chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid-19 vaccine associated myocarditis.; This is a literature report.  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, 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: MYOCARDITIS (medically significant), outcome "unknown", described as "Covid-19 vaccine associated myocarditis.".  Clinical course: The mechanism of myocardial injury following mRNA-based vaccination remained uncertain, but it was postulated to reflect overaggressive T-cell activation following host-cell manufacturing of modified mRNA nucleosides of the SARS-CoV-2 virus, subsequently leading to myocardial injury through molecular mimicry. Whether this iatrogenic catalyst of myocardial injury results in a similar duration and cumulative burden of inflammatory injury compared with community-acquired viral myocarditis was previously unknown. A single case series of 5subjects was published casting preliminary insights from convalescent CMR-based findings following mRNA COVID-19 vaccination induced injury.; Sender's Comments: Based on the available information in the case, an association between the reported event Myocarditis and The suspected drug cannot be ruled out.  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.
Death Narrative: 73 yr old male with a history of CAD, HTN, HFrEF, CKD stage 4, COPD, HCV Cirrhosis and opioid dependence who presented with incarcertated ventral hernia 3 days post OP from ex lap, reduction of SB, closure of hernia primarily. He was off pressors but remained intubated due to poor mental status with unclear etiology. It could be related to liver failure, vs neurological insult vs renal failure. Head CT 4 days prior on the 2/24 were without acute intracranial pathology. Hepatology was consulted and did not believe the liver was the main etiology behind poor mental status. Patient progressively declined with continuously increased IV pressor requirement. ABG showed worsening lactate acidosis and was anuric. Patient's family was notified of decline and agreed for the patient to be transition to comfort care early 2/28. Bedside RN notified pronouncing physician of cessation of respiration and cardiac activity.
RED RASH UNDER BOTH EYES; CHILLS; FATIGUE; This spontaneous report received from a patient concerned a 22 year old male.The patient's height, and weight were not reported.  The patient's concurrent conditions included alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: 20-JUN-2021) dose was not reported, administered on 31-MAR-2021 on Left Arm for prophylactic vaccination. No concomitant medications were reported On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced fatigue. On 02-APR-2021, the subject experienced red rash under both eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fatigue on 02-APR-2021, and had not recovered from red rash under both eyes. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
mild allergy; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 58-year-old male patient received BNT162b2 (BNT162B2), on 26Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2 , Manufacturer: Pfizer, Batch/Lot No: EL3247), administration date: 17Feb2021, when the patient was 57-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Manufacturer: Pfizer, Batch/Lot No: EL3247), administration date: 27Jan2021, when the patient was 57-year-old, for COVID-19 Immunization. The following information was reported: HYPERSENSITIVITY (non-serious) with onset 15May2022, outcome "unknown", described as "mild allergy". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Facility where the most recent COVID-19 vaccine was administered was workplace clinic. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. On 16May2022, daughter exposed at school and tested positive on 17May2022 and he tested positive 18May2022 prior to vaccination. It was unknown if patient diagnosed with COVID-19. Since the vaccination, patient had been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
That evening started feeling aches, fever. Around 4:00am next day woke up felt as if I couldn't breathe, light headed and running fever was really scary. I took Ibuprofen didn't do too much. I continued to run fever of 102 for 48 hours. Then on 12/08/2021 my fever was still fairly high 100, exp chest pains and chest pains got worse upon me standing. I went to local ER had a EKG and my fever has finally went away. As of today still have pain in my left armpit.
Chest raised and heart fluttered for about 5 seconds.  This happened twice 5 days a part.
Hardened swelling and redness at injection shot several days after injection Lymph nodes in left armpit in pain several days after injection
p/vax pt had welt (wheal + flare) at inj site; faded by 30 minutes;
Pharmd attempted to administer 1st dose of SHINGRIX IM right deltoid and patient moved during the injection causing the needle to come out and scratch the surface of the skin. She complained that it burned and caused pain at the start of the injection. Pharmd had to administer another dose in the left arm which was administered without any incident or complaint. Patient  said at 8 pm that she is feeling fine and the pain was temporary after the 1st attempt.
Information has been received from a medical assistant concerning a 22 year old female patient with no pertinent medical history and no drug reaction/allergies who on 30-NOV-2009 was vaccinated IM with the first 0.5 ml dose of GARDASIL (Lot# 663453/0249Y). There was no concomitant medication. On 30-NOV-2009 the patient experienced headache, dizziness. She had taking SINUS EXCEDRIN which temporarily helped the headaches. Medical assistant also mentioned that when the patient initially received GARDASIL she complained of pain with the injection. The patient had called the office this morning to seek medical attention. There were no lab diagnostic tests performed. Patient had recovered from the arm pain but not the headache and dizziness. Additional information had been requested.
12/31/2022 20:17 observed moaning , 1/2/2023 - noted to be unrepsonsive to verbal and tactile stimuli 1/2/2023 deceased.
No Adverse Event; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No Adverse Event) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-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 started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On 05-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-620794 (Patient Link).
rash Initial report received from a RN in the USA on 9/29/05.  a 40 year old male pt developed a large banded rash below the injection site (specific injection site not reported) which completely wrapped around his bicep and into the axillae area the day after receiving the injection of Menactra, Lot number U1722AA in the righe deltoid on 9/27/05. The pt received in concomitant Pneumovax 23 (Merck) lot number 0791P in the left deltoid. The patient recovered.
Dizzy spells mainly later in the day or at night.  Started noticing them on April 11th, and have been off work since.
No adverse effects; Second dose was inadvertently administered as PROQUAD / patient's age: 27 years-old; This spontaneous report was received from a nurse concerning to a 27 year old patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported. The patient's pertinent past drugs included measles virus vaccine live (EndersEdmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (M-M-R II) and varicella virus vaccine live (Oka/Merck)) (VARIVAX).  On 29-AUG-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (strength, dose, frequency, route of administration, lot # and expiration date were not provided) (product administered to patient of inappropriate age). It was reported that a sterile diluent was used.
pain in his leg; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: but he immune system problems: asthma and allergies so that could be the reason; "Allergy" (unspecified if ongoing), notes: but he immune system problems: asthma and allergies so that could be the reason. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in his leg".  Additional Information: It was reported that, the patient received the second dose of the Pfizer-BioNtech Covid-19 vaccine on 19Apr2021 around 5:30PM in the next morning he got up and had a bagel with cream cheese for breakfast with his husband, his husband told him that the cream cheese was sour, but he could not taste that. He went to work and took a coffee and didn't have taste, it was like water, he had no taste or smell. Next day he went to the doctor to see what was going on if he had COVID-19 and he did a test (Tuesday 10:00AM) and it was negative (the smell and taste came back on Saturday) Next day (Wednesday) he could barely walk, had joint pain, headache and pain in his while body (like a horrible flu). The pain in his leg started after the first dose, however after the second dose the pain was worse, and it's been almost 3 weeks. On Saturday and Sunday, he felt better but he still has joint pain and in his bottom part is worse (leg). It was also mentioned that he feels very weak, has cold sweat all the time and some cough (but he immune system problems: asthma and allergies so that could be the reason). Caller received other 2 tests on Thursday or Friday (same week after second dose) and the results were negative.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
I experienced uncontrollable anger when I spoke to two of my friends on the phone. I was shaking so hard I dropped the phone. It was very out of character for me. I spoke to my primary care doctor and she told me to call her again if it happened again, but it has not happened recently.
Headache Narrative: Headache started on 01/06/2021 at 9:30 pm and lasted 01/08/2021 which dissipated early morning.
an improperly stored ROTATEQ vaccine was administered; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 20-OCT-2021, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1707496, expiration date 29-MAR-2022, experienced the temperature excursion of 51 degrees fahrenheit (F) for 4 hours and 15 minutes. On the same day after the excursion occurred, the patient was vaccinated with an improperly stored dose rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1707496 (formulation, concentration, exact dose, dose number, route of administration and anatomical location were not reported) for prophylaxis (product storage error). There were no previous excursions reported.
vertigo; arm pain at  injection site continued for the day; chills; vomiting; extreme body pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (extreme body pain), VERTIGO (vertigo), CHILLS (chills), VOMITING (vomiting) and VACCINATION SITE PAIN (arm pain at  injection site continued for the day) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022 at 11:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced PAIN (extreme body pain) and VOMITING (vomiting). On 06-Jan-2022 at 8:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (chills). On 07-Jan-2022, the patient experienced VERTIGO (vertigo) and VACCINATION SITE PAIN (arm pain at  injection site continued for the day). The patient was treated with DIMENHYDRINATE (DRAMAMINE) on 07-Jan-2022 for Vertigo, at an unspecified dose and frequency. On 08-Jan-2022, PAIN (extreme body pain), VERTIGO (vertigo), CHILLS (chills), VOMITING (vomiting) and VACCINATION SITE PAIN (arm pain at  injection site continued for the day) had resolved.            Concomitant medications were not provided by reporter.  The patient received Moderna booster on , thursday at about 11:30 AM. on the same day patient began to have chills around 8:00 PM; shortly thereafter vomiting followed by extreme body pain and in the AM woke up with vertigo and patient received OTC (Dramamine) to address verti go successfully, arm pain at  injection site continued for the day. By Saturday , patient back to normal.
Had the shot and got shingles/ suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had the shot and got shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 23-MAR-2023 This case was reported by patient via interactive digital media. The reporter reported that his or her sister received Shingles vaccine and experienced shingles This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow up was not possible as no contact details were available.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient said there was blisters around the injection site as well
Vaccine error report: On 11/20/2007, this 22-year old client received pediatric formulations of Hepatitis A and Hepatitis B.  Per CDC Info, client was notified that she should repeat the correct doses for both Hep A and B at her earliest convenience.  Repeat doses of adult formulations scheduled for 11/21/2007.  No adverse events.
He started complaining of chest pain & shortness of breath. Vitals and echocardiogram, fluid and inflammation, 600 milligram, four times a day of ibuprofen and omeprazole. Saw the cardiologist. Follow up in a week and kept the healthcare. After three weeks shortness of breath and heart rate getting better, healthcare said no to second dose.
Headache; Muscle pain; Joint pain; Chills; Fever; Feeling unwell; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 72-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: ER8727), via an unspecified route of administration in the left arm on 24Mar2021 at 10:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and high blood pressure. The patient had no known allergies. The concomitant medications included ibuprofen (MANUFUCTURER UNKNOWN), levothyroxine (MANUFUCTURER UNKNOWN), amlodipine (MANUFUCTURER UNKNOWN) and lisinopril (MANUFUCTURER UNKNOWN) taken for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: EN6202), via an unspecified route of administration in the left arm on 03Mar2021 at 10:00. 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 vaccination. Since the vaccination, the patient was not been tested for COVID-19. The patient underwent lab test and procedure which included body temperature and result was shown as 101-degree Fahrenheit. On 26Mar2021, at 18:00 the patient experienced headache, muscle pain, joint pain, chills, fever, feeling unwell and tiredness. No therapeutic measures were taken for these events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, muscle pain, joint pain, chills, fever, feeling unwell and tiredness was recovered on an unspecified date.   No follow-up attempts are needed. No further information is expected.
After administration, staff realized no diluent was used in vial.  Mother was notified by pharmacist and no issues were reported on 11/25/22. Pharmacist also followed up 11/26/22 and still no issues reported.
4-5 days after vaccines, developed white pustules on fingers. Lesions grew to size of 50 cent piece and spread to abdomen, back, legs, and arms. Hospitalized for 4 days for wound management including joint flushing and debridement. Continues to have difficulty. Patient continues to have limited movement in hands and is having physical therapy. Discharge Summary received on 4/20/2005 states infection viral. Per the follow up report- The RN has tried to contact the patient 3x's and left messages for a return call, but have not received any answer.
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a patient of unknown age and gender. The patient's medical history and drug allergies were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot# reported as L011085, expiration date 01-APR-2017, dose and route of administration were not reported). The patient's concomitant medication was not provided. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
arm soreness; tiredness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (the patient experienced 4 to 5 shingles outbreaks in 2018) and scar (the patient had scars from her previous shingles). Previously administered products included Zostavax.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm and tiredness. On an unknown date, the outcome of the pain in arm and tiredness were recovered/resolved.   It was unknown if the reporter considered the pain in arm and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received her 1st dose of Shingrix 6 months ago and experienced arm soreness and tiredness. The patient declined to provide her name and contact information. The case was linked to the case US2019AMR130538 reported by same reporter for same patient (2nd dose). There was discrepancy in age group reported in source document (infant) and it was reported as adult. The age group kept as adult as reported.
SCRATCHING; SCABIES IN ARM, SHOULDER AND LOWER BACK; ITCHINESS; RASH BELOW LEFT ARM; TIREDNESS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included kidney problems, liver problems, and vision problems. 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 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced rash below left arm. On APR-2021, the subject experienced tiredness. On 03-APR-2021, the subject experienced scabies in arm, shoulder and lower back. On 03-APR-2021, the subject experienced itchiness. On 04-APR-2021, the subject experienced scratching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from scabies in arm, shoulder and lower back, and itchiness, and the outcome of rash below left arm, tiredness and scratching was not reported. This report was non-serious.
Shingles on palm of left hand, painful blisters on palm on the surface of the left hand.