chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lacked apetite; weak all day; body aches; chills; hot sweats; light sensitivity; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPHOBIA (light sensitivity), DECREASED APPETITE (lacked apetite), HYPERHIDROSIS (hot sweats), ASTHENIA (weak all day) and MYALGIA (body aches) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergic to Codeine), Blood pressure high since 2005, Vitreous floaters and Ocular Migraine (occurs less than twice a year) since 2008. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) for Blood pressure high, WOMENS MULTI ONE A DAY for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced PHOTOPHOBIA (light sensitivity), HYPERHIDROSIS (hot sweats), MYALGIA (body aches) and CHILLS (chills). On 05-May-2021, the patient experienced DECREASED APPETITE (lacked apetite) and ASTHENIA (weak all day). On 05-May-2021, PHOTOPHOBIA (light sensitivity) had resolved. On 06-May-2021, DECREASED APPETITE (lacked apetite), HYPERHIDROSIS (hot sweats), ASTHENIA (weak all day), MYALGIA (body aches) and CHILLS (chills) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was reported.   This case was linked to MOD-2021-068491 (Patient Link).
Post-Vaccination the Pt Fainted and hit her head on floor in front of the pharmacy.  Pt reacted w/ convulsions consistent of a possible mild concussion. Pt was alert and oriented to time and place and pupils were round and reactive to light.  Pt had a consistent pulse and was breathing normally.
Chronic Idiopathic Urticaria and angioedema (all areas of the body) most days starting approximately 24 hours after second vaccine.  No history of urticaria or angioedema, no allergies. Similar presentation 4 days after first vaccine but ceased after 10 days without medication. Unlike after the first vaccine, symptoms did not stop after second vaccine. Patient self-medicated with diphenhydramine. Patient saw allergy specialist doctor 21 May 2021 who prescribed prophylactic fexofenadine for two weeks, then patient to test if symptoms recurred. After approximately 2 months, patient was able to stop taking fexofenadine without symptoms recurring. As of 16 August, symptoms do recur but only very occasionally.
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O15821a) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Unspecified drug.). Concomitant products included LORAZEPAM, DULOXETINE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from an unknown date to 24-May-2022 and ZOLPIDEM from an unknown date to 24-May-2022 for an unknown indication.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 24-May-2022 to 29-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.            On 02-JUN-2022 at 11:00, the patient had COVID rebound and at the time of reporting it was reported as not recovered.  Device date was reported as 02-Jun-2022.  Company comment- This spontaneous case concerns a 54-year-old female patient with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 which occurred at an unknown time with regards to the mRNA-1273 vaccination. The patient experienced Covid rebound 4 days after completing the course of paxovid. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 54-year-old female patient with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 which occurred at an unknown time with regards to the mRNA-1273 vaccination. The patient experienced Covid rebound 4 days after completing the course of paxovid. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
LARGE PLAQUE KNEE; LOST ALL OF HAIR; BAD ARM PAIN FROM THE COVID BOOSTER SHOT; This spontaneous case was reported by a consumer and describes the occurrence of SKIN PLAQUE (LARGE PLAQUE KNEE), ALOPECIA (LOST ALL OF HAIR) and VACCINATION SITE PAIN (BAD ARM PAIN FROM THE COVID BOOSTER SHOT) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. In November 2021, the patient experienced VACCINATION SITE PAIN (BAD ARM PAIN FROM THE COVID BOOSTER SHOT). On an unknown date, the patient experienced SKIN PLAQUE (LARGE PLAQUE KNEE) and ALOPECIA (LOST ALL OF HAIR). At the time of the report, SKIN PLAQUE (LARGE PLAQUE KNEE) was resolving, ALOPECIA (LOST ALL OF HAIR) had not resolved and VACCINATION SITE PAIN (BAD ARM PAIN FROM THE COVID BOOSTER SHOT) outcome was unknown.            No concomitant medication was reported. No treatment information was provided.  The patient had one big plaque on knee, but still so much better everywhere else, now on other parts of body. Scalp used to be horrible. Patient lost all of hair prior and had not really grown back. Per physician, if it grows back it would likely take a year. Patient also had really bad arm pain from the COVID booster shot.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event of large plaque knee with Skyrizi (risankizumab) was a reasonable possibility (or probable). The reporter's causality for the event of lost all of hair and bad arm pain from the COVID booster shot was not provided.
17-year-old pregnant female vaccinated on 1/3/2022 and 2/3/2022 with Moderna COVID-19 vaccine instead of Pfizer. Teenage parent in third trimester. Due on 4/12/2022. At visit on 2/17/2022, measured 29 cm without growth since last visit in previously normal pregnancy. US scheduled for follow-up.
Patient has rash and redness on the arm she was given the shot at which is hot to touch. Patient also complains she doesn't feel good.
identified visual disturbance in the right eye consisting of flashing lights; identified visual disturbance in the right eye consisting of flashing lights; This is a spontaneous report from a contactable consumer, the patient and from a contactable consumer. A 66-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration on 30Sep2021 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. It was unknown whether the patient had any known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received other medication within two weeks of vaccination was reported as uncertain. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Oct2021 at 08:00, the patient experienced identified visual disturbance in the right eye consisting of flashing lights. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events identified visual disturbance in the right eye consisting of flashing lights was unknown at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
PATIENT HAD VASO SYNCOPE. HE HAD TINKLE IN LEFT HAND. HE WAS ASKED TO SIT FOR 30 MINUTES VS. 15 MINUTES FOR EXTRA OBSERVATION. HE SAID HE WAS FEELING LIGHT HEADED AND SWEATING.  AS I WAS WALKING OVER FOR THE 3RD TIME TO CHECK ON HIM I WAS GOING TO ASK HIM TO PUT HIS HEAD IN BETWEEN HIS LEGS HE STARTED TO SLIDE OUT OF CHAIR. WE CALLED 911. WHEN HE CAME TO HE SAID HE PASSES OUT EVERY TIME BLOOD IS TAKEN, AND HE THINKS IT WAS DUE TO THIS ANXIETY.
Headache Narrative:  dizziness, metallic taste, fatigue, pain LUE, swollen lymph, anterior axilla soft and tender, sore left breast
CHEST HAS BEEN VERY TIGHT; WORKED UP; STROKE; This spontaneous report received from a consumer via social media concerned a 25 year old of unspecified sex, race and ethnicity (local case ID# 003264333). The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administrated for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 26-SEP-2021, the patient experienced stroke. On an unspecified date, the patient experienced chest has been very tight, and worked up about it and the patient thought that something was wrong. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest has been very tight, worked up and stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210956447-covid-19 vaccine ad26.cov2.s- stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Lightheaded and nausea w/in 1 hour of vaccine. Con't over rest of day and next (Wed and Thur.). Woke up Fri AM room spinning, ate toast in bed. When got up vomited. Nausea, room spinning, vomit all day. To ER in early evening, admitted x 3 days. Neg CT scan. Nml blood work. MD suspects vaccine got into ear canals. Tx = MECLAZINE, bed rest. 11/9/2009 hospital records for 10/23-10/26/2009. Patient with c/o's vertigo, nausea and vomiting. Tx: IVF, IV zofran. DC DX: Vertigo, nausea/vomiting. Dc'd home on Zofran and meclizine. ICD-9 codes 780.4, 787.01
No previous history of Miscarriage, one successful pregnancy. The estimated date of delivery was November 3rd, 2021. Miscarried 1 week after first covid vaccine. Ultrasound with strong heartbeat completed 4 days prior to Moderna vaccine.
Doses were given one week apart; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Doses were given one week apart) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Doses were given one week apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Doses were given one week apart) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant drugs are provided, and no medicines apart from suspect drug was not provided   Reporter did not allow further contact
About 10 minutes after getting vaccinated, patient felt dizzy. We let him lay down on the floor and monitored his blood pressure. His blood Pressure (average of 2 readings) was 119/85, pulse 86. Patient felt ok after 5 minutes. We observed him for extra 5 minutes before he left the clinic feeling well, without any symptoms of dizziness.
About 15 minutes after vaccination, patient began to experience lightheadedness and numbness, tingling and itching to her face.  Vital signs showed tachycardia, but otherwise normal.  Taken to ED and noted with rash to chest and neck.  Given Benadryl 50 mg IV, famotidine 20 mg IV and solumedrol 125 mg IV in ED.  The rash and lightheadedness resolved.  Home with Benadryl 25 mg PO TID PRN, prednisone 60 mg daily x 3 days and famotidine 40 mg PO at HS.
Initial unsolicited report received from an other non-health professional on 11- Jan-2018. This case was linked with 2018SA012740. This case involves a patient of unknown age and gender, who was vaccinated with 0.5 ml dose of ADACEL once via intramuscular route (Batch number: U5879AB, expiration date: 13-Mar-2020, dose in series and site of administration were not reported) on an unknown date (reported as 01/17). Patient's medical history and concomitant medications were not reported. On an unknown day (reported as 1/17), following the vaccination, the patient had flu like symptoms. Laboratory investigations and corrective treatment were not reported. The outcome of the event was unknown. Documents held by sender: none
received pentacel vaccine and IPOL vaccine with no reported adverse event; Initial information received on 05-Aug-2022 regarding an unsolicited valid non-serious case received from health professional. (GMI Inquiry Number: 01223818)   This case involves a 2-year-old female patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] vaccine and IPV (VERO) [IPOL] vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis B vaccine for Immunization.  On 26-Jul-2022, the patient received suspect IPV (VERO) at dose 0.5 ml once (lot number not reported via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient received suspect Pentacel Vaccine (unknown formulation, strength, dose, lot number, route in unknown administration site) for prophylactic vaccination.  Information regarding batch and expiry date requested.  On 26-JUL-2022 the patient received Pentacel vaccine and ipol vaccine with no reported adverse event (contraindicated product administered) same day latency.  Action taken: Not applicable for both suspects.  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 guidelines. 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.
This is day 7 since the vaccine and "I'm" still getting a fever daily.; "I" have been sick every single day since the vaccine; "I'm" also still having headaches; Joint pain; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 28-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0164) via an unspecified route of administration in the left arm on 16Apr2021 at 10:00 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 16Apr2021 at 12:00, the patient experienced fever, sick, headache and joint pain. The patient reported that "this was day 7 since vaccination and she still getting fever daily, she has been sick every single day since the vaccine and also getting headaches and joint pain". The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient has been tested for COVID-19. On 22Apr2021, the patient underwent COVID-19 test via nasal swab and the result was found to be negative. The clinical outcome of the events fever, sick, headache and joint pain were not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
No adverse event has occurred.  Moderna vaccine was given to a 17 year old person as a booster, one week prior to being 6 months from second dose of Pfizer.
I experienced a fever, headache, and body aches on the day after the vaccine and reported them. Now today, four days after the vaccine I woke up with dizziness and blurred vision. I have not sought out  treatment for this.
4cm area of localized swelling and induration over left upper arm at injection site. Tx: Ice, ASA prn RTC prn.
tested positive today for Covid 19; tested positive today for Covid 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 36-year-old female patient received BNT162b2 (COMIRNATY), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Jun2022, outcome "unknown" and all described as "tested positive today for Covid 19". The patient underwent the following laboratory tests and procedures: Body temperature: (15Jun2022) low grade; SARS-CoV-2 test: (15Jun2022) Positive, notes: tested positive today for Covid 19.  Clinical information: I am writing to report that my spouse, a 36 year old female, tested positive today for Covid 19 after having had 2 PFE comirnaty shots, and a PFE comirnaty booster. Her symptoms include tight chest, sore throat, low grade fever and fatigue.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Severe pain in L deltoid and up L neck and very tired. Some mild bruising in area of shot. No sign of hematoma.
Pt has a history of CAD, severe COPD with asthma (on 3L home oxygen), ischemic cardiomyopathy, and stage III CKD, presents with one week of diarrhea and worsening shortness of breath.  Found to be COVID positive.
This spontaneous report was received from an office manager and refers to a 12 month-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 04-NOV-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with an expiration date on 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. No data logger was involved. This is one of several reports from the same source. Additional information has been requested.
Pt. experienced syncopy post the administration of Moderna vaccine at 13:15 hours - At approximately 13:30 hours, episode was reported.  B/P 98/63 - Pulse 80 - Felt better lying down - EMS called post assessment by Dr.  Repeat B/P by EMS was 120/XX Transported Ambulance.
induration +cellulitus starting on 4/28/04. Fever 101. Duracef 250 mg/5ml with tsp qdx 10 days. Cold compress
Adverse events I?m all pissed off. cramps all over my body legs arms hands both sides of my rib cage neck I?m sick  fatigued the runs just yesterday and Today
injection site pain muscle pain joint pain fever injection site swelling injection site redness nausea swollen lymph nodes  These adverse events occurred from January 5th until January 9th.  Tylenol was used to reduce fever and pain.
Had me wait for 15 minutes after vaccine and started having a redness in neck and was really itchy; whole body big time itchy. My chest - shortness of breath. Gave me a shot of benydryl  - 25 mg in my right arm and I went home and itching still didn't go away and I took pill of benydryl. Chills next day; super cold; headache; tired - and I couldn't think straight. Nothing was registering in my head with training at work - felt slow. Went home from took more benydryl. Next morning - pins and needles in back of my head. Went to urgent care (Riverside Urgent Care) and they gave me gave me Vexamethasone - shot it up in my butt and every symptom went away after that shot and I was okay after that.Itching went away after that. Felt weak for about a week afterwards. Went and had second shot yesterday 1/10/2021. They gave me medication with vaccine so I wouldn't get reaction this time. Gave me liquid 25 benydryl beforehand and had me wait 15 mintues and after 15 min they gave me the second dose of vaccine after the injection and they had me wait for 30 minutes. Right away I started getting itchy and they gave me pill form( 2 pills) of Vexamethsone and itching slowly stopped and they sent me home after an hour. Itching slowly went away - later that day. And today I'm okay.
Immediately upon the administration of the vaccine she stood up walked a few feet to a chair sat down and had a gradual onset of a tightness sensation in her forehead followed by a mild headache which she described as dull in nature.  The headache resolved at approximately 45 min later.  She took her blood pressure at the facility and found it to be 200/80 she was advised to go to the emergency room for evaluation.  The patient states that she had a similar situation approximately 6 months ago which also gave her some mild left facial paresthesia.  She received a full work-up and she was prescribed Coreg 3.125 mg and was advised to take it twice a day but did not initiate.