chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I'm exceptionally tired; This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (I'm exceptionally tired) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 067E21A, 021B21A and 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (I'm exceptionally tired). At the time of the report, FATIGUE (I'm exceptionally tired) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 25-Oct-2021 patient took first booster dose. On 26-Apr-2022 patient took second booster dose. Patient did not experienced a similar event in the past. Patients allergies were unknown. The AE did not cause patient to seek medical care. No treatment details were reported.   This case was linked to MOD-2021-067305, MOD-2021-067552 (Patient Link).
started feeling bad this am and have gotten progressively worse.  Temp 101.3  Heart rate 136 Could not warm up.  Head ache, ears hurt, throat and nose dry, General aches, tired
Significant coughing, inspiratory stridor, hoarseness, runny nose, (facial) swelling of the right upper eye lid
The patient was vaccinated in right arm and that night the pain started; The patient rubbed her arm against something, and the pain came back; Barely lift arm due to pain; This spontaneous case was received on 14-Sep-2020 from other non-health professional via agency (reference number: SEQW20-01618) with additional document received the same day from pharmacist (being processed together) and concerned a 64-year-old, female patient.  The patient's concurrent condition included arthritis in left shoulder diagnosed several years ago. The patient was always getting pain after unspecified vaccines in the past which would go away after 2 days. The patient reported that the pain was in muscle.   On 03-Sep-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, anatomical location: right arm, route of administration and dose: not reported) for influenza prophylaxis. The batch number reported was P100242856 and expiry date was 20-Jun-2021.  On the same day, that night after receiving Afluria Quadrivalent, the patient started experiencing pain in right arm.   On 05-Sep-2020, the pain went away.   On an unspecified date in Sep-2020, the patient rubbed her arm against something, and the pain came back. The patient could barely lift her arm due to pain that was off and on. The patient connected this pain with the past pain from vaccines.  At the time of this report, no treatment was used. The patient was still sore form the vaccine.  At the time of initial reporting on 14-Sep-2020, the patient had not recovered form events.   The reporter assessed all events as related to Afluria Quadrivalent vaccine.   The case was assessed as non-serious.  Company comment: The patient developed pain in extremity on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is suggestive. Reportedly, on an unspecified date within same month, the patient rubbed her arm against something and the event of pain in extremity reoccurred, along with injected limb mobility decreased. No alternative aetilogy was provided. Considering all above mentioned, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Reporter's Comments: The patient stated that she was still sore from the vaccine.; Sender's Comments: The patient developed pain in extremity on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is suggestive. Reportedly, on an unspecified date within same month, the patient rubbed her arm against something and the event of pain in extremity reoccurred, along with injected limb mobility decreased. No alternative aetilogy was provided. Considering all above mentioned, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            The  concomitant medications on use were not provided. No treatment information was provided.   This case was linked to MOD-2022-467290, MOD-2022-467315 (Patient Link).
Mom states that patient vomited 5-6 times over 2 days. She did not have a fever. She was crying quite a bit and seemed off balance. She did end up with a rash over her body on Friday evening.
SHAKING; RESPIRATORY ALLERGIES; COUGHING; ARMPIT PAIN; INSIDE OF PALM FELT WEIRD WITH DULL PAIN; TIRED; HIVES ON SKIN; STRONG HEADACHE; FELT NAUSEOUS; FEVER; This spontaneous report received from a patient concerned a 20 year old female. 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: 1808982, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 16:30 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced respiratory allergies. On APR-2021, the subject experienced cough. On APR-2021, the subject experienced armpit pain. On APR-2021, the subject experienced inside of palm felt weird with dull pain. On APR-2021, the subject experienced tired. On APR-2021, the subject experienced hives on skin. On APR-2021, the subject experienced strong headache. On APR-2021, the subject experienced felt nauseous. On APR-2021, the subject experienced fever.  Laboratory data included: Body temperature (NR: not provided) 103 F.  On 09-APR-2021 20:30, the subject experienced shaking.  Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking on 09-APR-2021 21:30, and strong headache, and fever, had not recovered from armpit pain, and the outcome of hives on skin, cough, respiratory allergies, felt nauseous, tired and inside of palm felt weird with dull pain was not reported. This report was non-serious.
Information has been received from a registered nurse concerning multiple unspecified amounts of children of unknown age and gender. On an unknown dates, the children received doses of improperly stored PROQUAD (Merck) (lot # L030586 with expire date 10-FEB-2017) (dose and route unspecified). The vaccines were stored in refrigerator temperature of 36 to 46F for 48 hours. Then they were stored at 48.7F for 18 minutes. There was no previous temperature excursion. No adverse effect was reported at this time. This was one of several reports received from same reporter. Additional information is not expected because the reporter refused additional contact.
pt recvd vax & fainted after vax; BP 100/60 observed x 15-20 min w/o further problems;
10 pm on 4/1 I started with fever of 101.9. Fatigue and joint and muscle pain and headache.
Received vaccine - 10:45am 4/8 Severe arm soreness - 5:45pm 4/8 Body/muscle aches - 7:00am 4/9 Chills - 7:00am 4/9 Nausea/vomiting - 7:45am 4/9
Spontaneous Occurrences of: Dysuria, Related symptoms of Myocarditis (pending diagnosis), Fatigue, Related symptoms of Guillain Barre Syndrome; Difficulty walking without any assistance; patient is a 48-year-old male who received mRNA (Moderna COVID-19 Vaccine) Lot No 026B21A) for COVID-19 Vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported.
Fever of 100.9, chills, myalgias, weakness, mild nausea, decreased appetite, headache, fatigue
Sudden onset fever approx. 6 hours after influenza dose #2 given; seizure w/fever-seen and triaged in emergency dept.
G62.9 NEUROPATHY 5/31/2022 UNINTENTIONAL WEIGHT LOSS
MULTIPLE SUBSEGMENTAL PULMONARY EMBOLI WITHOUT ACUTE COR PULMONALE ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE PULMONARY EMBOLISM HYPOXIA
Problems began one day after the vaccine, at first with sort of tolerable fatigue, headache, dizziness, and fatigue.  Symptoms increased on 3rd day's evening post-vaccine.  Pronounced hypersomnia, with up to 16 hours sleep and periods of rest/sitting in between, which lasted up to 12 days.  Fatigue above my normal level continues, but not now as severe, and sleep back to close to normal (about 10 hours).  Severe headache with marked dizziness for first 3-5 days, with these symptoms continuing at rather low level off and on now.  Elevated body temperature around 3-4am at night for first 3-4 days, with vivid dreams.  About 80% recovered.
2nd dose of Moderna COVID Vaccine administered 21 days after 1st dose to avoid wastage of expiring doses. No adverse reactions noted.
LABIAL ULCERS; This spontaneous report received from a health care professional concerned a 24 year old female. The patient's height, and weight were not reported. The patient's past medical history included Covid, and concurrent conditions included alcohol user, non smoker, and marijuana abuse, and other pre-existing medical conditions included the patient had no known drug allergy. the patient was not pregnant at time of reporting. 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 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-APR-2021, the subject experienced labial ulcers. Laboratory data included: Herpes virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from labial ulcers. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Hives on 1 hand (palm) and both feet hives and burning (evening of #3 HBV). History per pt: Had hives beginning in July but could not remember if before or after 1st Hep-B or 2nd Hep-B; has had "hives" at all intervals since 8/00; resolved 1 week prior to #3 Hep-B. Has been seen by dermatologist but did not relate that she had had 2 HBV's. Was advised to take Benadryl but chose to use Claritin.
Patient received second dose of Pfizer vaccine on 02/26/21. Starting having a fever from 02/27 and shortness of breath from 02/28.
Initial information received on 26-Jul-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case is linked with 2018SA207851, 2018SA208858, and 2018SA208862 (same reporter). This case involves a 12 months 6 days old patient (unknown gender) who was vaccinated with an expired vaccine ACT-HIB VACCINE lot UI719AAA, (expiry date: 18-Oct-17), dose 4 in the right thigh on 13-Feb-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE for Immunisation; PREVNAR 13; and VARICELLA ZOSTER VACCINE. It was a case of actual medication error due to expired vaccine used and inappropriate schedule of vaccine administered. It was unknown whether patient experienced any adverse event to product. 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. Documents held by sender: None
30 seconds after GARDASIL vaccine was administered she complained of feeling weird. While in seated position she slumped forward was unresponsive for less than 3 seconds. Then stated she had blurred vision. Felt faint, was reclined to lying position with lower extremities elevated. Became aware and responsive, she was monitored for 15 min. Left office without complications.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 4 (booster), single (Lot number: GJ6665) at the age of 39 years, in left arm 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: "Eosinophilic asthma/Asthma" (unspecified if ongoing); "Gerd" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Chronic idiopathic urticaria" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Semaglutide, reaction(s): "Known allergies: Semaglutide"; Linagliptin, reaction(s): "Known allergies: Linagliptin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 23Aug2023 to 28Aug2023.; Sender's Comments: The efficacy of a vaccine varies individually and can be affected by different factors including product potency; however, a contributory role of BNT162b2, BNT162b2 omi ba.4-5  to the event drug ineffective cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300291519 Same patient, different event/drug;
Afternoon after receiving Adacel, fell asleep tired 1 hr after, woke after 3 hrs with n/a, pain in area of brachial (collar bone right neck area). HA, dizziness and pain have persisted since injection last was 6 days.
Patient developed eye symptoms (diplopia, left eyelid drooping, eye edema, redness) approximately 2 weeks after 2nd Pfizer COVID vaccine. She was seen by endocrinology and treated as Graves' eye disease. Of note, patient had a history of Graves disease in the past treated with radioactive iodine ablation. She was treated with medical therapy including high dose steroid infusions to try to treat medically, currently undergoing evaluation for possible surgical treatment of eye disease.
Starting 1 week after receiving the vaccine, I started to have trouble breathing. It wasn't until one week later that I went to the ER. They tested me and determined it was asthma (the first time I had been treated for asthma). They gave me oxygen to help me breath and medicine to take everyday and a medicine to take as needed. I take the medicine every day and haven't needed the as needed medicine. If I stop taking the medicine daily, I'll feel poorly.
patient came to pharmacy with her left arm swollen in several places below  the injection site in a non-uniform manner.  her arm was warm to the touch and she complained that it "felt weird".  the pain was up to her neck and down to past her elbow.  the swelling was in lumps.  she said her arm started to hurt the evening of getting her shot and continued to ache.  We had told her she should get that looked at by a physician.  I spoke with the  patient after she went to see a doctor.  they told her to take benadryl and ice the area down stating it was an allergic rxn.
Vomiting all intake. Listless, Lethargic, Pale. Dehydrated. Finally a bloody diaper.  02/05/2008 Vax record recd from PCP and TC with PCP.  Date of only Rotavirus vax given noted as 7/9/1999.  WCC (2 month) on 7/9/1999 with normal exam except scaly seborrhea noted. WCC 8/31/99 with normal exam. OV 9/20/99 with c/o vomiting all day. PE (+) for Lethargy, depressed fontanelle, and a LLQ mass felt.  Sent for admission to hospital with Assessment: AGE, ? malrotation, ? volvulus.  F/U 9/23/99-child admitted with currant jelly stools.  DX Intussusception.  Reduced by Barium enema. 02/19/2008 MR received for DOS 9/20-21/1999 with D/C DX:  Intussusception. Infant presented and treated as above.   D/C home next day
Pt woke up this AM noticed 4 red spots at the site of injection.  Itchy and red.
Intense ache started at 2 am behind left knee.  Noticed noticeable inflammation   in left leg.  Did not have usual utility of leg. Hurt to kneel down and bend leg.      Inflammation above knee very apparent.   First few days had throbbing pain if standing too long.   Leg felt stiff at hip joint, if stressed or walking too long.     Still have symptoms  as of Feb 1st,..............
A 34 year old male received his 3rd dose of Anthrax vaccine on an unknown date. The pt experienced mild tenderness at the injection site with the 1st dose and was diaphoretic, weak and pale with the 2nd dose. On an unknown date, 20 hours, post vax of this 3rd injection of Anthrax, the pt was transported to the ER via paramedics. The pt was administered oxygen 100% via facemask en route to the ER and hydrocortisone 100mg and diphenhydramine 25mg were given IV. He way dyspneic, diaphoretic and pale with urticarial wheals on his face, arms and torso. On arrival, the pt's blood pressure was 124/68 mm Hg, heart rate 48 bpm in a sinus rhythm, respiratory rate 16/min and oral temperature was 96.5F. On exam, the pt's neck was supple, lung auscultation was noted to be clear and the abdomen soft. As his respiratory status improved, the pt was changed to oxygen at 2 L/min via nasal cannula, maintaining oxygen saturations of 98% via pulse oximeter. Within 2 hours, the symptoms resolved and the pt was discharged on prednisone 10mg TID for 2 days, 10mg BID for 2 days and then 10mg daily for 2 days. He was also advised to take diphenhydramine 25mg 1 to 3 times daily, as needed. Follow-up conducted several days later, revealed that the pt developed no additional problems.
ADMINISTERED PFIZER 5-11YRS FORMULATION WITHOUT DILUTING PRIOR TO INJECTING.
Developed temp, worsened cough- has cough at baseline r/t asthma/copd- tested positve for covid on binax rapid antigen test. Fully vaccinated w/ Moderna- no booster dose.
3 episodes of Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced shingles. The patient was treated with medication unknown (Topical Cream). On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The patient received his first dose of Shingrix in unknown arm, no lot number or expiration date was known.  Since then, he had 3 episodes of Shingles.  He was treated by his healthcare professional with medication and topical cream.  He asked if he should get the second dose of vaccine.  The reporter was provided medical disclaimer and referred to healthcare professional.  The reporter was offered number to Medical Information for healthcare professional to follow up. The reporter did not consent to follow up and declined to provide healthcare professional contact information. The case US2021AMR240066, US2021AMR240065 were deleted and all the information were merged in US2021239183 in one cases because different episodes from the same adverse event occurred after the same dose administered. Note: Same preferred term was kept only once.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR240065:Same reporter. US-GLAXOSMITHKLINE-US2021AMR240066:Same reporter.
Right arm is swelling to twice the normal size, painful to the touch, unable to move the arm to drive or do work and patient had to call out sick. The symptoms were highest in intensity on 9/9/20 after going home after receiving shot, and swelling/pain has gone down a little bit today (9/10/20) AM. Advised to take some OTC antihistamine to reduce the swelling and OTC analgesics to help with pain
Pt was given Varicella vaccine to the left deltoid. It was suppose to be given subcutaneous. 3-4 minutes feeling dizzy, lightheaded around 10:45 am on 10/17/16.
Case completed primary Covid series in October 20212, then was hospitalized for Covid in March  2022.  Medical record review indicates case was symptomatic for Covid (fever, cough, headache, SOB, diarrhea, loss of appetite), along with GI bleed, and respiratory symptoms which improved with diuresis. Other treatments contraindicated due to other health issues.
Hives, swelling, pain at injection site eight days after injection;  started taking Benadryl; went on to get hives on body 24 hours later then started with severe migraines; was sick for five days.  Six days later I noticed a blind spot in my left eye field of vision which was diagnosed to be  Optic Neuritis for which I have been hospitalized and treated for and have been very ill since.
A week after receiving the vaccine, I developed COVID Arm, and had a red rash that covered from the injection site down my left arm.