June after receiving the vaccine) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (like having the flu but 3 times worse), ILLNESS (pretty sick) and CONDITION AGGRAVATED (3 times worse in May or June after receiving the vaccine). At the time of the report, INFLUENZA LIKE ILLNESS (like having the flu but 3 times worse), ILLNESS (pretty sick) and CONDITION AGGRAVATED (3 times worse in May or June after receiving the vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.  Patient was given a z-pack for his illness.
patient was due for his second dose of pfizer on the 28 of this month. parent got him to the pharmacy today. I didnot notice the date it was given on . so patient got his second dose 8 days earlier then he should
been 3 months since I had the first dose.  Can I still get the second dose?; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (been 3 months since I had the first dose.  Can I still get the second dose?) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (been 3 months since I had the first dose.  Can I still get the second dose?). At the time of the report, PRODUCT DOSE OMISSION ISSUE (been 3 months since I had the first dose.  Can I still get the second dose?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported. No treatment information's was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: non-significant follow-up. no new information provided.; Reporter's Comments: Med Info Agent:  AE submitted with chatbot.  It's been 3 months since I had the first dose.  Can I still get the second dose? Consent for follow up accepted.