chrisvoncsefalvay/vaers-outcomes huggingface dataset:
muscle weakness; twitching in legs, arms and feet; diarrhea; stomach acid burning; tingling numbness feeling; tingling numbness feeling; general feeling of unwellness; insomnia; fatigue; nausea; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (muscle weakness), MUSCLE TWITCHING (twitching in legs, arms and feet), DIARRHOEA (diarrhea), DYSPEPSIA (stomach acid burning) and PARAESTHESIA (tingling numbness feeling) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (muscle weakness), MUSCLE TWITCHING (twitching in legs, arms and feet), DIARRHOEA (diarrhea), DYSPEPSIA (stomach acid burning), PARAESTHESIA (tingling numbness feeling), HYPOAESTHESIA (tingling numbness feeling), VACCINATION COMPLICATION (general feeling of unwellness), INSOMNIA (insomnia), FATIGUE (fatigue) and NAUSEA (nausea). At the time of the report, MUSCULAR WEAKNESS (muscle weakness), MUSCLE TWITCHING (twitching in legs, arms and feet), DIARRHOEA (diarrhea), DYSPEPSIA (stomach acid burning), PARAESTHESIA (tingling numbness feeling), HYPOAESTHESIA (tingling numbness feeling), VACCINATION COMPLICATION (general feeling of unwellness), INSOMNIA (insomnia), FATIGUE (fatigue) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature abnormal: (abnormal) unable to regulate body temperature.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
(Ache in arm), chills, fever near 100 degrees all night, needed to urinate 3 times, became faint and couldn't walk alone.  In AM needed fluids and still felt faint. Very weak all day.  Took ibuprofen, fever went down, still weak and tired.  Better 11/09.
6/23/2021 - pain at injection site, shortness of breath 6/24 /2021 - found dead in bed at 7AM
31JAN97 150PM mom reported pt has been crying & screaming since vax @ 930MA;mom gave APAP x 2;also states rt leg is reddened & swollen @ inject site;instructed mom to put cool cloth on leg & call MD;
Information has been received from a medical assistant concerning a 13 year old male with environmental allergy who on 24-JAN-2007 was vaccinated with the first dose of Pneumovax 23 vaccine (lot#651399-0486F, expiration 08-MAY-2007), 0.5 ml, IM left arm. Concomitant mediation included influenza virus vaccine (unspecified) (patient requested flu vaccine to be administered in the same arm). and fexofenadine hydrochloride (ALLEGRA). On 25-JAN-2007, the patient called the physician's office and said that his arm was hurting. On 26-JAN-2007, the patient presented to the physician's office. On 26-JAN-2007, the patient went to the hospital with cellulitis of left arm and possible allergic reaction. The patient was treated with vancomycin and another medication. The physician stated that he considered the antibiotics an intervention to prevent serious criteria. The patient's cellulitis of left arm and possible allergic reaction persisted. Cellulitis of left arm and possible allergic reaction were considered to be disabling and other important medical event. Additional information has been requested.
VOMITING; SHORTNESS OF BREATH; CHILLS; NAUSEA; ANXIETY; DIZZINESS; This spontaneous report received from a patient concerned a 49 year old of unspecified sex. 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: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced anxiety.  On 13-APR-2021, the subject experienced dizziness. On 13-APR-2021, the subject experienced shortness of breath. On 13-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced nausea. On 17-APR-2021, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anxiety, and shortness of breath, and had not recovered from dizziness, nausea, vomiting, and chills. This report was non-serious.
Adverse reaction came on rather suddenly around 6 PM, eight hours after injection and progressed rapidly lasting almost 48 hrs.  Started with mild bodyaches that within an  our became moderate, followed by moderate chills, mild headache that came and went over the 48 hours, moderate fatigue, and extremely sore at injection site but no visible redness or bruising.  I did have a fever with the onset of the other symptoms. It started at 99.8 and then over the next 48 hours would fluctuate as high as 100.9 but never dropping below 99.8.
ZOSTAVAX is not effective beyond 3 to 5 years and only 50% effective originally; ZOSTAVAX is not effective beyond 3 to 5 years and only 50% effective originally; This spontaneous report was received from a female patient of unknown age regarding herself. Patient's medical history, concomitant medication and drug allergies/reactions were not reported. On an unknown date in 2009, (mentioned as 10 years ago), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route, strength, lot/batch and expiry: unknown) for prophylaxis. The patient called to verify the availability status of zoster rgE vaccine (mammalian) (SHINGRIX). The patient reported that her physician recommended zoster rgE vaccine (mammalian) (SHINGRIX), because the physician stated to her that the zoster vaccine live (ZOSTAVAX) was not effective (drug ineffective) beyond 3 to 5 years, and only 50% effective originally whereas zoster rgE vaccine (mammalian) (SHINGRIX) was 90% (therapeutic product effect decreased). Outcome and causality of the events were not reported.
left knee is swollen and tight; left knee is swollen and tight; pain in knee; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (left knee is swollen and tight), JOINT STIFFNESS (left knee is swollen and tight) and ARTHRALGIA (pain in knee) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jul-2021, the patient experienced JOINT SWELLING (left knee is swollen and tight), JOINT STIFFNESS (left knee is swollen and tight) and ARTHRALGIA (pain in knee). At the time of the report, JOINT SWELLING (left knee is swollen and tight), JOINT STIFFNESS (left knee is swollen and tight) and ARTHRALGIA (pain in knee) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported  Treatment information was not provided.
she can taste the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (she can taste the vaccine) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 047A21A and 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TASTE DISORDER (she can taste the vaccine). At the time of the report, TASTE DISORDER (she can taste the vaccine) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-433382, MOD-2021-433444 (Patient Link).
experiencing fatigue and injection site pain after receiving fourth dose of COVID-19 vaccine; experiencing fatigue and injection site pain after receiving fourth dose of COVID-19 vaccine; Wrong vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 34-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: 6JS342) for covid-19 immunisation. The patient didn't receive BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 Immunization.  The following information was reported: FATIGUE (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "experiencing fatigue and injection site pain after receiving fourth dose of COVID-19 vaccine"; WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "Wrong vaccine administered". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The female patient approximately 157 pounds, 5'1",experienced fatigue and injection site pain after receiving fourth dose of COVID-19 vaccine. Event took place after use of product.  No follow-up attempts are possible. No further information is expected.
Injection site rash; Injection site itching/circle on left arm at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (Injection site rash) and INJECTION SITE PRURITUS (Injection site itching/circle on left arm at site of injection) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041120A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included Thyroid Medicine for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced INJECTION SITE RASH (Injection site rash) and INJECTION SITE PRURITUS (Injection site itching/circle on left arm at site of injection). At the time of the report, INJECTION SITE RASH (Injection site rash) and INJECTION SITE PRURITUS (Injection site itching/circle on left arm at site of injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided
32 yo male with PMH of Schizoaffective bipolar disorder, HIV/AIDS, ESRD on dialysis (last dialysis session earlier on the day he went to the ED), hypertension, and PJP who received a first dose of the Moderna COVID Vaccine on 07/20/2021. He presented to the ED with chest pain, shortness of breath, slight fever (100.9 F), and nonproductive cough on 07/23/2021. On route the patient received 325 mg of Aspirin and nitroglycerin with no improvement of chest pain. COVID test came back positive and the X-ray showed an enlarged heart with pulmonary vascular congestion and interstitial edema. The patient was eventually admitted and treated with oxygen via NC, dexamethasone, albuterol, carvedilol, darunavir/cobicistat, tivicay, enoxaparin, guaifenesin, hydralazine, ipratropium, nifedipine, quetiapine, sevelamer, torsemide, voriconazole, and colchicine. Cefepime, tobramycin, vancomycin, meropenem, and gentamicin were the antibiotics used to treat the patients bacteremia. The cause of the pericarditis is most likely multifactorial, as the patient could have developed the ADR from the vaccine, COVID, kidney failure, or from HIV/AIDs. Given a Naranjo score of 3, the probability of a true ADR is possible when calculating the probability of the vaccine causing the ADR. Pt was discharged from the hospital on 08/05/21. Even though there may be an association between pericarditis and the vaccine, the infectious disease doctors that encountered this patient recommended the patient could receive the 2nd dose of Moderna to complete the vaccination series.
Information has been received from a physician (D.O.) concerning a 30-year-old who on 10-JUL-2006 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). Six weeks later, In August 2006, the patient experience a negative titer. On 21-AUG-2006, the patient was vaccinated with a second dose of varicella virus vaccine live (Ork/Merck). In November 2006, the patient again experience a negative titer. Subsequently, the patient did not experience any symptoms. Unspecified medical attention was sought. It was reported that the patient did not recover from the negative titer. no product quality compliant was involved. Additional information has been requested.
Information has been received from a physician concerning a 7 year old pt who on 12/09/1996 was vaccinated with a dose of varicella virus vaccine live. On 10/30/2003 the pt experienced a case of breakthrough varicella. There were less than 50 lesions. Unspecified medical attention was sought, but there were was no Tx and no hospitalization. The pt recovered. No product quality complaint was involved. This is one pt out of 40 reported. Thirty nine other cases (WAES 0407USA01446 and 0409USA01855 through 0409USA01871 and 0409USA01873 through 0409USA01893) experienced breakthrough varicella after vaccination with varicella virus vaccine live. Additioal inoformation is not expected.
dizziness; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 22 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Mar2021 14:00 (Lot number: ER8727) at the age of 22 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 31Mar2021, outcome "recovered", described as "dizziness"; PAIN IN EXTREMITY (non-serious) with onset 31Mar2021, outcome "recovered", described as "sore arm". Therapeutic measures were not taken as a result of dizziness, pain in extremity.  Additional information: Facility where the most recent COVID-19 vaccine was administered was reported as other. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received medication for asthma within 2 weeks of vaccination not sure what though. The day after receiving the vaccine he experienced severe dizziness which lasted more than 12 hours. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Injection site was hard but tender first few days. Itchy arm started on the 8th of February after inject on  afternoon of Jan 29  Next morning Feb. 9  red patch at injection site. Itching continues thru day.
This pt received a flu and pneumonia vaccine on 10/23/03. Pain, swelling and bruising to right deltoid, elbow and forearm. Treated with Ibuprofen. Resolved as of 11/14/03.
Rash, NauseaVomiting, lasted 3 days Narrative:  symptoms lasted 3 days
sorenes in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sorenes in the left arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced INJECTION SITE PAIN (sorenes in the left arm). On 22-Jan-2021, INJECTION SITE PAIN (sorenes in the left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Shoddier left inguinal nodes, swollen left thigh, mild erythema inner aspect, no induration at injection site.
Immediate extreme pain upward into the shoulder and joint. Severe pain for 30 hours then somewhat less severe for 4 weeks; slowly lessening pain but as of July 23rd still not able to have full use of arm; radiating pain in shoulder and downward below elbow and into hand.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 23-FEB-2015 the patient was vaccinated with VARIVAX (Merck) lot # K008819 (expiration date, dose, route, frequency and indication were not reported) that experienced a temperature excursion, which was later supported as well. There was no concomitant medication reported. At the time of the report, the patient's status was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
I received my 3rd dose of the moderna Covid-19 vaccine in my left arm on 12/18/21 around 11am. I received my first two doses of the moderna vaccine in February and March 2021.   The day after I got the vaccine I started having dryness around my eyes, which I thought may be due to a retinol skin product I had been using for the past 2 months, so I stopped using the skin product. Previously I had no issues with this retinol skin product.  The dryness around my eyes continued to get worse each day and I kept using a lot of lotion to help calm down the skin around my eyes. On 12/22/21 my left eye started looking puffy and the dryness got more extreme. I had to continually put lotion on around that eye throughout the day. On 12/23/21, the puffiness in my left eye got worse along with the dryness around my eye. Also, my vision in my left eye started getting a little blurry and my eye kept drying out to the point where I would have to keep my eye closed for like 15-30 seconds to re-moisten the eye. It was getting itchy and looked quite bad. I took 400 mg ibuprofen which helped temporarily reduce the irritation, but it was still very dry around the eye and on the eyeball itself.  My right eye seems to be improving while my left eye seems to be getting worse.
Sinusitis. A nsg practitioner reported that a 9month old infant received her 3rd Prevnar vaccine as well as hepatitis B on 1/18/01. Medical history includes diarrhea and sickness. On 2/13/01 the infant developed sinusitis and an upper respiratory infection. she was treated with Amoxicillin.
throat tightening and some difficulty breathing, given epi .3mg, paramedics called,  went to ER for obs
Chest tightness within an hour of the shot; Severe nasal congestion; Sore throat; Hard heavy sneezing about 60-70 times a day; Red itchy eyes; Red itchy eyes; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 15Apr2021 at 16:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had allergies to sulfa and environmental allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within 2 weeks prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 17:00, the patient experienced chest tightness within an hour of the shot and then severe nasal congestion with red itchy eyes, sore throat and hard heavy sneezing about 60-70 times a day. Therapeutic measures were taken as a result of the events and included treatment with allergy medicine loratadine (CLARITIN) and over the counter co. Since the vaccination, the patient had been tested for COVID-19. On 16Apr2021, 19Apr2021, and 23Apr2021, the patient underwent unknown rapid test which was done at school via nasal swab and the result was negative. The clinical outcome of the events chest tightness within an hour of the shot and then severe nasal congestion with red itchy eyes, sore throat and hard heavy sneezing about 60-70 times a day were resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Patient received the COVID 19 vaccine on 3/30/21 as part of the homebound program.  Per the obituary, he died at home on 6/12/2021.
h/a & congestion (nasal) as per employee noted 23MAR99 p/vax on 18MAR99 ( 5 days post vax);oral decongestant prescribed;
Child became weak and briefly passed out.  Regained consciousness immediately and had normal exam in emergency department.
neoplasm; lumps under their arm,Lump was large; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (lumps under their arm,Lump was large) and NEOPLASM (neoplasm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Amlodipine.), Hypertension and Drug allergy (Benazepril.). Concomitant products included AMLODIPINE BESYLATE from 06-Jun-2021 to an unknown date for Blood pressure.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced AXILLARY MASS (lumps under their arm,Lump was large). On an unknown date, the patient experienced NEOPLASM (neoplasm). At the time of the report, AXILLARY MASS (lumps under their arm,Lump was large) had resolved with sequelae and NEOPLASM (neoplasm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient has taken an eye ointment with an antibiotic and steroid.    Most recent FOLLOW-UP information incorporated above includes: On 07-Aug-2021: Reporter address, patient demographics, allergic condition, medical history, concomitant medication and event outcome and details were updated.