chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sx ST congertion cough mild 06May  then Ag positive 09May; Sx ST congertion cough mild 06May  then Ag positive 09May; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Dec2021 as dose 1, single (Lot number: FF2589) at the age of 22 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09May2022, outcome "unknown" and all described as "Sx ST congertion cough mild 06May  then Ag positive 09May". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09May2022) Positive, notes: COVID-test type post vaccination: Unknown. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received any other vaccines within 4 weeks prior to the COVID vaccine was reported as unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events: "Drug ineffective", COVID-19" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.
No adverse events known. Patient received dose 2 of MODERNA at 19 days after their first dose. Administering provider was thinking Pfizer dose timeline, and allowed Moderna dose too early.
Tightness in chest, chest congestion without cough , or fever. Need not seek medical attention .
Wife says patient is experiencing a lot of soreness and limited range of motion of arm.  He is having significant pain with movement of arm and some stiffness in hand.
Information has been received from a nurse referring to a patient of unknown age and gender. Concurrent condition and medical history were not reported. On 24-FEB-2016 the patient was vaccinated with improperly stored M-M-R II (lot # L015279, expiration date 30-APR-2017, dose and route were unknown). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pain and swelling moved from left arm, up shoulder? Into neck (swollen), down right shoulder.  I could not work a full day of work (sitting at computer). I had to do PT for 6 weeks.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender who on an unknown date, was vaccinated with 1st and 2nd dose of RECOMBIVAX HB (lot# not reported). Medical assistant additionally reported that patient has not received dose three of RECOMBIVAX HB yet, and it has been eight months. No adverse effects reported. Additional information is not expected.
approx 10 minutes after injection, pressure in head and chest, sweating, blue lips, and white face, mostly lost vision for 10 minutes. recovered at 10 minutes then just exhausted. better next day except fatigue.
felt horrible; arm hot; achy; stayed in bed all day; chills; low grade fever; she wouldn't track (her eyes were fluttering); face got white; arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPSIA (she wouldn't track (her eyes were fluttering)), PALLOR (face got white), PAIN IN EXTREMITY (arm hurt), FEELING ABNORMAL (felt horrible) and FEELING HOT (arm hot) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Headache.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PHOTOPSIA (she wouldn't track (her eyes were fluttering)), PALLOR (face got white) and PAIN IN EXTREMITY (arm hurt). On 27-Feb-2021, the patient experienced FEELING ABNORMAL (felt horrible), FEELING HOT (arm hot), PAIN (achy), BEDRIDDEN (stayed in bed all day), CHILLS (chills) and PYREXIA (low grade fever). On 26-Feb-2021, PHOTOPSIA (she wouldn't track (her eyes were fluttering)) and PALLOR (face got white) had resolved. On 27-Feb-2021, PAIN IN EXTREMITY (arm hurt) had resolved. On 28-Feb-2021, FEELING ABNORMAL (felt horrible), FEELING HOT (arm hot), PAIN (achy), BEDRIDDEN (stayed in bed all day), CHILLS (chills) and PYREXIA (low grade fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   The patient used ice on hurt arm.
First two days after injection arm was swollen and it hurt to raise arm.  Could not lift arm above head.  Pain subsided and mobility increased over the next 4 weeks, but was still very painful to put pressure on injection site and move arm in certain ways.   Called nurse and was recommended to take ibuprofen, and use ice on area.  3 weeks later little to no improvement was noticed.  Called nurse again and was recommended to continue ibuprofen and ice and rotate in heat and also to massage the area.  A few days after this with little improvement I schedule a video doctor's apt (the quickest apt I could get) for April 13.  By the time of the doctors apt the pain was localized to about a dime sized area.  Painful and tender when pressure is applied.  Painful to move arm in certain ways such as reaching over head and touching left shoulder and putting right hand on hip and pushing elbow forward.  Photos were sent to doctor to show where the pain was occurring and where the injection site was.
I received the first Pfizer covid 19 vaccine on 8/2/21.  On 8/5/21 I began experiencing intermittent stabbing pain in my left shoulder deltoid muscle.  Over the following days, the pain became more frequent and severe.  By 8/8/21, a shingles rash developed on my left shoulder and arm.  On 8/9/21, I went to immediate care and was diagnosed with shingles and prescribed 4 medications: Valacyclovir, 1Hm 3x/day, 7 days Prednisone 20mg, 2x/day, 5days Acetaminophen with codeine 300/30 every 6hrs Hydrocortisone cream 2.5% 2x daily  On 8/10/21 I have 9/10 stabbing deep muscle pain in my left deltoid for about 30 minutes that literally brought me to my knees.  Since then, the intermittent pain went away and has turned into a constant 5/10 pain in my left arm.  I went to my primary doctor on 8/12/21 to follow up, he prescribed gabapentin, which is not really helping with the pain.  As of today 8/20/21, I continue to have 5/10 pain in my right arm.  I am not sleeping well.  The pain is definitely effecting my daily functionality.
Dose #3 given too soon.  Dose #3 given 8 weeks from Dose#1 (not dose#2).   Family will be notified.  Pt doing well.  No adverse affects as of 9/27/22.
Pt developed pain and a very large urticaria with heat at sites. 11cm on one leg and 7cm on the other leg. Give Benadryl and it took it away in about 12 to 15 hours. DX: Allergic reaction with local induration of 11cm.
After receving Varivax vaccine in left arm. Employee began feeling "off" within 3-4 hours.  Area below injection site red, warm to touch and swollen.  Has been applying cold compress to area.  Denies nausea, vomiting etc. Instructed to continue to apply compresses, apply topical Benadryl and take Benadryl po.
Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Tingling in left foot. eye is sensitive to light.
Sometime in 2022, I noticed that my toes were numb. My doctor said it was probably diabetes. But it wasn't. I found that I was losing my balance, usually when standing or starting to walk or getting up from a chair. I happened to mention it to my rheumatologist Dr. When I went to see him in February 2023, he told me I had Chronic Inflammatory Demyelinating Polyneuropathy. I was give IVIG infusions in July 2023 and have been getting infustions every 3 weeks.
Having difficulty staying balanced when standing; Very weak and intermittent pain on left side of arm, neck and face; Very weak and intermittent pain on left side of arm, neck and face; Very weak and intermittent pain on left side of arm, neck and face; Very weak and intermittent pain on left side of arm, neck and face; This is a spontaneous report from a contactable other healthcare professional, the patient. A 42-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 04Mar2021 at 17:45 (at the age of 42-year-old), as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN) and atenolol (MANUFACTURER UNKNOWN); all for unspecified indication from unknown date and unknown if ongoing. The patient previously received paracetamol; oxycodone hydrochloride (PERCOCET) for unspecified indication from unknown date and experienced drug allergy. On 04Mar2021 at 19:45, the patient experienced difficulty staying balanced when standing and felt very weak and experienced intermittent pain on left side of arm, neck and face. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events having difficulty staying balanced when standing and was very weak and intermittent pain on left side of arm, neck and face was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
A 4-inch in diameter spot swelled up on my arm, turned bright red, was hot and itched and it lasted 9 days. Although the symptoms decreased over that time, the reaction far exceeded the 2-3 day period that is in all the literature on this drug.
first dose Pfizer, second dose Moderna; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (first dose Pfizer, second dose Moderna) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-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 INTERCHANGE OF VACCINE PRODUCTS (first dose Pfizer, second dose Moderna). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (first dose Pfizer, second dose Moderna) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Reporter answered yes to bot's question that they are having side effect and received Moderna COVID-19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reporter answered yes to bot's question that they are having side effect and received Moderna COVID-19 vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reporter answered yes to bot's question that they are having side effect and received Moderna COVID-19 vaccine). At the time of the report, VACCINATION COMPLICATION (Reporter answered yes to bot's question that they are having side effect and received Moderna COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was provided. Treatment information was not provided.    Reporter did not allow further contact
symptoms of a bad cold with aches and pains, no fever/tested positive on a home test/confirmed as positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 at 17:15 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset 11Oct2023, outcome "unknown", described as "symptoms of a bad cold with aches and pains, no fever/tested positive on a home test/confirmed as positive for COVID". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient reported that he and his wife both received the Comirnaty 2023-2024 Covid 19 vaccine on Monday, 09Oct2023 at 5:15 PM, within minutes of each other. By Wednesday night, 11Oct2023, the patient started developing symptoms of a bad cold with aches and pains, no fever. He tested positive on a home test on Thursday morning, 12Oct2023. He went to an urgent care clinic on Friday morning, 13Oct2023, and they did a nasal swab. Yesterday, 15Oct2023, he got the results from the urgent care test and it was confirmed as positive for COVID. He does work frequently in the hospital so he might have picked it up there. Two days ago on Saturday, 14Oct2023, his wife started developing symptoms and tested positive on a home test that Saturday. She has not had a regular clinic test yet.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300331521 same reporter/drug/event, different patient;
myocarditis; shortness of breath; chest pain; fever; chills; myalgia; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis), DYSPNOEA (shortness of breath) and CHEST PAIN (chest pain) in a 31-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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criteria hospitalization prolonged and medically significant), DYSPNOEA (shortness of breath) (seriousness criterion hospitalization prolonged), CHEST PAIN (chest pain) (seriousness criterion hospitalization prolonged), PYREXIA (fever), CHILLS (chills) and MYALGIA (myalgia). The patient was hospitalized from sometime in 2021 to sometime in 2021 due to CHEST PAIN, DYSPNOEA and MYOCARDITIS. The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of UNK dosage form. At the time of the report, MYOCARDITIS (myocarditis) was resolving and DYSPNOEA (shortness of breath), CHEST PAIN (chest pain), PYREXIA (fever), CHILLS (chills) and MYALGIA (myalgia) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, C-reactive protein: high (High) 14 (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range). On an unknown date, Ejection fraction: abnormal (abnormal) 34%, generalized hypokinesis. On an unknown date, Electrocardiogram: normal (normal) normal left ventricular function. On an unknown date, Magnetic resonance imaging: abnormal (abnormal) Patchy subepicardial and midmyocardial delayed enhancement. On an unknown date, SARS-CoV-2 test: negative (Negative) negative. On an unknown date, Troponin: high (High) Baseline 39.5 (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range) and high (High) peak 46 (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was hemodynamically stable, no clinical heart failure. Concomitant medication not provided.  Company Comment  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Severe worsening of tinnitus. I don't remember exactly when but it was it was very noticeable the following day after receiving the first shot (and very possibly that night) and continued to worsen for the next few days. I've have very mild tinnitus most of my life, however this is *far* worse than anything I have ever experienced (can hear it very clearly over day-time background noise, conversations, etc. whereas before could only hear it when it was relatively quiet.) It has been 3 weeks and has not abated, and in fact is probably continuing to grow worse. It is probably noteworthy that within minutes of receiving the shot, a got quite light headed and my face felt slightly numb for a period of an hour or two. These symptoms went away, however the tinnitus has not.
INJ. PAIN  3/11/2021 TIREDNESS  3/12 &13/2021 HEADACHE 3/11 & 12/ 2021 MUSCLE PAIN  3/11 & 12/2021 CHILLS  3/12  & 13/2021 JOINT PAIN  3/11/12/13/2021 FEVER  3/12/13/2021  102.5  &  100.2 FEELING UNWELL  3/12/13/2021  I JUST KEPT TAKING TYLENOL TILL I FELT BETTER. I AM FINE TODAY.  3/14/2021
Lymphadenopathy in left arm (contralateral to injection site) Soreness in right arm (injection site)
Like an upset stomach; Tired/ Fatigued; Diarrhea; Joint pain in my knees; Nausea; This spontaneous case was received on 03-Nov-2020 from other non-health professional (consumer) via agency (reference number: SEQW20-04689) and concerned an elderly male patient of an unknown age.  The patient had no relevant medical conditions. The patient's concomitant medications included magnesium, fish oil, chondroitin and B12 (cyanocobalamin) (store products), all for unreported indications.   On 03-Oct-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, anatomical location: left arm; route of administration: not reported) for influenza prevention. The batch number reported was 279811, and expiry date: 30-Jun-2021.  On an unknown date in Oct-2020, two to four days after receiving Fluad Quadrivalent, the patient was tired, fatigued and had diarrhoea. He had no muscle aches and did not feel it. The patient had joint pain in his knees when he was going up and down the stairs and also had nausea when woke up in the morning like an upset stomach. The patient had no treatment associated with events.   The outcome of the events was unknown.   The reporter did not provide a causality assessment.  The reporter assessed the events as non-serious.   Company comment: An elderly male patient was vaccinated with Fluad Quadrivalent. Two to four days after receiving Fluad Quadrivalent, the patient developed fatigue, diarrhoea, arthralgia, nausea and abdominal discomfort. Reportedly, the patient had no relevant medical conditions. Causal role of the suspect vaccine is assessed as possibly for all events.; Sender's Comments: An elderly male patient was vaccinated with Fluad Quadrivalent. Two to four days after receiving Fluad Quadrivalent, the patient developed fatigue, diarrhoea, arthralgia, nausea and abdominal discomfort. Reportedly, the patient had no relevant medical conditions. Causal role of the suspect vaccine is assessed as possibly for all events.
unspecified adverse event; This case was reported by a lawyer and described the occurrence of adverse event in a female patient who received DTPa (Reduced antigen) (Boostrix) for product used for unknown indication.   On an unknown date, the patient received Boostrix (unknown). On an unknown date, an unknown time after receiving Boostrix, the patient experienced adverse event. The action taken with Boostrix was unknown. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Boostrix.  Additional information: On May 22, 2017, based on the information from GSK's advertisement that receiving this product could help plaintiff protect her newborn granddaughter, the plaintiff expended time and resources to travel to her local pharmacy where she requested and was injected with this product. The Plaintiff later found out that the information she received from GSK's advertising campaign is false and misleading because while this product may provide some protection in the recipient from manifesting symptoms of pertussis, it does not prevent asymptomatic infection and silent transmission of pertussis.
No adverse event; Patient received bivalent Moderna COVID19 vaccine as a first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received bivalent Moderna COVID19 vaccine as a first dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 011h22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jan-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient received bivalent Moderna COVID19 vaccine as a first dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received bivalent Moderna COVID19 vaccine as a first dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received bivalent Moderna COVID19 vaccine as a first dose).    It was unknown if the patient received any other vaccines in 4 weeks prior to COVID-19 vaccine.  No concomitant medications was reported. Patient received only one dose.  No treatment medications was reported.   Reporter did not allow further contact
Breakthrough COVID First dose 2/19/2021. 91-year-old Hispanic male presented to the emergency department via EMS agonally breathing, extremely short of breath for 2 days and was found unresponsive/agonal.  Initially tested negative on 8/1/2021 and detected with SNF transfer on 8/25/2021.