chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SORE ARM; BRUISE ON CALF; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unknown) dose was not reported, administered on 15-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced bruise on calf. On 15-APR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm and bruise on calf was not reported. This report was non-serious.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On 02-JAN-2018, the patient was vaccinated with a dose of M-M-R II (strength, dose, route, anatomical location, lot #, expiration date and therapy type were not reported) for prophylaxis; and on 10-JAN-2018, the patient was vaccinated with a dose of VARIVAX one vial, subcutaneously, once, lot # N014630, expiration date: 11-MAY-2019 (strength, anatomical location) for prophylaxis. Other suspect therapies included sterile diluent (MERCK) subcutaneously, once, lot # M039200, expiration date: 03-MAY-2019 (strength, anatomical location) for prophylaxis. No adverse effects were reported.
Started with a scratchy throat for a couple of days.  Second day began to get fatigued.  Third to fifth days had occasional achy joints, mild fever, chills, sore throat, plugged ears. Doctor prescribed Paxlovid on third day. Began feeling better on fifth day. By seventh day back to normal.
08Mar90 pt recvd booster vax; 20May90 devel swollen glands base of skull size of pea & sore. Devel sore knees & wrists & by 27May90 joints were swollen & rash on hands, legs, feet. Fingers swollen to the point that could not write.
Felt dizzy and jittery and flushed.  HR elevated by NSR.  Monitored for greater than 1 hour with symptoms occurring on and off during that period.  At 1025 she felt flushed again with report of scratchy throat.  No distress noted.  Oxygen sats 100%.  No itching or hives noted. No swelling of the face or airway but since she continued to have symptoms she was placed in wheelchair and taken to the ER.
I had side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I had side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I had side effects). At the time of the report, VACCINATION COMPLICATION (I had side effects) outcome was unknown.            No concomitant medication reported. No treatment information was provided.
Abdominal rash, red swollen hot injection site, headache, chills, lethargy.
Extremely drowsiness; Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 at 16:30 as dose 4 (booster), single (Lot number: GH9697) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: High cholesterol. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, on 21Oct2022 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (Primary immunization was completed, unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: SOMNOLENCE (non-serious) with onset 26Oct2022 at 19:00, outcome "recovering", described as "Extremely drowsiness"; FATIGUE (non-serious) with onset 26Oct2022 at 19:00, outcome "recovering", described as "Tiredness". Therapeutic measures were not taken as a result of somnolence, fatigue.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received flu vaccine within 4 weeks prior to the vaccination. The patient received other medications within 2 weeks. The patient had unspecified known allergies.  Follow-up (31Oct2022): Follow-up attempts are completed. No further information is expected.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 12-AUG-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 injection, lot # 1660991, expiration date 27-APR-2021 (exact dose, dose number, vaccination site and route of administration were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursions of 1.1 degrees Celsius for 27 hours and 45 minutes and 9 degrees Celsius for 1 hour and 15 minutes on 04-AUG-2020. There were no previous temperature excursions. Digital Data Logger was involved. No further adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Trigeminal Neuralgia with severe face pain.  Gabapentin prescribed.  Still experiencing pain.
Rash where the flu shot was given; red angry spot where the flu shot was given; Initial information received on 08-Oct-2019 and additional information received on 09-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA281611 and 2019SA281538 same reporter.  This case involves a 2 years old female patient who experienced rash where the flu shot was given (vaccination site rash) and red angry spot where the flu shot was given (vaccination site erythema), while she received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines administered.  On 02-Oct-2019, the patient received a 0.25 mL dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (Frequency =4) lot UJ223AA, Expiration Date: 30-Jun-2020 via intramuscular route in the left thigh.  On an unknown date, the patient developed a non-serious rash where the flu shot was given (vaccination site rash) and red angry spot where the flu shot was given (vaccination site erythema) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  (Other relevant tests included no lab data.)  Final diagnosis was red angry spot where the flu shot was given and rash where the flu shot was given.   The patient was treated with ACETAMINOPHEN (ACETAMINOPHEN), PREDNISONE (PREDNISONE), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and IBUPROFEN (IBUPROFEN).  The outcome of the event was Unknown.  Documents held by sender: none.
pt recvd vax 5OCT93 & was admitted to hosp 18OCT93 to r/o encephalitis; pt is in ICu in a comatose state;
Information has been received from a female consumer with a history of shingles who was vaccinated on an unspecified date with ZOSTAVAX (Oka/Merck) (Dose, route and Lot # not reported).  The consumer reported that on an unspecified date "I got the shingles through the nerve in my left arm down to my fingers with all the symptoms, of course, the blisters, pain and swelling".  "My doctor told me later that the shot had live cultures in it and that most patients get shingles from it".  The consumer reported that this was the third time that she had shingles.  At the time of the event, the outcome was unknown.  Upon internal review, shingles was considered to be disabling.
Started running fever approximately 3:30 pm on 1/26/2021, took Tylenol approximately 5:30 pm on 1/26/2021 after a hot shower. Sore throat and pain behind ears started approximately 4:00 pm on 1/26/21 and took Claritin and mucinex approximately 5:30 pm on 1/26/21.
worsening of arthritis; arms and legs hurt all the time now and that wasn't the case prior to the vaccine; Has a difficult time lifting arm still.; Exhausted; Felt weak; Dry throat; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt weak), DRY THROAT (Dry throat), ARTHRITIS (worsening of arthritis; arms and legs hurt all the time now and that wasn't the case prior to the vaccine), LIMB DISCOMFORT (Has a difficult time lifting arm still.) and FATIGUE (Exhausted) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 038C21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced ASTHENIA (Felt weak), DRY THROAT (Dry throat) and FATIGUE (Exhausted). On an unknown date, the patient experienced ARTHRITIS (worsening of arthritis; arms and legs hurt all the time now and that wasn't the case prior to the vaccine) and LIMB DISCOMFORT (Has a difficult time lifting arm still.). On 17-Jun-2021, ASTHENIA (Felt weak), DRY THROAT (Dry throat) and FATIGUE (Exhausted) had resolved. At the time of the report, ARTHRITIS (worsening of arthritis; arms and legs hurt all the time now and that wasn't the case prior to the vaccine) and LIMB DISCOMFORT (Has a difficult time lifting arm still.) outcome was unknown. Not Provided          Concomitant medications also included multiple unspecified medications for underlying conditions.  Patient reported to have taken juice as treatment a day after the onset of events after which she felt the events resolved.   This case was linked to MOD-2021-228462 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Added 2 new events.
Shivering; pain at injection site; Fatigue; Muscle Pain; Headache; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced shivering, injection site pain, fatigue, myalgia and headache. On an unknown date, the outcome of the shivering, injection site pain, fatigue, myalgia and headache were recovered/resolved.   It was unknown if the reporter considered the shivering, injection site pain, fatigue, myalgia and headache to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced headache, shivering, pain at injection site, fatigue, and muscle pain from his 1st Shingrix. The patient stated that the symptoms lasted for two to two and one half days.  The reporter did not consent to follow up.
Information has been received from a physician concerning a 2 year old male patient no pertinent medical history and no drug reactions/allergies, who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) in approximately June 2006 at approximately 1 year of age. The patient was adopted at 8 months of age and have been in contact with biological mother during her pregnancy. She had no history of chickenpox or zoster during pregnancy and the patient had not had chicken pox. On 29-SEP-2007 the patient had one week of fever followed by 10 vesicular lesions on left arm(8), 1 on lower hand and 1 on the back in midvertibral line. Herpes zoster - dermatome C6-C7. The lesions and fever are resolved. On 05-OCT-2007 diagnostics studies performed included: FAMA 1:64 and IgM<2. The crusted lesions sample was obtained on 05-OCT-2007 from his back, (waiting for other samples to arrive). The patient did not have a recent exposure to chickenpox or shingles. There was no product quality complaint. Follow-up information has been received. The patient was enrolled in the Varicella Zoster Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the Oka/Merck vaccine VZV strain. The sample of the lesion was collected on 05-OCT-2007. The sample was taken from a back lesion crust. The PCR results for the specimen identified the presence of: Vaccine. Additional information has been requested.
This spontaneous report was received from a 71 year old male patient, reporting on himself. The patient did not have any medical history to report. His concurrent conditions included a drug reaction or allergy to iodine; and his concomitant medications included LIPITOR, atorvastatin, "blood pressure pills", amlodipine, Metoprolol, allopurinol and escitalopram. On 24-NOV-2009, the patient was vaccinated with ZOSTAVAX one injection, for shingles (strength, dose, route of administration, lot number and expiration date were not reported). The patient informed that on 26-JAN-2018, he was temporary blind in one eye for 50 seconds after being vaccinated. The patient visited his eye doctor and a blood flow test was performed (results not provided). No treatment was given for the adverse event. On the same day, the patient recovered from the event. The causal relationship between the vaccination with ZOSTAVAX and the event was not provided by the reporter. Upon internal review, temporary blind in one eye was determined to be a medically significant event.
Rash below injection site and rash on opposite arm by wrist. Took BENADRYL. Rash clearing up. No additional problems.
P/vax pt exp convulsions. 2 other pt reported w/same exp (WAES97050306 & 98032330).
Patient reported dizziness, weakness, being freezing cold, shaking and sweating at the same time and reported being very weak and confused following the vaccine.  (not within 4 hours of administration;  patient did NOT seek any additional care)
Fever- took Tylenol went to bed, woke up @ 5am on 9/30/09 and had expressive dysphasia. Went to the ER, admitted to hospital. After MRI, CT, blood cultures negative-- EEG showed seizure activity. Dysphasia starting resolving within 24 hours.
Angioedema severe burning in the chest and esophagus, Swelling og eyes, face, neck, hands, knees and feet, feet so swollen toes did not touch floor. has a condition: Acute Urticaria Narrative:  Possible life threatening illness. Administered an Epi-pen and took 40 mg prednisone. Fluid retainage around the eyes, hands, neck, knees, face and feet. It's also accompanied with severe burning in the chest and esophagus. Eye almost swollen shut and feet so swollen toes did not touch floor. resolved after medications in 2 hours. has condition calles acute urticaria
I had about 20 min of being fuzzy headed. I couldn't remember the names of people I've known all of my life, including my best friend and boss. I couldn't think of a town I had vacationed to. My daughter could tell by looking at me that something was wrong. My nephew took me to the ER. They CT Scan, EKG, COVID test, blood work and took my vitals. My BP was 196/84. They gave me IV meds to decrease my BP. They needed to do an MRI, so I was sent by ambulance. They didn't find anything new and my BP had gone down by that time. I was sent home around 4:30am. I was told to follow up with cardiologist and neurologist. I see the cardiologist on 6/14, but I can't get in with the neurologist until August. I was also instructed to rest and I'm still pretty fatigued, so that's what I've been doing.
On 12/04/2000 the patient developed 6 pox lesions, a runny nose and nasal congestion. Additional information has been requested.
Patient development joint symptoms first, near Christmas 2007  Then after several months (March 2008)developed a serious kidney problems and was diagnosed with Lupus erythematous.   She is currently undergoing intermittent chemo treatment with a Pediatric Rheumatologist in Omaha, Nebr.  Date of vaccination was her second HPV(Gardasil) Her first was 8/14/2007 at same clinic, location and same manufacturer of vaccine.   (This may have been reported previously from a relative in the family who is a pharmacist.)
Vasovagal syncope. She began to get very warm, then fainted and became very pale. She was better within 5 minutes.
Worse brain fog; Fatigue,tired; Muscle aches; Nausea; Chills; Sweats; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERHIDROSIS (Sweats), FEELING ABNORMAL (Worse brain fog), FATIGUE (Fatigue,tired), MYALGIA (Muscle aches) and NAUSEA (Nausea) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypotension, Arrhythmia and Fatigue. Concurrent medical conditions included Chronic fatigue syndrome, Fibromyalgia and Neurocardiogenic syncope.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced HYPERHIDROSIS (Sweats), FATIGUE (Fatigue,tired), MYALGIA (Muscle aches), NAUSEA (Nausea) and CHILLS (Chills). On 17-Jan-2021, the patient experienced FEELING ABNORMAL (Worse brain fog). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. On 17-Jan-2021, HYPERHIDROSIS (Sweats), FATIGUE (Fatigue,tired), MYALGIA (Muscle aches), NAUSEA (Nausea) and CHILLS (Chills) had resolved. On 27-Jan-2021, FEELING ABNORMAL (Worse brain fog) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator     This case was linked to MOD-2021-116657 (Patient Link).
Narrative:  COVID infection following COVID vaccine series 02/23, Pfizer, dose #1 03/16, Pfizer, dose #2 08/30, Pfizer, dose #3 12/20 CXR impression: Stable examination. No acute cardiopulmonary pathology identified at present. 12/27 CXR impression: No focal airspace opacity. 12/27 COVID swab, result: detected 12/26 pt cc: diarrhea, myalgias, rhinorrhea, exposure: unknown 1/1 pt admit to Medicine cc: "crohn's flare up" abd pain x 3 days" DX: Covid infection, acute kidney injury LOS: 8 DAYS 1/1 BNP: 14,4 1/1 SARS-COV-2 IGG: 0.01 1/1 FIBRINOGEN: 485 1/1 DDIMER: 0.68 1/1 CRP: 0.446 1/1 PROCALCITONIN <0.05 1/1 SARS-COV-2 Variant Sequencing: pending 1/1 CT ABD/PEL W/O impression: 1. No acute abnormality in the abdomen and pelvis. No evidence of bowel inflammation or obstruction. Colonic diverticulosis. Bilateral nonobstructing renal calculi. 2. Some minimal patchy groundglass opacity in the right lower lobe which could be inflammatory or postinflammatory. 1/1 CXR impression: No radiographic evidence of acute cardiopulmonary disease. Please note that early/mild COVID-19 pneumonia may be radiographically occult, and groundglass opacities seen on same day comparison CT abdomen and pelvis are not apparent on this examination. 1/2 FIBRINOGEN: 465 1/2 DDIMER:0.531/2 ESR: 34 1/3 FIBRINOGEN: 391 1/3 DDIMER: 0.39 1/3 ESR: 35 1/4 ESR: 11 1/5 FIBRINOGEN: 360 1/5 DDIMER 0.39
Vaccination was received in the morning. By 2100, itchiness of hands and feet was noted but not suspected as a reaction.  Awoke at 0530 with full body itchiness and itchy, warm, hard welt the size of a quarter at the injection site. Arose from bed at 0800 and took Benadryl. Proceeded to keep upon Benadryl dosing every 4-6 hours for the next 2 days.  In the afternoon on the day following the vaccination, in addition to feeling all over intense itchiness (no sign of rash anywhere other than at injection site), felt a tingly, pins and needles sensation all over upper body any time Benadryl started to wear off. The whole body itchiness and tingly, pins and needles sensation lasted 36-48 hours but was kept under control with Benadryl.  Localized reaction at injection site increased in size for 72 hours. On day 3 post injection, it was noted that the size of the red area/hardness was approximately 3 inches in diameter with streaks down the arm and was very warm to touch. Allergist was consulted at previously scheduled appointment and prescribed antibiotics (azithromycin) and steroids (methylprednisolone) due to concern for infection. Antibiotic and steroid courses were completed and all symptoms resolved. Note-redness resolved 2 days into dosing but itchiness occurred for another 1-2 weeks if patient was warm or exercising. Due to concern that an allergic process occurred,, Allergist advised that similar COVID-19 vaccine not be received in the future.
Patient is currently still experiencing left arm soreness/tenderness off and on at the injection site. It worsens the more he uses his arm. Patient has not followed up with PCP yet, but pharmacy did recommend for him to do so.
pt recv vax 9MAY97 & 19MAY97 pt devel a varicella consisting of gen rash w/greater than 50 lesions on face, trunk & arm, lymphadenopathy &  a sore throat;
12/17/2020 Pfizer Covid vaccine 1/7/2021 Pfizer Covid vaccine 7/24/2021 covid exposure to son 7/28 became ill 8/5/2021 tested positive for Covid- PCR test 8/8 Potential to return to work
MISCARRIAGE- Conceived and got pregnant March 28. Received 2nd dose of Pfizer vaccine April 2. Found out I was pregnant April 14th, and confirmed it with blood test taken April 15th. HCG levels at 57, putting me at around 3 weeks pregnant. Started bleeding April 18th and doctor confirmed a miscarriage is taking place.
Pt recvd 1st dose of Hep B vax on 28AUG91 & 5 days later devel an erythematous pruritic rash from shoulder to the elbow; Pts arm was 1 1/2 time larger than non-vaxed arm; also exp tingling of arm; tx DPH & Motrin & recovered following day;
Narrative COVID infection following COVID vaccine series 03/02 , Pfizer, dose #1 03/23 Pfizer, dose #2 08/20 pt cc: fatigue exposure: unknown 08/23 COVDI swab, result: detected
whole body aches and pain in left arm, low grade fever of 99.8, and vomiting.
Pt inadvertently given inadequate dose of Moderna vaccine, no signs or symptoms of adverse reaction noted