chrisvoncsefalvay/vaers-outcomes huggingface dataset:
States began to feel lightheaded the evening shot was recvd; c/o dizziness only;
On 7/5/99, the pt started with headache, nausea, ataxia, and double vision. Dxed with Guillain-Barre syndrome. Admitted to hospital and stayed for 11 days. No problems since then.
Next day had hive-like rash over both legs from the hips down. Some affected areas with itching.  Topical Benadryl,. oral Benadryl followed by appointment with NP 9/7/21. Prescribed oral prednisone on this date.  No improvement noted.
Vaccination caused severe body aches and revived pain in right leg from car accident 05/29/2020. The pain had previously abated 12/2021. The pain persists today.
Breakthrough case admission after 3 vaccines Moderna 3/15/21 Lot#030A21A;  Moderna 4/12/21 Lot# 018B21A;  Moderna 12/22/21 Lot# 070H21A
pt recvd vax; approx 1 day later felt as if she were getting the flu;she then had difficulty breathing & exp elev BP; tx at er & recovered;
Pt had tightening & some burning in her throat. No difficulty with breathing or swallowing. Given 25mg of benadryl PO.
"lymph node swelling under right axilla"  Narrative: Reported on 6/10/2021 & was "ongoing" at that time.
hand swelled; This is a spontaneous report received from a contactable reporter(s) (Other HCP). A male patient received BNT162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "not recovered", described as "hand swelled". Additional information: The patient experienced hand swelled and his hand was still swollen weeks later after an injection.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
metallic taste in my mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic taste in my mouth) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-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 experienced DYSGEUSIA (metallic taste in my mouth). At the time of the report, DYSGEUSIA (metallic taste in my mouth) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    This case was linked to US-MODERNATX, INC.-MOD-2021-076353 (Patient Link).
Low grade fever, excessive mucus leading to vomiting and weakness, on going cough. I had to call in sick on 9-26-14 too weak to drive to work.
her baby's pediatrician told her the patient could pass antibodies to the baby through breastfeeding; her baby's pediatrician told her the patient could pass antibodies to the baby through breastfeeding; headache; light sensitivity; vision changed; extreme fatigue /Exhaustion; overall body aches; sweaty /Sweating Profusely; her pupils were dilating and constricting; her pupils were dilating and constricting; Brain Fog; This is a spontaneous report received from a contactable consumer (patient). The consumer reported information for both mother and baby. This is the maternal report.  A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 20Apr2021 at age of 36 years at single dose for COVID-19 immunisation. Medical history included ongoing asthma, had basically had all of her life; since she was about 8 years old. Her grandfather had strokes. Her father died of a heart attack. Patient had no concomitant medications. Patient received her first Pfizer Covid vaccine dose on 20Apr2021. She stated that after the vaccine was administered (on 20Apr2021), she started to experience extreme fatigue and needed to sleep. After waking up from a nap, she noticed vision changed, headache with light sensitivity, overall body aches, and sweaty. Her husband told her that her pupils were dilating and constricting. Her MD advised her to go to the ED. Patient stated why the patient taking covid vaccination was asthma, medical worker and having a 9-month-old baby. Patient stated that she had been experiencing vision problems and a severe headache. Said her pupils had been dilating and contracting. Patient had severe headache, vision problems; pupils keep dilating and contracting, exhaustion, brain fog, sweating profusely on 20Apr2021. Said her symptoms started yesterday 20Apr2021, stopped, and then started again today. Stated she had questions about her side effects and asked should she go the Emergency Room; especially for the headache. Said today they were just as bad as yesterday; except she was not as exhausted today as she was yesterday. Patient stated that her main reason was because her baby's pediatrician told her the patient could pass antibodies to the baby through breastfeeding. Patient denied any medications, labs, testing, or treatments relevant to report. AE(s) did not require a visit to Emergency Room and Physician Office. Patient stated no adverse events after prior vaccinations; only an antibiotic. Outcome of exhaustion was recovering and the other events was not recovered.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021446591 Same reporter/drug, different patient/event (baby case)
Pain at the time of injection; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Pain at the time of injection) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Post polio syndrome and Intrathecal pump insertion (Morphine pump) in September 2015. Concurrent medical conditions included Unable to walk since 2000.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Pain at the time of injection). On 10-Mar-2021, VACCINATION SITE PAIN (Pain at the time of injection) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE PAIN (Pain at the time of injection) to be possibly related.    Concomitant medications included an intrathecal morphine pump surgically inserted in Sep 2015.  No treatment medications were provided by reporter.   This case was linked to MOD-2021-112646 (Patient Link).
10 to 12 minutes after the vaccine administration Observing pharmacist reported that patient was turning pale and continued to be pale after few minutes. Patients mother reported that it does happen to him often. Called paramedics as precautionary and paramedics suggested to take him to the hospital. Patient was transported in the ambulance for further evaluation. Could not reach the patient or the Mother to follow up
SIRVA: shoulder pain began right away and never went away. Bruise at injection site high up on arm, almost in shoulder. 2 30-day courses of Meloxicam and now physical therapy 2x per week
COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Multiple sclerosis exacerbation. Concurrent medical conditions included Dementia, Weight gain, Wheeze worsened, Memory impaired, Difficulty in walking and Aspiration pneumonia. Concomitant products included OCRELIZUMAB (OCREVUS) and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced COVID-19 (COVID) (seriousness criterion hospitalization). The patient was hospitalized from sometime in 2022 to sometime in 2022 due to COVID-19. In 2022, COVID-19 (COVID) had resolved.            Patient's concomitant medication included monoclonal antibodies.  On 20-Apr-2021, patient started therapy with MODERNA COVID-19 VACCINE for Prevention of Covid. She was never tested for any antibody production after she received her COVID-19 vaccinations. patient was hospitalized for COVID, about 4 months ago in 2022.  No treatment information was provided.  Company comment: This spontaneous case concerns a 63 year old female patient with no relevant medical history, who experienced the unexpected serious (hospitalization) AESI of COVID 19 , unknown days after receiving the third dose (first booster)of mRNA-1273 vaccine. Patient received the primary series of vaccination with mRNA-1273 vaccine in accordance with the recommended schedule. No further information on detailed clinical course, investigations and treatment details of the event was available in the report. The COVID 19 pandemic could be a confounder for the event COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-610564 (Patient Link).; Sender's Comments: This spontaneous case concerns a 63 year old female patient with no relevant medical history, who experienced the unexpected serious (hospitalization) AESI of COVID 19 , unknown days after receiving the third dose (first booster)of mRNA-1273 vaccine. Patient received the primary series of vaccination with mRNA-1273 vaccine in accordance with the recommended schedule. No further information on detailed clinical course, investigations and treatment details of the event was available in the report. The COVID 19 pandemic could be a confounder for the event COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report.
16 hrs after vaccination, I was awakened with severe deltoid pain. Then headache, chills, weakness, diarrhea, nausea began. I took 1 extra strength Tylenol for headache 3 hrs ago. Headache continues. Previous Covid vaccines were Pfizer. This 4th dose was moderna. My husband is having the same symptoms
"Approximately 15 minutes following the patient's initial vaccine shot, the observation nurse reported that patient began to feel throat tightening, and feeling clamy. Observation nurse also noticed that patient's voice began to become raspy. The nurse checked the patient's vitals and reported that they were normal, and proceeded to take the patient to the ED for further evaluation. Patient received diphenhydramine 25mg IV x 1, famotidine 40mg PO x 1, methylprednisolone 125mg x 1.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Aug2022 at 20:00 as dose 6 (booster), single (Batch/Lot number: unknown), in left arm 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), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ankylosing spondylitis" (unspecified if ongoing); "Post surgical hypothyroidism" (unspecified if ongoing); "Allergy: Sulfa" (unspecified if ongoing), notes: Allergy: Sulfa. Concomitant medication(s) included: LEVOTHYROXINE oral, start date: 01Jan2022, stop date: 26Sep2022. Past drug history included: Levaquin, reaction(s): "Drug allergy", notes: Allergy: Levaquin; Humira, reaction(s): "Drug allergy", notes: Allergy: Humira; Enbrel, reaction(s): "Drug allergy", notes: Allergy: Enbrel. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) positive, notes: positive antigen test on day 12 after first positive PCR test on 14Sep; (14Sep2022) Positive, notes: positive PCR test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received Paxlovid for the treatment of COVID-19 from 16Sep2022 to 22Sep2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported COVID-19 positive after BNT162b2 COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Back pain lower 1st four hours. Stomach pain next day. Rash with hives and tightness of chest; could not breathe. Treatment: IV steroids and Benadryl. Constant break out for 5 days.
6 days after receiving injection, left upper arm became hot to touch with erythema, sharp pain and itchiness.
Vision disturbance for approximately one hour, included distortion of right eye field of vision. Vision was as if a bright light left me unable to see the middle area of my right eye field of vision.
This case was reported by a nurse via call center representative and described the occurrence of pruritus in a 54-year-old female patient who received FLUARIX. Concurrent medical conditions included celiac disease. Concomitant products included ZETIA and Atorvastatin. On 2nd October 2015, the patient received FLUARIX .5 ml. On 3rd October 2015, 1 days after receiving FLUARIX, the patient experienced pruritus. On 4th October 2015, the patient experienced skin inflammation, inflammation and redness. The patient was treated with BENADRYL. On an unknown date, the outcome of the pruritus, skin inflammation, inflammation and redness were not recovered/not resolved. The reporter considered the pruritus, skin inflammation, inflammation and redness to be related to FLUARIX. Additional details provided were as follows: This was reported by a patient herself. The patient has Celiac disease and this was the typical reaction that she experiences when exposed to gluten. On 3rd October 2015, about 24 hours after receiving FLUARIX, the patient's jaw line began itching. On 4th October 2015, 2 days after vaccination, the itching spread to full face and down neck. Also she described as the area becoming inflamed and red. The patient was treated with BENADRYL, but it did not relieve the events.
no adverse event; temperature excursion with VAQTA which was administered to a patient; This spontaneous report was received from a medical assistance, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, drug reactions, concurrent conditions and concomitant therapies were not provided.  On 01-JUN-2021, the patient was vaccinated with an incorrect stored dose of hepatitis a vaccine, inactivated(VAQTA) lot # T020109, expiration date reported as 26-JAN-2022, dose reported as 0.5 milliliter, for prophylaxis (strength, route, frequency were not reported)..  The temperature excursion was of 47.1 Fahrenheit degrees (°F) during 15 minutes. A previous temperature excursion was not reported. A digital data logger was not involved. No adverse effects were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T020109; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Redness, swelling of face and neck with feeling of warmth.  Took OTC Allegra and was fine in 2 hours
Information has been received on 25-APR-2017 from a medical assistant regarding an unspecified number of patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. From 13-APR-2017 through 25-APR-2017, an unspecified number of patients were vaccinated with doses of PROQUAD lot # M043306, expiration 24-APR-2018 and lot # M042502, expiration 17-APR-2018 subcutaneous for prophylaxis which were improperly stored. Other suspect therapy included STERILE DILUENT lot # M034763 expiration 22-APR-2019. The vaccines were stored between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 4 hours and 14 minutes. There was no previous temperature excursion. The call was not made due to a data logger. The medical assistant confirmed that the STERILE DILUENT used to reconstitute the PROQUAD was not improperly stored. No adverse effects were reported. No further information was reported. Follow up information was received from the medical assistant on 17-MAY-2017, referring to a 4 year old female patient. The patient administered the vaccine on 21-APR-2017. The medical assistant reported that they did not exactly know what caused the temperature excursion in April 2017, but they were thinking the door to the refrigerator might have been left slightly open. There had been no temperature excursions since that time. All telephone attempts to obtain follow-up information on 17-MAY-2017 had been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA013406: US-009507513-1705USA014055: US-009507513-1705USA014056: US-009507513-1705USA014057: US-009507513-1705USA014058: US-009507513-1705USA014059: US-009507513-1705USA014060: US-009507513-1705USA014061: US-009507513-1705USA014062: US-009507513-1705USA014064: US-009507513-1705USA014065: US-009507513-1705USA014066: US-009507513-1705USA014067: US-009507513-1705USA014068.
Parkinson's disease; movements reduced; tiredness; headache; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of PARKINSON'S DISEASE (Parkinson's disease) in a 74-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 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PARKINSON'S DISEASE (Parkinson's disease) (seriousness criterion medically significant), HYPOKINESIA (movements reduced), FATIGUE (tiredness) and HEADACHE (headache). At the time of the report, PARKINSON'S DISEASE (Parkinson's disease), HYPOKINESIA (movements reduced), FATIGUE (tiredness) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case is reporter's husband case. The reporter's case number(case#MOD21-068417).  Very limited information regarding this events has been provided at this time.  However, 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.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  However, 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.  Further information has been requested.
Within 8 hours of injection, body aches all over and soreness and stiffness near injection. Fever and chills, weakness and headache developing within 12 hours of injection. Fever reached 103 degrees within 24 hours of injection. Pain and weakness worsened. Went to clinic then ER 26 hours after vaccine.
pt recvd vax;,exp mild vasculitic rxn p/2nd dose;w/in 30-45 mins p/dose 2 devel pain in lt axilla area;resolved;w/in 24 hrs,devel pruritic papular rash following hair follicles;biopsy showed vasculitis;rash resolved 7 days,itching in 2;
pt recvd vax & felt feverish & had swollen hands & feet; woke up w/ itchy skin & fever of 104; worsened swelling of hands, feet, lips; pt taken to ER; admitted to hosp;
JOINT PAIN; LEFT WEAK; CHILLS; TIREDNESS; NAUSEA; HEADACHE; FEVER; HYDRATING; ACHES,PAIN; This spontaneous report received from a patient via a company representative concerned a 58 year old female. 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, the batch number was not reported and has been requested, expiry: unknown) dose was not reported, administered on 31-MAR-2021 at 10:55 on left arm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced hydrating. On 31-MAR-2021, the subject experienced aches, pain. On 31-MAR-2021, the subject experienced joint pain. On 31-MAR-2021, the subject experienced left weak. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced tiredness. On 31-MAR-2021, the subject experienced nausea. On 31-MAR-2021, the subject experienced headache. On 31-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, nausea, and fever on 01-APR-2021, was recovering from headache, had not recovered from aches, pain, tiredness, and joint pain, and the outcome of hydrating and left weak was not reported. This report was non-serious.
He tested positive for Covid-19 on 05/09/2021 with a quick rapid test on the ER. They did a CT scan. They told us to go higher on the amount of oxygen we were using. They prescribed him steroids to help with his breathing. He told us to come back if it got worse. On 5/11/2021 I took him to the hospital and he was admitted and spent 17 days there with high flow oxygen and some monoclonal antibody steroids. He did not need to be intubated. He was discharged 05/28/2021.
Left arm - bump, about 1/2 size of tennis ball, hot, hard, redness, 11 days post vaccine, still there, but subsiding Headaches to base and temple of head described as sharp and disorienting. 11 days post vaccine, still occurring, but less frequently
Patient complained of pain in his left arm (especially when straightening). Also there was a noticeable swelling and a large red area around the injection site. This area of the skin was hot to the touch.  Patient also complained the area was "itchy."