chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer and described the occurrence of pneumonia in a 69-year-old female patient who received ADVAIR multi dose powder inhaler for allergies. A physician or other health care professional has not verified this report. The patient's past medical history included collapse of lung and lung surgery. Concurrent medical conditions included acid reflux, allergies, histoplasmosis, lung problem and problem breathing. Concurrent medications included Influenza shot, SPIRIVA and Famotidine. In April 2009 the patient started Fluticasone propionate+salmeterol xinafoate (inhaled) at 1 puff(s) daily. On 10 September 2012, the patient experienced pneumonia and cough. This case was assessed as medically serious by GSK. The dose of Fluticasone propionate+salmeterol xinafoate was increased to 1 puff twice daily on 17 September 2012. At the time of reporting, pneumonia was improved and cough was unresolved. This case was also associated with off label use as ADVAIR is not indicated for treatment of allergies. Additional information was provided from a call review by call center of initial call from 14 September 2012. The subject had additional medical history of allergies to ragweed and mold. Chest x-ray was done in the spring of 2012 and "was fine, no changes and lungs were OK." It was reported that the subject started ADVAIR in the spring of 2009. The subject reported that her physician stated that last week she was getting a lot of air in her lungs and she was doing better. She also reported she had an awful cough that the physician said would be for about a week longer. The subject also reported that she "has a cold" (unresolved). Influenza vaccine unspecified (unknown manufacturer) was reported as co-suspect (reported in error as concurrent on first report). In September 2012, the subject was administered Influenza vaccine unspecified (details unknown) and less than a week after vaccination with Influenza vaccine unspecified, the subject experienced the cold, cough and pneumonia. The subject stated that she had the flu shot "just prior" to the events occurring. The subject indicated that the events "may be from the flu vaccine that I just got". It was indicated that the subject had the flu shot "about a week" before the events started.
Complained of chest and throat pain, nausea - No Shortness of Breath; No Hives; Epinephrine 1mg/ml 0.2 ml IM given
Engerix-B second dose 5 months after the first dose/First dose on Dic 30th 2020/Second dose on May 26th 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 22-year-old female patient who received HBV (Engerix B) (batch number P4DJ5, expiry date 15th December 2022) for prophylaxis.   Previously administered products included Engerix B (1st dose received on 30th December 2020).   On 26th May 2021, the patient received the 2nd dose of Engerix B. On 26th May 2021, unknown after receiving Engerix B, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received the 2nd dose of Engerix B five  months after the first dose, which was later than recommended time interval and led to lengthening of the schedule. The pharmacist was looking for guidance on Engerix-B schedule. The reporter consented to follow up.
COVID; Diagnosed with COVID but no symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in a male patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced ASYMPTOMATIC COVID-19 (Diagnosed with COVID but no symptoms). In September 2021, the patient experienced COVID-19 (COVID) (seriousness criterion death). The patient died on an unknown date. The reported cause of death was covid. It is unknown if an autopsy was performed. At the time of death, ASYMPTOMATIC COVID-19 (Diagnosed with COVID but no symptoms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  This case concerns a male patient of an unknown age with no relevant medical history, who experienced the unexpected adverse events of special interest of Asymptomatic COVID-19 and COVID-19. The event occurred on an unknown number of days after receiving an undisclosed dose number of mRNA-1273 Vaccine and had a fatal outcome, with death occurring on an unknown date. The reported cause of death was COVID. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: follow up received has no new information; Sender's Comments: This case concerns a male patient of an unknown age with no relevant medical history, who experienced the unexpected adverse events of special interest of Asymptomatic COVID-19 and COVID-19. The event occurred on an unknown number of days after receiving an undisclosed dose number of mRNA-1273 Vaccine and had a fatal outcome, with death occurring on an unknown date. The reported cause of death was COVID. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Reported Cause(s) of Death: COVID
Pt. had an afebrile generalized tonic-clonic seizure between 48-72 hrs. after administration of MMR, Td & HepB.
within 15 minutes of Pfizer vaccine had itchy arms and facial twitching. She was observed for an hour and was told to take benadryl as needed after leaving. Noticed facial rash later that night. The next day patient was itchy in both arms and has some facial swelling, does not have any trouble breathing. was taking benadryl every 4 hours, seen by allergist next day for telemedicine visit and was advised to switch to cetirizine, max 2 tab bid.
ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 2/23/2023 CANCER METASTATIC TO LIVER ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 2/23/2023 CANCER METASTATIC TO LIVER
Pt recvd 3 doses of Engerix-B 10AMR92 titer rested non-responder;
left arm swelling and redness - about a size of the dime occasional itchiness but no pain or tenderness
fussy, high fever of 103 with Tylenol. that started evening of immunizations. 11/26/19
Patient stated it started with a small, red cluster on the right upper arm and then proceeded to spread to left arm. Rash like appearance on bilateral arms.
sore arm; little fuzzy; little tired; This spontaneous case was reported by a consumer and describes the occurrence of LIMB INJURY (sore arm), FEELING ABNORMAL (little fuzzy) and FATIGUE (little tired) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESTRADIOL and LEVOTHYROXINE for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced LIMB INJURY (sore arm), FEELING ABNORMAL (little fuzzy) and FATIGUE (little tired). On 05-Mar-2021, LIMB INJURY (sore arm), FEELING ABNORMAL (little fuzzy) and FATIGUE (little tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included over the counter allergy pills. No treatment information provided.   This case was linked to MOD-2021-378215, MOD-2021-378216 (Patient Link).
Patient reported to have on the following day after vaccination approximately a 3 inch circular rash on the left hip area with a burning sensation in the hip area and down to the thigh area.
Increase in peripheral neuropathy symptoms: pain, tingling, burning, aching, sharp pains in all 4 limbs.
exposed down to 28 F, administered; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's Comment: The registered pharmacist reported that the patient received a dose of Shingrix vaccine, and which was exposed down to 28 Fahrenheit for 8 hours. The reporter stated that there were no prior excursions. The reporter asked about Shingrix stability and wanted to know any recommendation on revaccination. The reporter was unable to provide any vaccine or patient details at this moment. The reporter did not consent to follow up. Additional supportive information: The patient received a dose of Shingrix vaccine, and which was exposed down to 28 Fahrenheit for 8 hours, which led to incorrect storage of drug. This case was one of 8 cases reported by same reporter.; Sender's Comments:  US-GSK-US2022140236:Same reporter US-GSK-US2022140239:Same reporter US-GSK-US2022140237:Same reporter US-GSK-US2022140235:Same reporter US-GSK-US2022140240:Same reporter US-GSK-US2022140227:Same reporter US-GSK-US2022140234:Same reporter
Vial was expired on 1-Apr-2022 and initially refrigerated on 4-Apr-2022; Expired vaccine administered/ Vaccine was expired on 01 Apr 2022 and was administered on 09 Apr 2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered/ Vaccine was expired on 01 Apr 2022 and was administered on 09 Apr 2022) and PRODUCT STORAGE ERROR (Vial was expired on 1-Apr-2022 and initially refrigerated on 4-Apr-2022) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered/ Vaccine was expired on 01 Apr 2022 and was administered on 09 Apr 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 1-Apr-2022 and initially refrigerated on 4-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered/ Vaccine was expired on 01 Apr 2022 and was administered on 09 Apr 2022) and PRODUCT STORAGE ERROR (Vial was expired on 1-Apr-2022 and initially refrigerated on 4-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that they thought that the vaccine was expired in Jun-2022, however it was expired on 01-Apr-2022 Date the vial was initially stored in refrigerator was 04 Apr 2022. Vial had not undergone any temperature excursion.  Treatment medication was not provided by the reporter.
Patient received smallpox vaccination on 14 Mar 03.  Approx 7 days later he came in to clinic c/o L supraclavicular pain/swelling.  Work up for Virchow's node began w/ CXR and surgery consult for biopsy.  Results back 7 April 2003 and show diagnosis of Reactive Lymphadenitis, probably seconardy to smallpox vaccination.
received Fluarix expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in an unspecified number of patients who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that,  The reporter stated that, between 16 and 17 patients received Fluarix expired dose season 2020-2021, which led to expired vaccine used. The pharmacist needed time to check patients details involved in this situation. The reporter consented to follow up. This case was liked with case US2021AMR201274, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR201274:same reporter
PULMONARY EMBOLISM; BLEEDING AND OTHER SYMPTOMS OF ENDOMETRIOSIS HAD RETURNED; This spontaneous report received from a patient concerned a 40 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: endometriosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown expiry: unknown) dose was not reported, 1 total, administered on 05-APR-2021 for prophylactic vaccination. Non-company suspect drugs included: elagolix sodium (form of admin unknown, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported.  On 2022, bleeding and other symptoms of endometriosis had returned. On 09-FEB-2022, the patient took to hospital via ambulance and diagnosed with pulmonary embolism, and was hospitalized for an unspecified days. Reporter also reported that she had orilissa (elagolix sodium) interaction with blood thinner.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with elagolix sodium was withdrawn. The patient had not recovered from pulmonary embolism and other symptoms of endometriosis had returned was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20220307432-Covid-19 vaccine ad26.cov2.s- Pulmonary embolism. The event(s) has a compatible/ suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Colectomy, Short-bowel syndrome, Condition aggravated"; Colectomy, Short-bowel syndrome, Condition aggravated"; Colectomy, Short-bowel syndrome, Condition aggravated"; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4235970-00 (ABBVIE).  A 69 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 26Sep2021 (Batch/Lot number: unknown) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) at citrate free for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, ROUTE OF ADMINISTRATION: Intramuscular), administration date: 03Mar2021, when the patient was 68 years old, for COVID-19 immunization; Bnt162b2 (Dose:2, ROUTE OF ADMINISTRATION: Intramuscular), administration date: 26Mar2021, when the patient was 69 years old, for COVID-19 immunization. The following information was reported: COLECTOMY (non-serious), SHORT-BOWEL SYNDROME (non-serious), outcome "unknown" and all described as "Colectomy, Short-bowel syndrome, Condition aggravated""; CONDITION AGGRAVATED (non-serious), outcome "not recovered". The action taken for adalimumab was unknown.  Additional information: She was having flare up with her bowels. she had short gut syndromes and pouchiest. The reporter's causality for the event(s) of COLECTOMY, SHORT GUT SYNDROME and FLARE WITH BOWEL was not provided. AbbVie's opinion is that there is no reasonable possibility that the events of COLECTOMY, SHORT GUT SYNDROME and FLARE WITH BOWEL are related to HUMIRA(ADALIMUMAB).  The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the related events and the suspect BNT162B2 cannot be excluded. 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.
Red area, hot to the touch, feels like its burning. Duration: 1 day and getting worse.
Armpit lymph node major swelling; Chills; Fatigue; Difficulty concentrating; Slept poorly; Brain fog; Slight dizziness; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 04May2021 at 11:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included depression, anxiety, foot surgery, blood clotting and penicillin allergy. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration on 13Apr2021 at 11:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04May2021 at 23:00, Chills night of second dose. Slept poorly. Day after until day 11 after left armpit lymph node major swelling. Went away. Brain fog developed shortly after and was present 2weeks later. Fatigue/brain fog/difficultly concentrating/slight dizziness. Therapeutic measures were taken as a result of the events which included treatment with over-the-counter nose spray. The clinical outcome of armpit lymph node major swelling was recovered on an unknown date in May2021. The clinical outcome of the events chills night of second dose. Slept poorly. Brain fog developed shortly after and was present 2weeks later. Fatigue/brain fog/difficultly concentrating/slight dizziness were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Red rash/swelling around right arm 3cm below injection site. Prescribed Keflex 500mg per mouth ever 6 hours for 7 days.
Client has been feeling dizzy for 1 1/2 hours since receiving the vaccination.  BP 140/90 Given water and snack and felt better
pt recv vax 9JAN96 & 26MAR96 & 23APR96 pt devel a rash described as 4 to 5 small papules around anus accompanied by a fever of 103.5;no further details were provided;
Case number PHEH2016US023404 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 46-year-old patient of an unknown gender. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (seasonal influenza vaccine, batch number: 1515701) at a dose of 0.5 ml intramuscularly in the left arm on 12 Jan 2016. It was reported that the patient received FLUVIRIN that had temperature excursion. The patient did not experience any adverse events following vaccination.
Client had received the vaccination and was sitting in the observation area for 15 minutes of post-vaccination monitoring. He was overheard by this RN saying "I feel light-headed" or "I'm feeling dizzy". He was able to walk and was escorted to a private area for monitoring. He lay down on a cot and was given some water to drink. He denied any numbness or tingling around his lips or mouth, any difficulty breathing, or any other sx. At 11:12 am, his BP was 132/78, pulse 85, O2 sat 98%. Client continued to rest and was able to carry on normal conversation. At 11:25 am, vitals again monitored- BP 138/86, pulse 86, O2 sat 99%. Reported dizziness lessened, no new sx. Continued to converse.Sat up on edge of cot for a few minutes, then felt as though he could return to a seat in the observation area. He remained there for approximately 15 more minutes. PHN checked on him one additional time and he reported feeling fine and comfortable leaving on his own.
ACUTE PANCREATITIS; This spontaneous report received from a consumer (wife of the patient) concerned a male of unspecified age, race and ethnic origin.  The patient's height, and weight were not reported. The patient's concurrent conditions included: idiopathic severe acute pancreatitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose was not reported, 1 total administered on 11-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unknown date, the patient had acute pancreatitis. It was suspected that the attack was precipitated by the COVID vaccine and was reported to the Vaccine Adverse Event Reporting System (VAERS) per reporter. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from acute pancreatitis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210936117- covid-19 vaccine ad26.cov2.s-Acute pancreatitis. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
imz was given 8hrs10mins after diution.  pfizer was called to let them know
lip tingling, dizziness, heart racing had hives 24-48 hours after 1st dose
See attached printed visit note. Patient presents with difficulty breathing. It began 1/4 hours ago. It is of moderate intensity. The typical duration of an episode is 10-15 min, after receiving VARIVAX. Associated symptoms include cough, nausea and pallor. Was in office for 2nd VARIVAX today per Dept of Health because his brother was Dx with chickenpox. No reported reaction to first VARIVAX. Received VARIVAX, seemed fine. After 5 min or so, left office. As exiting the building, he told mom he "did not feel good", seemed pale. The c/o difficulty breathing. Mom brought him right back to office. He appeared in distress, and was quickly put in a room and assessment began by RN.
vaccines 12/3. Seen 12/16 with diffuse papules, some blistered, some scars, small 10-20 - neck trunk extremities likely from varivax. Lt lateral thigh swollen, indurated, erythematous, more erythematous around edema approx 2 cm. no papule blister