chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itchy area; feverish area; large pink area; itch; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), RASH PRURITIC (itchy area), PRURITUS (itch), PYREXIA (feverish area) and RASH (large pink area) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 010A21A) for COVID-19 vaccination.     No medical history provided.    On 27-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) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (sore arm). On 31-Mar-2021, the patient experienced PRURITUS (itch). On 01-Apr-2021, the patient experienced RASH PRURITIC (itchy area). 01-Apr-2021, the patient experienced PYREXIA (feverish area) and RASH (large pink area). On 30-Mar-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, RASH PRURITIC (itchy area), PRURITUS (itch), PYREXIA (feverish area) and RASH (large pink area) outcome was unknown.
Headache, fever, vomiting, slight loss of hearing in both ears, numb arm
c/o rt thigh looking like had been burned where got shot yesterday; states it wasn't like that AM, but was there p/doing yard work & moving that PM; MD called cellulitis & pt on ATB & DPH; pt had nosebleed;
None stated.  Nurse follow up on 06/25/2004: "DELETE: react uneval, ADD: cellulitis, abscess."  Nurse follow up on 06/25/04 states: "No new information."
Tachycardia; Blood Pressure was high; Started Itching; Swollen Lips; Chest was tight; Tongue Heavy; A spontaneous report was received from a 53-year-old female nurse who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed itching, lips swollen, tongue heavy, chest tightness, tachycardia and blood pressure was high.   The patient's medical history, as provided by the reporter, included asthma and high blood pressure. Products known to have been used by the patient, within two weeks prior to the event, included hydrochlorothiazide valsartan and fluticasone propionate salmeterol xinafoate.   On 12 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 12 Jan 2021 while waiting in the observation room post vaccination, the patient started itching and lips became swollen. Her tongue was heavy, and chest felt tight. She went home and the reaction started again. On 13 Jan 2021, the patient was seen in the emergency room and experienced tachycardia and high blood pressure. Treatment for the event included diphenhydramine injection and prednisone by mouth on 12 Jan 2021. On 13 Jan 2021, treatment included diphenhydramine intravenous, nebulizer treatment, famotidine, and cetirizine hydrochloride.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, developed itching, lips swollen, tongue heavy, chest tightness, tachycardia and blood pressure was high, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Generalized aching; Joint ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Generalized aching) and ARTHRALGIA (Joint ache) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 04GA21A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Tobacco user (TOBACCO USE: SIX TO SEVEN STICKS PER DAY), Abstains from alcohol, Diabetes and Hypercholesterolemia. Concomitant products included METFORMIN, ATORVASTATIN, BENAZEPRIL, RISPERIDONE (RISPERDAL) and METHOTREXATE for an unknown indication.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-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 started ADALIMUMAB (HUMIRA) (Subcutaneous) 40mg/0.4ml. On 17-Apr-2021, the patient experienced PAIN (Generalized aching) and ARTHRALGIA (Joint ache). At the time of the report, PAIN (Generalized aching) outcome was unknown and ARTHRALGIA (Joint ache) was resolving.            No treatment information was provided.    This case was linked to MOD-2021-129496 (Patient Link).   Reporter did not allow further contact
Information has been received from the authors in a letter to the editor and refers to retrospective epidemiologic assessment involving 3811 employees. The authors found a nonlinear decline in mumps seropositivity over time, with a sharp decrease 13 years after the most recent measlesmumpsrubella (MMR) vaccine dose on the basis of antibody titers obtained at the outset of employee training with the use of the BioPlex 2200 MMRV IgG multiplex flow immunoassay (Bio-Rad). Seropositivity fell below the estimated herd-immunity threshold among those last vaccinated at least 16 years earlier. Since recent mumps outbreaks have occurred in populations that had been vaccinated as children, the findings raise concern about the need for routine administration of MMR vaccine in young adults entering congregated settings, such as colleges and employee training. This case refers to 45 employees of unspecified ages and genders. The patient's concurrent conditions, medical history or concomitant medications were not reported. On unspecified dates from 1998 to 2014, 73 patients were vaccinated with two doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) as prophylaxis (dose, frequency, lot number and expiration date were not reported), from which  6 patients developed mumps on unspecified dates. 7 patients received three doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown). On unspecified dates from 2015 to 2016,  2 patients were vaccinated with one dose  of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) as prophylaxis (dose, frequency, lot number and expiration date were not reported). Both patients developed mumps on unspecified dates; 18 patients received two doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) from which 10 developed mumps on unspecified dates; 14 patients received three doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) from which 2 patients developed mumps on unspecified dates. On unspecified date in 2017, 2 patients were vaccinated with one dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) as prophylaxis (dose, frequency, lot number and expiration date were not reported); 3 patients received three doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown). And on an unspecified date, 1 patient was vaccinated with one dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown). The outcome of the event mumps was not reported.
After receiving vaccination, experienced extreme muscle soreness and fatigue. Throughout the night, chills and shaking. Severe headache and lethargy in the morning with difficulty ambulating or picking up 19 month old daughter. Then back pain over the kidneys started on that second day after the vaccine, urine began to turn dark. Increased fluids at that time, which the urine did not become dilute but more rusty colored. The third day after the vaccine (Thursday), returned to healthcare facility for a urine test. Was prescribed MACROBID. Currently pregnant with second child, due date is estimated at April 8, 2018. Current weight is 169 lbs. No previous conditions or problems up to this point. No previous history of urinary tract infections or kidney inflammatory diseases.
Slight cramping; Fluzone Quadrivalent recived by pregnant patient; miscarried; bleeding; Initial information received on 30-Oct-2019 regarding an unsolicited valid serious case received from a consumer.  This case involves a 28 years old female patient who experienced bleeding (haemorrhage), miscarried (abortion spontaneous) and slight cramping (muscle spasms), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].   Data regarding this pregnancy were received Retrospective. The date of last menstrual period was reported as 22-Sep-2019.  The estimated due date was 28-Jun-2020.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ231AA (30-Jun-2020) via intramuscular route in the right deltoid while she was pregnant.  On 28-Oct-2019, the patient developed a serious bleeding (haemorrhage) 2 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant.  On 29-Oct-2019, the patient had miscarried (abortion spontaneous) 3 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant.  On an unknown date, (Slight cramping on Sunday, then 28-OCT-2019 increased cramping) (muscle spasms) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant.  Final diagnosis was bleeding, miscarried and slight cramping.  It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for all the events.; Sender's Comments: This case involves a 28 years old female patient who experienced bleeding, miscarried and muscle spasms, while she received vaccine FLUZONE QUADRIVALENT and assessed as medically significant. The time to onset is compatible with the role of the vaccine. Moreover, patient's medical history, medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccines cannot be individually assessed.
Case number PHEH2013US025600, is an initial spontaneous report received from the pharmacist on 10 Dec 2013. This report refers to a 71-year-old female patient. Her medical history and concomitant medications was not reported. Her vaccination history included FLUVIRIN, (batch number: not reported) on an unspecified date. On an unspecified date after vaccination, she experienced shingles. The event outcome was unknown. The seriousness and causality was not reported. No additional information was available.
Intense head ache; Pain in armpit on the same side as dose; Extreme fatigue; Extremely cold; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 14Sep2021 at 15:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medication included bupropion (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the left arm on 23Aug2021 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 14Sep2021, the patient experienced intense head ache, pain in armpit on the same side as dose, extreme fatigue, all lasting for several days (as reported) and on the day of (vaccination), the patient was extremely cold. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events intense head ache, pain in armpit, extreme fatigue and extremely cold was not resolved at the time of report.  No follow-up attempts are possible. No further information is expected.
fatigue requiring sleep for >30 hours, swollen lymph nodes, myalgia, arthralgia
itching; felt like bugs were all over body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) and RASH (felt like bugs were all over body) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Amputation (Leg amputated below the knee). Concurrent medical conditions included Diabetic, Renal failure, Liver failure, Blind (Blind in one eye) and Dialysis. Concomitant products included INSULIN for Diabetes mellitus, APIXABAN (ELIQUIS), LISINOPRIL, ISOSORBIDE, METOPROLOL and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced PRURITUS (itching) and RASH (felt like bugs were all over body). At the time of the report, PRURITUS (itching) and RASH (felt like bugs were all over body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications also included 4 different eye drops. Treatment details included diphenhydramine.
First few days just fatigue and wore off by day 3.  It's day 5 and I still have a huge, and growing, red rash-like at injection site. This is warm to the touch, hurts, and inflamed. Itchy throat, numb tongue, and metallic taste (even when not eating).
Immediate acute swelling of right deltoid area. Tender but non erythematous. Advised ice compress and Motrin. Vaccines received: Hep A and Meningococcal.
Narrative: Documenting VAER as required for pt who died and received COVID vaccine months before.
Sore left arm day after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left arm day after the vaccine) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore left arm day after the vaccine). At the time of the report, VACCINATION SITE PAIN (Sore left arm day after the vaccine) outcome was unknown.            No concomitant medication information was provided. No treatment medication were provided. No adverse event for both dose 1 and 2.   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Follow-up received and contains no new information.
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Medical history and concurrent condition were not reported. On 06-JUN-2014 the patient was vaccinated with the first dose of GARDASIL, 0.5 ml dose, intramuscularly. On 30-JUL-2014 was vaccinated with the second dose, 0.5 ml dose, intramuscularly, the third dose was given on 08-DEC-2014 and the patient received a fourth dose of GARDASIL 0.5 ml dose, intramuscularly. No symptoms reported. Additional information has been requested.
I have Headache; fever; chills; sore throat; muscle aches; congestion
4/3/03: Telephone call to county health department from pt voice concern regarding possible cardiac reaction post smallpox vaccination. Employee health nurse relayed pt's concerns and will follow up with pt. 4/4/03: Client seen in ED of hospital, had cardiac work up, no problems were discovered. Having trouble sleeping, he received anti anxiety medication. Pt voice concerns because his live in girlfriend had MI and by-pass surgery in the time since he had the smallpox vaccine. Pt to follow up with MD at hospital for any further concerns. 4/21/03: TC received from hospital stating nurse has heard rumor that pt is upset about the smallpox vaccination. TC placed to pt, message left to contact. 4/22/03: TC received from pt stating that he began having concerns about 1 1/2 weeks after receiving the vaccination. Explained that received a letter from the hospital on 4/1/2003, regarding the cardiac updates. He described the above info and added that he decided to make an appointment with a cardiologist. Had cardiac work up; put on Nitroglycerin for chest pain. Results expected 5/2/2003. He will call with results. TC to state health office advised VAERS is not appropriate unless the cardiologist's report indicated need. 8/3/03: TC received from hospital. Nurse stated she heard that pt had an appointment with infectious disease physician. 8/26/03: TC to state health office regarding pt's ongoing concerns, record faxed. 8/29/03: Received Email confirming receipt of record. State health office advised VAERS form appropriate given vaccine's complaints of symptoms.
08/26/2005 Hives at legs, back, chest and arms, very itching 2 days ago. No difficulty in breathing. No fever, No joint pain.
Client woke up with tenderness. Rash on upper left side of back consistent with shingles rash.
COVID 19 Treatment/returned/ rebound COVID; COVID 19 Treatment/returned/ rebound COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 14Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 68 years 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: "CAD" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: Jan2022, stop date: 22Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment/returned/ rebound COVID". The patient received COVID 19 Treatment Paxlovid from 22Jun2022 to 27Jun2022, and on 06Jul2022, symptoms returned/ rebound COVID. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.
30 minutes after receiving the shot, patient started smelling a chemical smell.  She had lost all sense of smell previously, but that changed to smelling and tasting a chemical smell that hasn't gone away or diminished.  She also experienced a couple of days of nausea and tiredness.
Moderna Covid-19 Vaccine EUA On 8th day following injection, the arm became red, hot, hard, sore, extremely itchy. Continued for about 11 days with symptoms beginning to decrease at about the 7th day following onset.  It is now 11th day following onset of reaction and arm is still slightly pink (looks bruised) and slightly itchy. Applied ice, Benadryl cream, and took antihistamines, none of which seemed to help very much.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 61 years old (also reported as 64 years old when administered vaccine) female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In January 2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for prophylaxis. As a result of her receipt of zoster vaccine live (ZOSTAVAX), in May 2014, the patient suffered shingles, including any and all of its sequelae and had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain. As a result of her receipt of zoster vaccine live (ZOSTAVAX), the patient suffered shingles and other related health complications. In addition, the patient requires and will continue to require healthcare and services. The patient has incurred and will continue to incur medical and related expenses. The patient also has suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The patient's direct medical losses and costs include physician care, monitoring, and treatment. The patient has incurred and will continue to incur mental and physical pain and suffering. The outcome of the event was considered not recovered/not resolved. The event was considered related to zoster vaccine live (ZOSTAVAX).  The lawyer considered the event to be medically significant and disability.
1) Event: Unilateral Tinnitus (right ear) on 5/16/21 9PM turned into Bilateral Tinnitus on 5/17/21 7AM (~12kHz tone and slight ~4kHz tone both in both ears).  Sleep is interrupted  Treatment:  None Outcome: Saw primary care (5/25/21), had an audiogram and tympanometry (5/27/21) showing normal hearing, and saw ENT (6/10/21).  Bilateral Tinnitus and resulting interruped sleep persists.  2) Slight dizziness accompanied the Unilateral Tinnitus only (5/16/21 9PM)
Information has been received from a female pharmacist concerning herself who in earlier 2008 was vaccinated with a first and second dose of RECOMBIVAX HB.  The reporter reported that she had been experiencing some visual disturbances after she received her RECOMBIVAX HB vaccine.  She started to have blurred visions on her left eye.  She went to see an ophthalmologist and was diagnosed with optic neuritis.  No further information was available.  The patient had not recovered.  Additional information has been requested.
Employee c/o muscle aches and pain to legs when standing, but goes away with walking. In April states increase in pain to his knees with movement. He rates his pain on scale of 0-10 at a 10 level. Employee spouse was given the same vaccines at the same time and had no reaction reported.
Dizziness; Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE, unknown manufacturer), for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown".  The lot number for the vaccine BNT162b2 (COMIRNATY), was not provided and will be requested during follow up.