chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Omicron diagnosis; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Omicron diagnosis) 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.   In September 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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. In December 2021, the patient experienced COVID-19 (Omicron diagnosis). At the time of the report, COVID-19 (Omicron diagnosis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 test: positive (Positive) Positive(Omicron Variant).         Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. Patient reported she received the Moderna COVID-19 two-dose primary series.  Company comment: This spontaneous case concerns a female patient with an unspecified age, with no reported medical history, who experienced the unexpected non serious adverse event of special interest COVID-19, that occurred on an unspecified date (sometime in December 2021) approximately 3-4 months after receiving the third dose (booster) of mRNA-1273. The dates and interval between the first and second doses of mRNA-1273 vaccine were not specified. No clinical, laboratory or treatment details were provided. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a female patient with an unspecified age, with no reported medical history, who experienced the unexpected non serious adverse event of special interest COVID-19, that occurred on an unspecified date (sometime in December 2021) approximately 3-4 months after receiving the third dose (booster) of mRNA-1273. The dates and interval between the first and second doses of mRNA-1273 vaccine were not specified. No clinical, laboratory or treatment details were provided. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
BRAIN FOG; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included got covid-19, and concurrent conditions included alcoholic, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced brain fog. On 21-JUN-2021, Laboratory data included: Computerized tomography scan (NR: not provided) UNKNOWN, and Electroencephalogram (NR: not provided) UNKNOWN. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of brain fog was not reported. This report was non-serious. This case, from the same reporter is linked to 20210648429.
This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a adult male who received ENGERIX B adult (batch number AHBVB584AA, expiry date 6th November 2010). Co-suspect products included ENGERIX B adult (batch number AHBVB584AA, expiry date 6th November 2010) and ENGERIX B Adult (batch number AHBVB670AA, expiry date 11th April 2011). On 22nd July 2008, the patient received the 1st dose of ENGERIX B adult. On 18th August 2008, the patient received the 2nd dose of ENGERIX B adult. On 10th November 2008, the patient received the 3rd dose of ENGERIX B adult. On 10th November 2008, not applicable after receiving ENGERIX B adult and ENGERIX B adult, not applicable after receiving ENGERIX B adult and ENGERIX B adult and an unknown time after receiving ENGERIX B adult, the patient experienced drug dose administration interval too short. On 9th December 2008, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder and drug dose administration interval too short were unknown. It was unknown if the reporter considered the therapy non-responder to be related  to ENGERIX B adult, ENGERIX B adult and ENGERIX B adult. Additional details were provided as follows: The patient's initials or date of birth was not provided. The age at vaccination was not reported. On 10th November 2016, the patient received 3rd dose of ENGERIX B adult, which led to shortening of the vaccination schedule. On 9th December 2008, 29 days after receiving 3rd dose of ENGERIX B adult, the anti-HBs (hepatitis B surface antibody) titer was found to be less than 8mlU/ml. Thus, leading the patient to be a therapy non-responder.
I have net had any issues with my health until I received my second dose of the Phizer vacine, Lot #FA7485 You guys should be prosecuted to the full extent for lying to the public. I hope that there will be criminal acts taken upon you sham of our government, I am experiencing all the signs of GBS now and it?s not right, including everything from ?puns & needles in my hands, arms, burning of the back you name it I have begun experiencing all of the signs. There is nothing false about what I am writing here and I expect a call do your job and get this pandemic under control but don?t blame it on the healthy and don?t expect for the healthy to take the Phizer vacine I did this for the common good and now I?m sick this is bull and expect a call!!!!
Weird taste; This case was reported by a pharmacist via call center representative and described the occurrence of taste peculiar in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number Xy22f, expiry date unknown) for prophylaxis.   Concomitant products included alprazolam.   On 3rd February 2023, the patient received the 1st dose of Shingrix. On 3rd February 2023, less than a day after receiving Shingrix, the patient experienced taste peculiar. On an unknown date, the outcome of the taste peculiar was not recovered/not resolved.   It was unknown if the reporter considered the taste peculiar to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-FEB-2023 Reporter's Comment: The reporter called to inform that earlier that day, a patient began to had a weird taste on the mouth after receiving the Shingrix.  The symptoms were not treated. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. Additional Supportive Information: This case was identified as duplicate of the case US2023017399. All future correspondence was submitted to US2023017283.
Immediate numbness of entire face, dizziness, resolving without intervention after two hours. Ten hours later experienced extreme gastric reflux requiring OTC meds and sleeping sitting up. Reflux diminished overnight, but was replaced with extreme nausea and loss of appetite. Twenty-four hours after vaccination, severe vomiting occurred, lasting two hours straight. Used rectal promethazine, which resolved symptoms within 20 minutes, complete after 1 hour. Loss of appetite continued through the next 7 days.  Other less severe  symptoms included injection site pain, fatigue and chills, all of which resolved after 2 days.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Patient hospitalized within 6 weeks of receiving COVID vaccination for angina at rest. He had Coronary artery bypass grafting x3 - left internal mammary artery grafted to LAD and reverse saphenous vein grafts placed to obtuse marginal and right posterior descending coronary arteries on cardiopulmonary bypass.
Fever Cough Body Aches Heaches Congestion runny nose Diarrhea
Allergies; nose is stuffy; scratchy throat; sinus drainage; sinus infection; felt tired, stayed in and out of bed for two weeks; bad headaches; felt like she had the flu; the injection made her sick; had weakness; had dizziness; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like she had the flu), ILLNESS (the injection made her sick), ASTHENIA (had weakness), DIZZINESS (had dizziness) and SINUSITIS (sinus infection) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy, Hypertension, Migraine, Heart disease, unspecified and Palpitations.    On 18-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 INFLUENZA LIKE ILLNESS (felt like she had the flu), ASTHENIA (had weakness), DIZZINESS (had dizziness) and FATIGUE (felt tired, stayed in and out of bed for two weeks). 20-Feb-2021, the patient experienced ILLNESS (the injection made her sick) and HEADACHE (bad headaches). On 11-Mar-2021, the patient experienced SINUSITIS (sinus infection). On 18-Mar-2021, the patient experienced HYPERSENSITIVITY (Allergies), NASAL CONGESTION (nose is stuffy), THROAT IRRITATION (scratchy throat) and SINUS DISORDER (sinus drainage). At the time of the report, INFLUENZA LIKE ILLNESS (felt like she had the flu), ILLNESS (the injection made her sick), ASTHENIA (had weakness), DIZZINESS (had dizziness), SINUSITIS (sinus infection), HYPERSENSITIVITY (Allergies), NASAL CONGESTION (nose is stuffy), THROAT IRRITATION (scratchy throat), SINUS DISORDER (sinus drainage), FATIGUE (felt tired, stayed in and out of bed for two weeks) and HEADACHE (bad headaches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 24-Feb-2021 patient was given allergy shots by her HCP.  Patient was taking concomitant medications, but could not recall the names of the medications. Second dose scheduled on 18-May-2021 was noted.
Patient had a severe allergic reaction that required a dose of 50mg Benadryl and 2 doses of epi-pen 0.3mg. 911 was called and EMS arrived.
Pt stated that 1 shot was given in the left shoulder/arm joint and that the 2nd was given in the back of the arm. In less than an hour, the left arm became swollen; eventually became 4" larger than the right arm. PMD's dx: Cervical nerve plexus, secondary to placement of shots. Left arm hurt, felt heavy, fingers drawn up. Treatment: cold/heat packs to arm. Swelling reduced by half as of 11/21/2000.
PCR test next day positive; PCR test next day positive; thought I was having a stroke; NVD; HA; Killer fatigue; A 32 year-old male patient received bnt162b2 (BNT162B2), administration date 25Feb2021 (Lot number: EL3247) at the age of 32 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Lot number: EL3247, dose number=1), administration date: 05Feb2021, when the patient was 31 years old, for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant) with onset 18Jan2022, outcome "unknown", SARS-COV-2 TEST POSITIVE (medically significant) with onset 18Jan2022, outcome "recovering" and all described as "PCR test next day positive"; CEREBROVASCULAR ACCIDENT (medically significant) with onset 17Jan2022, outcome "recovering", described as "thought I was having a stroke"; RETINAL NEOVASCULARISATION (medically significant) with onset 17Jan2022, outcome "recovering", described as "NVD"; HYPERAMMONAEMIA (non-serious) with onset 17Jan2022, outcome "recovering", described as "HA"; FATIGUE (non-serious) with onset 17Jan2022, outcome "recovering", described as "Killer fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Jan2022) positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of sars-cov-2 test positive, cerebrovascular accident, retinal neovascularisation, hyperammonaemia, fatigue. It was reported that severe symptoms 17Jan2022 after work NVD and "killer fatigue and HA". Patient thought was having a stroke" had a PCR test next day positive.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between the LOE events, Cerebrovascular accident, Retinal neovascularization, Hyperammonemia, Fatigue the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
It was reported that a male pt received a TD Adult vaccination, intradermal on 01/27/2001 at 11am. Reportedly on 01/26/2001 at 11:30pm the pt developed 1/4cm raised center with 1cm margin-erythemic down from 3cn erythemic margin. The pt reportedly recovered from this experience.
Initial report received from a health care professional on 12 Feb 2010: This 2 year old patient was vaccinated with FLUVIRIN (batch no. 102131P1) on 11 Feb 2009. The patient's outcome was not reported.
This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 12-AUG-2013 (conflicting information), the patient was inoculated with ZOSTAVAX at a physician office as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 08-AUG-2013 (conflicting information), the patient was treated at a physician office for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was considered related. Additional information has been requested.
2 days p/vax pt complained of swelling & redness to lt upper arm. on inspection lt upper arm noted to be slightly red, swollen & hot to touch.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No information on concurrent conditions and medical history were not reported. Approximately in April 2015 (dates ranging from 28-APR-2015 through 29-APR-2015), the patients were vaccinated with improperly stored RECOMBIVAX HB (unknown dose and route) lot # K014548 and expiry date of 27-AUG-2016. Concomitant medications were not reported. No adverse effects were reported. The outcome of incorrect product storage was unknown. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Fever 100.2;severe headache;severe neck ache,sweating,shivering,upset stomach,weak,joint pain
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 88 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date in 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
HEADACHE; BODY ACHES; CHILLS; This spontaneous report received from a parent concerned a 25 year old male. The patient's weight was 155 pounds, and height was 69 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980,  expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 11:00 on left arm  for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and chills on 02-APR-2021, and had not recovered from headache. This report was non-serious.
Bronchial pneumonia; Blood clot; joint pain in shoulders, wrist and arms; Flu symptoms; chills; fever; his SED rate and it is coming back low to normal; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration in left Arm on 14Jan2021 (age at vaccination 71 years) as DOSE 1, SINGLE for COVID-19 immunization. The patient Medical history included low thyroid, cholesterol and blood clot issue from an unknown date and unknown if ongoing. The patient concomitant medications included Levothyroxine 125mcg tablet for Low thyroid, Atorvastatin for Cholesterol, Cholecalciferol (D3), Glucose (D5) from an unknown start date. On an unspecified date 2021, the patient experienced Bronchial tube slightly enlarged, joint pain in shoulders, wrist and arms this happened seven days after each vaccine. In the first case he was given steroids and got relief. Then 7 days after the 2nd vaccine the same has happened. He wanted to know that had you had other patients reporting similar symptoms. He had flu symptoms such as chills, fever and he also had some other issues including blood clots and Bronchial pneumonia treated with antibiotics and prednisone (treatment). The patient underwent lab tests and procedures which included MRI on one shoulder and his rheumatologist was checked his SED rate and it was coming back low to normal. Patient went to his GP and he had had history of blood clots, so he did Blood work or something Chest X-ray and then CT and saw bronchial tube was slightly enlarged, when probe if reports were normal, consumer stated, yes red blood cell sedimentation rate. The patient had blood test for platelet and results was low. The patient took Tylenol 4-6 a day because of his low platelets. He was on blood thinner Warfarin, Centrum for 20 years they took off that in 2019, but still take Tylenol because of low platelet. The outcome of event pneumonia and joint pain was recovered on an unspecified date and rest of all events were unknown.  Information about lot/batch number has been requested.
PT RECEIVED INFLUENZA VACCINE ON 11/14/2022. A HISTORICAL INFLUENZA VACCINE WAS RECORDED IN PATIENT'S CHART AS ADMINISTERED FOR 11/01/2022.
100% blockage in the right coronary artery .  Symptoms: heartburn type pain, passed out, pain from chest around right shoulder
Narrative:  Patient received two doses of Moderna COVID 19 Vaccine in Mar/Apr 2021. The patient tested positive for COVID 19 on 12 Jan 2022. The patient presented to the ED with weakness. The patient was admitted to the hospital on 12 Jan 2022 with DKA, Acute kidney injury, and covid infection. The patient's covid symptoms turned into sepsis. The patient was treated with antibiotics, was intubated, and the patient's condition worsened. The patient died on 22 Jan 2022 due to intracranial bleed, Sepsis, due to COVID pneumonia and hyper-coagulopathy. Reported per EUA.
broke out into rash; looks like could be shingles; This is a spontaneous report from a Pfizer-sponsored program  from a contactable consumer reported for self. This female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient had 1st dose of Covid vaccine. Last Sunday (in 2021), patient broke out into rash, looked like could be shingles. The 2nd dose of vaccine was this Wednesday. Patient wanted to know if she should get the 2nd dose. HCP told patient to get vaccine but she wanted suggestion. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient received vaccine at 10:29am. Upon walking toward post-vaccination area, patient fainted at 10:30am. He struck his head on the ground when he passed out. Patient regained groggy consciousness at 10:31am and was able to answer basic questions and seemed somewhat alert. Cold compress was applied to head and neck. EMS was called to assess patient for potential concussion. Patient was taken to local emergency room for follow up assessment/treatment
Lots of redness on arm, numbness, headache - lasted 4 days.  Patient okay now but wanted to make sure it got reported.