chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Not able to taste Gatorade; Reduced smell; Severe body aches; Chills; Nausea; Hot flashes without fever; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot flashes without fever), AGEUSIA (Not able to taste Gatorade), HYPOSMIA (Reduced smell), MYALGIA (Severe body aches) and CHILLS (Chills) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced HOT FLUSH (Hot flashes without fever), MYALGIA (Severe body aches), CHILLS (Chills) and NAUSEA (Nausea). On 30-Apr-2021, the patient experienced AGEUSIA (Not able to taste Gatorade) and HYPOSMIA (Reduced smell). At the time of the report, HOT FLUSH (Hot flashes without fever), AGEUSIA (Not able to taste Gatorade), HYPOSMIA (Reduced smell), MYALGIA (Severe body aches), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.            Concomitant medication were not reported.  Treatment medications were not reported
Information has been received from a pharmacist referring to an 81 year old male patient. The patient had no drug reaction or allergies. Concomitant medication included SYNTHROID, furosemide (manufacturer unknown), carvedilol, fluorouracil cream, simvastatin (manufacturer unknown), dutasteride, sotalol, hydralazine and isosorbide. On 20-JUL-2016 the patient was vaccinated with ZOSTAVAX (0.65 ml, once, subcutaneous in the left arm, lot # M010472, expiration date 01-JUN-2017). On an unknown date in July 2016 the patient developed shingles on his abdomen. The patient saw his physician on 27-JUL-2016 and was prescribed prednisone (manufacturer unknown) and VALTREX. No lab diagnostics studies were performed. The patient had not recovered from the event. Additional information has been requested.
FLU LIKE SYMPTOMS (FEVER, BODY ACHE, CHILLS); This spontaneous report received from a patient via a company representative concerned a 65 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included Crohn's disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced flu like symptoms (fever, body ache, chills). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu like symptoms (fever, body ache, chills) was not reported. This report was non-serious.
w/in mins of vax pt reports devel chest & arm pain along w/some SOB;p/several hrs pt called nurse who referred her to PMD or ER suspecting poss adverse or allerg rxn;pt seen by MD who advised that vax inj close to nerve;muscle sore
Tachycardia (HR 130 when sitting, typical resting 64), abnormal menstrual bleeding when periods are not present, light headedness/dizziness, low grade fever (99.9F oral), chills, sweating, foggy headed feeling, body aches.
This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (Rancid smell), ABNORMAL FECES (Vile odor stool) and HAIR GROWTH ABNORMAL (Hair stopped growing) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 035C21A) for COVID-19 vaccination. Concurrent medical conditions included Heartburn. Concomitant products included ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for Heartburn, ASPIRIN [ACETYLSALICYLIC ACID], CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]), HYDROCHLOROTHIAZIDE, SIMVASTATIN, METOPROLOL, VITAMINS NOS, FISH OIL, VITAMIN D NOS and PROBIOTICS NOS for an unknown indication. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced PAROSMIA (Rancid smell), ABNORMAL FAECES (Vile odor stool) and HAIR GROWTH ABNORMAL (Hair stopped growing). At the time of the report, PAROSMIA (Rancid smell), ABNORMAL FAECES (Vile odor stool) and HAIR GROWTH ABNORMAL (Hair stopped growing) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.
On 5/3/21 at 1p, patient received her 2nd Covid vaccine (Pfizer).  First dose was administered on 4/12/21 at 1p.  On 5/5/21, patient noticed a rash on her right fore arm and right chest.  Over the next few days, more rash appeared along her right arm.  Diagnosis: Shingles along T1
feel extremely cold and very chilly, and could not get warm no matter what they did; arm hurt and it is still sore today; their back bothers them, and they feel like they have been punch on the stomach and back; their arm is stiff; very chilly; Achy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feel extremely cold and very chilly, and could not get warm no matter what they did), PAIN IN EXTREMITY (arm hurt and it is still sore today), BACK PAIN (their back bothers them, and they feel like they have been punch on the stomach and back), MUSCULOSKELETAL STIFFNESS (their arm is stiff) and CHILLS (very chilly) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Feb-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021 at 10:00 PM, the patient experienced FEELING COLD (feel extremely cold and very chilly, and could not get warm no matter what they did), PAIN IN EXTREMITY (arm hurt and it is still sore today), BACK PAIN (their back bothers them, and they feel like they have been punch on the stomach and back), MUSCULOSKELETAL STIFFNESS (their arm is stiff), CHILLS (very chilly) and MYALGIA (Achy). At the time of the report, FEELING COLD (feel extremely cold and very chilly, and could not get warm no matter what they did), PAIN IN EXTREMITY (arm hurt and it is still sore today), BACK PAIN (their back bothers them, and they feel like they have been punch on the stomach and back) and CHILLS (very chilly) had resolved and MUSCULOSKELETAL STIFFNESS (their arm is stiff) and MYALGIA (Achy) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not provided. In the morning of the report, most of the side effects went away but still had aches and arm was stiff.   This case was linked to INC.-MOD-2021-090221 (E2B Linked Report).; Sender's Comments:  INC.-MOD-2021-090221:dose 2
Shot administered at top of shoulder. More painful during administration than normal. Pain continued to get worse. It became difficult to take off a shirt or put on deodorant. Returned to pharmacy on 11/13/2018 to talk to the pharmacist about the pain. They dismissed any issue and suggested ibuprofen. Started taking max daily dose of ibuprofen and pain continued to worsen. Called PCP on 12/12/2018. Doctor was on vacation until after the holidays. Called specialist on 12/13/2018 and was seen on 12/18/2018. Also had imaging (MRI, x-rays) on 12/18/2018. Was diagnosed with impingement syndrome and early frozen shoulder and given two cortisone shots during the same appointment. Was ordered to continue ibuprofen and begin physical therapy. Saw no improvement after 3 weeks and was given another round of cortisone shots. Was given another 3 weeks to improve and then surgery was recommended. Subacromial decompression surgery occurred on 3/25/2019. Recovery is ongoing.
10 days after my Moderna booster my body began to itch throughout the day and by 6pm I started to break out in hives along my right side under my armpit and down along my rib cage. This continued for six days along with serious body pains from inflammation, I am currently on day 33 and still super itching and hives at night time but dermatographia throughout the day. I?ve been treating with Zyrtec and Benadryl as recommended from a doctor on a  call where he confirmed the hives but did not want to refer me to an allergist unless I began to go into anaphylaxis.
Pt initally complained of a headache. Pt has history of migraines. Pt was assisted to first aid station where she laid supine on the cot. Over the next 30 min's pts increasingly became short of breath. SAT's were 90-93% on room air. Pt was placed on simple face mask at 6L/min. SAT's rose to >95%  Pt used personal rescue inhaler to no avail.  Pt complaining of difficulty swallowing and  chest tightness, SOB, and dizziness. First does of Epinephrine 0.3mg IM was administered. Pt was continually assessed. After 10min pt still complaining of same signs and symptoms. Second does of Epinephrine 0.3 mg IM was administered. Signs and Symptoms still persisted. At this time EMS was activated and pt was transported to the hospital awake, alert, and oriented.  Vital signs checked every 15 minutes.
Rash NOT at injection site; began 9 days following injection.  Began on shoulder blade, traveled across chest, back, legs, and buttocks.  Red and inflamed, felt like a sunburn.  Lasted approximately 3 days.  Site of FIRST INJECTION on OPPOSITE arm also developed a rash for a short period of time.    This was following SECOND vaccine.  I developed "Moderna arm" after the first injection, but it followed the traditional trajectory of a rash at the injection site.
Progressive pain and stiffness in left arm. Pain localized around shot area and radiating down arm. Muscle weakness, pain and circulation affected. Unable to raise arm above chest level. Also, a webbed mottling pattern under the skin on bicep still present after two months. The symptoms were reported to the Employee Health Dept who continues to state take 400mg of Motrin and do some exercise for the arm. Give it about two months.  This time has now expired and no improvement has been made.
Side effect after first shot: Unable to lift arm pass elbow height 2½ days after injection.   Side effects after second shot: Chills 101 Fever Joint pain in elbows, hands, back Headaches Unable to lift arm pass elbow height 2-3 days after injection Itchiness on injection site.
Itchy (rash); rash allover the body; This spontaneous case was reported by a consumer and describes the occurrence of   in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form; HYDROCORTISONE ongoing since an unknown date at a dose of 1 dosage form and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant was provided. Patient was treated with Ant-itchy cream.
Patient took pain medication in between doses; This is a spontaneous report received from a Pfizer sponsored program Covax Support from a contactable consumer (the patient, reported for herself). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not reported), via an unspecified route of administration on 13Mar2021 as single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included tapentadol hydrochloride (NUCYNTA) for pain. Patient wanted to check if she could take the pain medication (tapentadol hydrochloride (NUCYNTA)). Patient was taking before having the 2nd dose. Patient took pain medication in between doses. Patient had the first dose on 13Mar2021, and the 2nd dose is scheduled on 05Apr2021. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  No follow-up attempts are needed. No further information is expected.
Extreme muscle weakness/ache, chills and shaking. Began around 11pm on 1/19/21 and mostly cleared by 3pm on 1/20/21. Was severe enough to prevent working, paid or otherwise.
she has developed chills; her fingers were turning blue.; her fingers were turning blue.; This is a spontaneous report from a contactable consumer and from a Pfizer sponsored program COVAX US support. This 76-year-old (age at vaccination) female consumer (patient) reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number; EN6207, expiration date; 31Jul2021, Pfizer COVID 19 vaccine manufacturer; Unspecified, NDC number; unknown) via an unspecified route of administration on 17Mar2021 at 10:30 at left arm as dose 2, single for covid-19 immunisation. Vaccination facility was Health and Wellness Center. Patient's medical history included blood pressure high, high cholesterol, knee replacement from Jul2020 to unspecified, heart problems, breast cancer (dates unspecified). Patient mentions predating treatment with the Pfizer COVID 19 vaccine, she had knee replacement surgery in Jul2020 and Nov2020 and had a COVID 19 test done before each time. Both the COVID 19 test from Jul2020 and Nov2020 were negative. Family History included mother heart problems; sister breast cancer; daughter breast cancer; father cancer. Relevant tests included two COVID-19 tests both negative on Jul2020 and Nov2020. Historical vaccine included first dose of BNT162B2, lot number: EN6199, on 24Feb2021 at 10:30 am in left arm for covid-19 immunisation. Concomitant medications were not reported. Prior vaccinations (within 4 weeks) were reported as none. Consumer had the first dose of the Pfizer COVID-19 vaccine on 24Feb2021 and had no reaction after. Consumer got the second dose on 17Mar2021. On 24Mar2021, she has developed chills and her fingers were turning blue on 24Mar2021 to ongoing. Reporter seriousness for the events was unspecified. The AEs did not require a visit to emergency room or physician's office. Consumer wanted to know if that is an adverse events associated with the vaccine and if those are adverse events that would go away. She also would want to know if she should go to the ER for it. Consumer states she has received both of the vaccines. Last week on 17Mar2021 she got the second dose. Then on 24Mar2021 she noticed chills; and her hands and fingers turned blue. They are still that way today. She didn't know if she should call Pfizer or call the wellness center. She is asking if this will go away or should she go to the ER? Clarifies she received the first dose of the Pfizer COVID 19 vaccine on 24Feb2021 at 1030 am in the left arm and had no reaction. Then she had the second dose on 17Mar2021 at 1030 am in the left arm. Patient does not see NDC on her vaccination card. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Given DTaP, IPV left arm on 5/3/04. Developed warmth, erythema by 5/5/04. Diagnosed cellulitis vs 122 rxn. Received Keflex x 10 days
Patient received 0.2 ml of undiluted dose of 5-11 yr old Pfizer vaccine.
Dr wants to find out if VAXELIS can be given to a 5 year old pt,Physician reported child was ordered by another practitioner in the office to receive VAXELIS as part of catchup schedule,Sending due to off-label use as part of catchup schedule; Dr wants to find out if VAXELIS can be given to a 5 year old pt,Physician reported child was ordered by another practitioner in the office to receive VAXELIS as part of catchup schedule,Sending due to off-label use as part of catchup schedule; This non-serious spontaneous safety report with reference number #2023SA238033 (Inquiry #01714708) was received by a partner on 02-AUG-2023 and forwarded on 04-AUG-2023 from a health care professional.  This case was considered non-valid due to the lack of patient identifiers.   Due to the nature of the events, the causality between the events "Dr wants to find out if VAXELIS can be given to a 5 year old pt, Physician reported child was ordered by another practitioner in the office to receive VAXELIS as part of catchup schedule, Sending due to off-label use as part of catchup schedule" and Vaxelis was not applicable.  Further information is expected.  Significant Follow-up information was received by the partner on 22-AUG-2023 and forwarded on the same day, from a physician. This case is maintained as non-serious.  This case was considered off-label due to use in unapproved age group.   Due to the nature of the events, the causality between the events "Dr wants to find out if VAXELIS can be given to a 5-year-old pt, Physician reported child was ordered by another practitioner in the office to receive VAXELIS as part of catchup schedule, Off label use in unapproved age group" and Vaxelis was not applicable.  Further information is expected.   Duplicate information was received by the partner on 25-AUG-2023 and forwarded on 25-AUG-2023, from a physician. This case is maintained as non-serious.  This case was considered off-label due to use in unapproved age group.   Due to the nature of the events, the causality between the events "Dr wants to find out if VAXELIS can be given to a 5-year-old pt, Physician reported child was ordered by another practitioner in the office to receive VAXELIS as part of catchup schedule, Off label use in unapproved age group" and Vaxelis was not applicable.  Further information is not expected.
Pt. saying she has a humming and whooshing sound in left ear. Started after receiving flu vaccine. Started day after.
My daugther complained about her knees feeling weak and wanting to give out from under her and that there was a tingling feeling.
This spontaneous report as received from a female nurse of unknown age referring to herself. On an unknown date, the patient was vaccinated with a 3 dose series of RECOMBIVAX HB (lot #, expiration date and route not reported) for prophylaxis. On an unknown date, the patient's titers were negative, and she competed another 3 dose series of RECOMBIVAX HB. The outcome of hepatitis b antibody negative was unknown. Causality assessment was not provided. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA012259.
The pt experienced localized cellulitis to the left thigh. Treated with children's Motrin and advised to follow up the following day.
Pt was received Dtap when they should have received Tdap. The Dtap the pt received was also expired by three days. There was no adverse affects with the patient. I was informed to fill this form out. The date of injection was 1/29/2020. Pt came back in for updated immunization.
At the time of vaccination, the area of injection started to bleed and because swollen. Later that evening the patient said that the swelling went down but that she lost feeling in her right arm. When she came to see me the following day, the site of injection was normal with no signs of a reaction (all swelling was gone) but patient said that she could barely move her arm and that it was very sore.
arm started hurting; had a bad reaction; its getting worse all the time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer: Unknown, Dose 1), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm started hurting"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "had a bad reaction"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "its getting worse all the time".  Additional information: Reporter stated "about 6 weeks ago patient went to get the second covid shot and patient had a bad reaction patient still having a bad reaction. As soon as patient got the shot patient arm started hurting and it has not quit and its getting worse all the time."   Follow-up attempts completed. No further information is expected.
Severe pain, bruising and swelling at injection site.  Severe debilitating muscle spasms and inflamation on left side of back and around to the front side of ribcage under the breast - same side as injection side.  Moderate annemia like symptons for approximately 2.5 weeks. Left neck lymphnode swelling.  Currently, still experiencing pain in arm, left side inflamation and low energy levels. Prior to vaccine I felt very healthy, but since vaccine my body just does not feel as healthy.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, the patient was treated at a medical center for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
pt awoke w/temp of 103ax, flushed, diaphoretic & jerking of upper & lower extremities;no eye rolling, no incontinence, no resp distress;short duration;
Acute onset on 10/25/22 of facial lesions (erythematous maculae). This later evolved into diffuse erythematous annular rash confirmed to be acute cutaneous lupus erythematosus.  Patient received Dermatology consultation confirming the rash following observation.  Initial skin biopsy was non-specific.  However, by Jan 2023, lab tests aligned with systemic lupus erythematosus, prompting Rheumatology consultation at local Hospital Medical Center.
pt recv vax 30JUN98 & called MD 2JUL98 c/o arm red swollen & hot in area of vaccine;pt instructed to use hot/cold packs for pain/swelling;pt told to come to office;pt called back & cancelled appt;
Headache, Myalgia, Arthralgia, Fever & CoughWheeze  Narrative: Employee developed Fever (did not check with thermometer), chills, sweats, headache, myalgias, malaise, and cough which started after her 2nd dose of vaccine yesterday. She reports that her symptoms worsened overnight. She  reports that she still feels bad but that symptoms are improving.