chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Phantosmia - cigarette smoke; This is a spontaneous report from a contactable consumer, the patient. A 52-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 31Mar2021 at, 17:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, GERD (Gastroesophageal reflux disease), depression and anxiety. The patient had known allergies to sulfa drugs. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), fluoxetine hydrochloride (PROZAC), pantoprazole sodium sesquihydrate (PROTONIX), levothyroxine sodium (SYNTHROID) and fish oil (MANUFACTURER UNKNOWN) all the drugs started on an unknown date, for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 the patient experienced phantosmia - cigarette smoke. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported event. The clinical outcome of the event phantosmia - cigarette smoke was not resolved.  No follow-up attempts are needed. No further information is expected.
Initial unsolicited report received from a physician on 28 August 2015. This case involves a 57 years male patient who was vaccinated with an intramuscular dose of ADACEL (batch number U5189AA, expiration date 28 October 2017) in left deltoid on 30 June 2015. The patient did not have any illness at the time of vaccination. Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as diabetes, hyperlipidemia, sleep apnea. Concomitant medications were not reported. On 30 June 2015, same day following the vaccination, the patient experienced persistent pain at the left deltoid, muscle seems to be wasting. When compare the size of his upper arms there is clearly a difference. Deltoid area was tender to touch. It was reported that on ROM (range of motion) when the patient abducts his movement was limited, but more likely due to the pain. No redness or swelling at the left deltoid. Patient required Emergency Room/physician visit. Lab data and corrective treatments were not reported. The patient had not recovered. List of documents held by sender: none.
Patient developed COVID after vaccination; She is now deceased; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (She is now deceased) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer (previously had cancer twice). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), NIFEDIPINE (PROCARDIA [NIFEDIPINE]), TICLOPIDINE HYDROCHLORIDE (TICLID), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.    On 22-Feb-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 COVID-19 (Patient developed COVID after vaccination). The patient died on 23-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, COVID-19 (Patient developed COVID after vaccination) outcome was unknown.            It was reported that the patient previously had cancer twice, and her immune system was not what it should have been. The patient got really, really sick and had COVID at some point after receiving the vaccine.  No corrective treatment was provided.  Action taken with the drug in response to the events was not applicable.  Company comment: Very limited information regarding this event has been provided at this time. Noting the subject had received 1st dose of vaccine prior to COVID. However, based on the mechanism of action of mRNA1273, the event COVID is unlikely related to vaccine.; Sender's Comments: Very limited information regarding this event has been provided at this time. Noting the subject had received 1st dose of vaccine prior to COVID. However, based on the mechanism of action of mRNA1273, the event COVID is unlikely related to vaccine.; Reported Cause(s) of Death: Unknown cause of death
Dizziness, nausea, temporary hearing loss, temporary loss of vision(black out), fever, chills, soreness, loss of appetite.
Pt received six vaccinations at time of visit on 6 Oct 2020. Pt reported to ER  on 17 OCT 2020 with rash and warmness of right leg without fever. ER diagnosed as cellulitis, oral Keflex ordered.
Heart pain , chest tightness , headache , joint pain , neck pain , shortness of breath .
Information has been received from a physician concerning a female with drug hypersensitivity to codeine who on 09-MAY-2007 was vaccinated with Gardasil. Concomitant therapy included Seasonale. In May 2007, the patient experienced left shoulder pain. An MRI showed that there was a focal fluid collected along the facial plane at the deltoid and infraspinatus muscle. The patient was treated with Advil and Aleve. The patient had begun to get some relief on 22-MAY-2007 but the pain had not resolved. No further details were provided. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a physician concerning a 23 year old female with drug hypersensitivity to codeine who on 09-MAY-2007 was vaccinated with a second dose of GARDASIL in the left deltoid. Concomitant therapy included SEASONALE. No illness at the time of the vaccination was specified. On 09-MAY-2007, the patient experienced left shoulder/deltoid pain. On 18-MAY-2007, an MRI showed that there was a focal fluid collected along the facial plane at the deltoid and infraspinatus muscle. The physician reported "that the MRI was reviewed with a radiologist and fluid collection appears to be edema, not blood, not infection/abscess". The patient was treated with ADVIL with no help and ALEVE with little help. The patient had begun to get some relief on 22-MAY-2007 but the pain had not resolved. The patient was to start physical therapy (date unspecified). The physician reported that the event may be related to the patient's recent GARDASIL. No further details were provided. Additional information has been requested.
Fever (range of 99.1 to 102.3), chills, vomiting, body aches at 5:00 am the morning following the vaccine. All of this plus fatigue continued for 5 days. I was unable to go to work or function normally until the evening of the 5th day. I took Advil as needed. Spoke to my primary care physician on day 4 because I was still so tired, nauseous and had a fever.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included lisinopril and lovastatin. On 31st May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 31st May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, axillary pain, pain and swelling. On 1st June 2018, the patient experienced headache. The patient was treated with naproxen. On 1st June 2018, the outcome of the headache was recovered/resolved. On 2nd June 2018, the outcome of the pain was recovered/resolved. On 4th June 2018, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the axillary pain was not recovered/not resolved and the outcome of the swelling was recovering/resolving. The reporter considered the injection site pain, axillary pain, pain, swelling and headache to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on Thursday afternoon at 1.00 pm in the left deltoid. The patient developed pain at the injection site which resolved on Monday evening. The patient also stated that, he had under arm pain and swelling near the pectoral muscle that was not resolved. The patient stated that, he experienced soreness and added that he experienced a headache, 1 day after vaccination on Friday which resolved with Naproxen administration.
Rash all lower back and  upper Torso, shoulders and buttocks area. prescription call in. Some type of steroid took for 8 days.
Approximately 6-8 hours after the vaccine experienced chills, body aches and developed 100.3 fever.  The night was miserable with fever, chills and dizziness when walking to the bathroom.  The next day low grade fever and chills that began to subside around 24 hours post vaccination.  For the next 48 hours had residual aches and fatigue.  Began feeling significantly better after the 72 hour mark.  However, after learning about blood clot issue has been having anxiety and some left sided pain that I'm not sure if it's anxiety or migraine related or possibly something worse.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 4/14/2021 and 5/5/2021. Covid-19 + in September, 2021. Patient presented to ED on 11/6/2021 for leg pain and diagnosed with severe cellulitis, denies injury to leg, found to be Covid-19 + upon admission. On 11/10/2021 patient began to complain of fatigue and increased dyspnea with increased oxygen requirements. Family elected for palliative care due to declining oxygen saturations despite NIPPV. Patient expired on 11/11/21.
On 3/18/00, the pt experienced shortness of breath while playing baseball and had to see his physician. Additional information has been requested.
PT RECEIVED EXPIRED FLUMIST DURING WELL CHILD CHECK. NO REPORTED ADVERSE EVENTS TO DATE OF COMPLETING REPORT.
Information has been received from a licensed practical nurse concerning a 30 year old female with no known allergies or pertinent medical history, who on an unspecified dates was vaccinated with first and second doses of MMR. There was no concomitant medication. Medical attention was sought. On 05-OCT-2006 blood was collected to test for measles, mumps, and rubella immunity. Lab results reported on 07-OCT-2006 indicated that the patient was immune to rubella with a serum rubella immunoglobulin antibody test of 13 IU/mL (>9 = immune) and measles with a serum measles immunoglobulin G antibody test of 1.99 (>1.09 = positive). The patient's serum mumps immunoglobulin G antibody test was <0.91 (<0.91 = negative/no immunity). No symptoms were reported. On an unspecified date the patient was re-vaccinated with a third dose of MMR. No further information was available. There was no product quality complaint involved. Additional information is not expected.
Developed generalized pruritic rash, starting on face and spreading to trunk and extremities.  Some facial swelling.  No shortness of breath, trouble swallowing, or airway problems.
Vomited x 4, dizzy (light-headed) starting at 1 p.m.
had a heart condition; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (had a heart condition) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced CARDIAC DISORDER (had a heart condition) (seriousness criterion hospitalization prolonged). The patient was hospitalized on sometime in June 2021 due to CARDIAC DISORDER. At the time of the report, CARDIAC DISORDER (had a heart condition) outcome was unknown.            Concomitant product usage were not provided. Treatment details were not provided.  Caller stated that her father had a heart condition and was admitted to the hospital in June 2021.  He was later released (exact release date unknown).  The caller stated her father's heart condition had nothing to do with the Moderna vaccine in her opinion.  Company Comment: This case concerns a male subject of unknown age with no medical  history reported, who experienced the unexpected event of cardiac disorder. The event occurred on an unknown date and the patient's second dose of Moderna Covid-19 vaccine was also received on an unknown date. The rechallenge is not applicable since no information was provided of the first dose. The benefit-risk relationship of the vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a male subject of unknown age with no medical  history reported, who experienced the unexpected event of cardiac disorder. The event occurred on an unknown date and the patient's second dose of Moderna Covid-19 vaccine was also received on an unknown date. The rechallenge is not applicable since no information was provided of the first dose. The benefit-risk relationship of the vaccine is not affected by this report.
Systemic: Dizziness / Lightheadness-Severe, Additional Details: The patient felt lightheaded after receiving the vaccine but she did not faint. EMS was called and evaluated the patient and she seemed fine. The patient's mother arrived and drove her home.
Fever varying between 99.9-101.9  starting 6 hours post vaccine lasting approximately  36 hours post vaccine. Vomited once approximately 12 hours post vaccine. Mild headache starting 6 hours post vaccine lastly 36 hours. Chills and body aches starting 12 hours post vaccine. General lethargy lasting 36 hours.  48 hours post vaccine felt completely fine with no residual effects
itchy rash; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2018, the patient received the 2nd dose of Shingrix (intramuscular). In January 2019, between 1 and 2 months after receiving Shingrix, the patient experienced itchy rash. The patient was treated with dermatologicals nos (Calamine Lotion). On an unknown date, the outcome of the itchy rash was recovered/resolved.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. In mid December 2018, the patient received Shingrix. In late January 2019, the patient experienced experienced itchy rash around the inside and back of his knees that resolved after a few days and using Calamine lotion. The patient reported that the rash would occur every 2 to 3 weeks between January 2019 and May 2019, but had not recurred since May 2019. The reporter consented to follow up.
rash; had developed shingles after the first dose; This is a spontaneous report from a contactable Health care Professional (Nurse). A 59-year-old female patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced rash and had developed shingles after the first dose on 07Apr2021. It was reported that patient was given Antiviral medication, asked if safe to receive second CoVax. Last dose of antiviral medication will be given 4 days before second COVAX appointment. Therapeutic measures were taken as a result of had developed shingles after the first dose. Outcome of the events was unknown.   Information related to batch/Lot no. was requested.
Received flu vaccine on 9-3-16. Came in on 9-8-16 to report muscle soreness, stiffness, and numbness in arm and finger. Said she could not lift her arm.
Swelling and erythema of the right arm. Mostly on upper arm but some on forearm.
The Medical Assistant reported a temperature excursion for refrigerated vaccine.; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 01-MAR-2021, the patient was vaccinated with an improperly stored dose of hepatitis rotavirus vaccine, live, oral, pentavalent(ROTATEQ) dose 1 (units not provided), per oral route (strength, dose #, frequency, and anatomical location were unknown) with lot # 1691301 and expiration date 12-DEC-2021 for prophylaxis.The patient was asyntomatic.  The administered dose of vaccine experience the temperature excursion on one of these dates, 22-FEB-2021, 25-FEB-2021, 02-MAR-2021, 05-MAR-2021, 09-MAR-2021, 15-MAR-2021, and 19-MAR-2021, of 35.6, 35.7, or 35.9  degrees Fahrenheit for 15 minutes; on 17-MAR-2021, the temperature excursion of 35.7 degrees Fahrenheit for 30 minutes;  on 18-MAR-2021 and 28-MAR-2021, of 35.2 and 35.9 degrees Fahrenheit for 45 minutes; on 25-MAR-2021, of 35.2 degrees Fahrenheit for 4 hours and 15 minutes; on 26-MAR-2021, of 35.4 degrees Fahrenheit for 2 hours and 45 minutes; or on 27-MAR-2021, of 35.9 degrees Fahrenheit 1 hour and 30 minutes.  There was no digital data logger involved, and no previous temperature excursion. The vaccine program did an audit, and they were unaware of the excursions.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA002850: US-009507513-2105USA003496: US-009507513-2105USA003497: US-009507513-2105USA003498: US-009507513-2105USA003499: US-009507513-2105USA003500: US-009507513-2105USA003501: US-009507513-2105USA003502: US-009507513-2105USA003503: US-009507513-2105USA003504: US-009507513-2105USA003505: US-009507513-2105USA003506: US-009507513-2105USA003507: US-009507513-2105USA003508: US-009507513-2105USA003509: US-009507513-2105USA003510: US-009507513-2105USA003511: US-009507513-2105USA003512: US-009507513-2105USA003513: US-009507513-2105USA003514: US-009507513-2105USA003515: US-009507513-2105USA003516: US-009507513-2105USA003517: US-009507513-2105USA003518: US-009507513-2105USA003519: US-009507513-2105USA003520: US-009507513-2105USA003521: US-009507513-2105USA003522: US-009507513-2105USA003523: US-009507513-2105USA003524: US-009507513-2105USA003525: US-009507513-2105USA003526: US-009507513-2105USA003527: US-009507513-2105USA003528: US-009507513-2105USA003529: US-009507513-2105USA003530: US-009507513-2105USA003531: US-009507513-2105USA003532: US-009507513-2105USA003533: US-009507513-2105USA003534: US-009507513-2105USA003535: US-009507513-2105USA003536: US-009507513-2105USA003537: US-009507513-2105USA003538: US-009507513-2105USA003540: US-009507513-2105USA003541: US-009507513-2105USA003542: US-009507513-2105USA003543:
Scattered mild Hives to bilateral antecubital area, with macular rash to upper arms and bilateral upper chest/clavicles.
Bells Palsy on 05/01/2022, treated with steroid over five day period. Loss of hearing, 30%Loss unexplainable irritation to audio nerves and facial disruption.  Covid, contracted twice
Pt did not have an adverse reaction. After injection was completed, error in administration was noted as the incorrect vaccine to give. Mother was notified immediately and is keeping watchful eye over patient. Patient had no previous problems with previous dosed of pediarix.
Patient had booster vaccine on 29-Oct-2021, vaccine had expired on 27-Oct-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient had booster vaccine on 29-Oct-2021, vaccine had expired on 27-Oct-2021) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient had booster vaccine on 29-Oct-2021, vaccine had expired on 27-Oct-2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient had booster vaccine on 29-Oct-2021, vaccine had expired on 27-Oct-2021) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  The vaccine was properly stored.  This case concerns a 74-year-old, male patient with no relevant medical history, who experienced the event expired product administered. The event expired product administered occurred right after the booster dose of mRNA-1273 vaccine administration. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 74-year-old, male patient with no relevant medical history, who experienced the event expired product administered. The event expired product administered occurred right after the booster dose of mRNA-1273 vaccine administration. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This is a spontaneous report from a contactable physician and nurse via Pfizer sales representative. This physician and nurse reported similar events for 6 patients. This is 3rd of 6 reports. An approximate 16-year-old patient received the first dose of TRUMENBA via an unspecified route of administration on an unspecified date at single dose for immunization. The patient experienced rash\hives following first dose of meningococcal group B RLP2086. The symptoms were moderate and resolved after few days. Sender's Comments: Linked Report(s): US-PFIZER INC-2017286355 same reporter/product/event, different patient.
No adverse event; bone marrow transplant patient given 0.25ml as 1st dose for the restart dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (bone marrow transplant patient given 0.25ml as 1st dose for the restart dose) and NO ADVERSE EVENT (No adverse event) 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 Bone marrow transplant in April 2022.    In July 2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In July 2022, the patient experienced INCORRECT DOSE ADMINISTERED (bone marrow transplant patient given 0.25ml as 1st dose for the restart dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (bone marrow transplant patient given 0.25ml as 1st dose for the restart dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (bone marrow transplant patient given 0.25ml as 1st dose for the restart dose).    No concomitant medications were reported.  Reporter stated that a patient had a bone marrow transplant and received the Moderna Covid-19 vaccine at 0.25ml in Jul2022. HCP stated that they need to restart the series in bone marrow transplant patients.  No treatment details were reported.   Reporter did not allow further contact