chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer Inc) concerned a 49 year female. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (Codeine). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 24-APR-2021 at right arm for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 48 years old. The concomitant medication included: Allegra, Flonase, lbuprofen started (product name unknown) on 30-APR-2022. The patient also received Moderna covid-19 vaccine (elasomeran) (Dose number in series 2) (form of admin, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, administered on 24-OCT-2021 at left arm for prophylactic vaccination. On 23-JUN-2022, the patient experienced rebound of symptoms started 5 days after ending paxlovid (suspected covid-19 infection) (Dose number in series 2) which resulted to suspected clinical vaccination failure (Dose number in series 1). On 24-JUN-2022, patient received treatment of Albuterol (salbutamol). The patient also took non company suspect paxlovid (form of admin, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, administered from 14-JUN-2022 to 18-JUN-2022 for covid-19 infection.  The action taken with covid-19 vaccine ad26.cov2.s and elasomeran was not applicable and with paxlovid was drug discontinued.  The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0- 20220708748-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. 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: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Moderna Covid-19 vaccine which has undergone multiple temperature excursions.; Moderna Covid-19 vaccine which has undergone multiple temperature excursions; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided. No treatment medication was provided.  It was reported that no adverse reactions or side effects to the Moderna Covid-19 vaccine. It was reported that the vial was moved to refrigerator on 03-Mar-2022.Proposed desired use by date was reported to be on 16-Mar-2022. The temperature excursions occurred on 4-Mar-2022, 5-Mar-2022, 7-Mar-2022, 8-Mar-2022, 9-Mar-2022 and 10-Mar-2022.
Received Tdap 3-6-06 developed severe diarrhea in PM with joint pain, slight fever and malaise, joint pain and malaise lasted 2 days.
Received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 10-year-old patient who received Hepatitis A vaccine (batch number CN3G5) for prophylaxis.   On 10-JAN-2023, the patient received the 2nd dose of Hepatitis A vaccine. On an unknown date, an unknown time after receiving Hepatitis A vaccine, the patient experienced incorrect storage of drug (Verbatim: Received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Rapid heartbeat, lightheaded, sweating, about 5 min duration. Then again 23 hours after vaccination.
Numbness, tingling bilat arms/hands, and continues through 12/6/11 w/toes and lower leg tingling.
Systemic: Fainting / Unresponsive-Medium, Additional Details: vax by  RN, during pts 15 min wait, fainted to the floor, pt attended to, 911 was called, pt was responsive immideately after fainting, pt reported fainting post other vaccines or blood draws. paramedics evaluated pt, pt viatls were normal, pt decided not to go to hospital, followed up with patient at home and indicated he is doing well.
administered Gardasil 9 while being 28 weeks pregnant; mistakenly admonistered gardasil 9 instead of T-DAP; the vaccine hurt; This spontaneous prospective pregnancy report as received from a physician refers to a 31-year-old female patient. The patient's current condition included asthma. The patient had drug allergy due to augmentin (hives). Concomitant therapies included albuterol(ALBUTEROL), budesonide(PULMICORT) and prenatal vitamins (vitamins (unspecified)  On 04-NOV-2019, the patient was mistakenly administered with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # R026716, expiry date: 30-MAY-2021) via intramuscular route for prophylaxis instead of diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (TDAP) (wrong product administered). The patient was 27 weeks pregnant (reported as 28 weeks still pregnant) at the time of vaccination (exposure during pregnancy). The patient became pregnant with last menstrual period (LMP) of 28-APR-2019 and estimated due date (EDD) of 02-FEB-2020. Initial exposure to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was at 27 week(s). The pregnancy outcome was pending. The physician reported that the patient stated that the vaccine was hurting (vaccination site discomfort).  No other adverse effects were reported. It was the first time the patient had vacccine. No additional information. No product quality complaint (PQC).  The outcome of vaccination site discomfort, wrong product administered and exposure during pregnancy was unknown. The reporter considered pain to be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9).
arm started hurting; developed a rash below injection site,; was feeling cold and hot; sweating; nausea; vomiting; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis (in the wrist and hand).   On 5th June 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 6th June 2021, 1 days after receiving Shingrix, the patient experienced pain in arm, rash, feeling hot and cold, sweating, nausea and vomiting. On an unknown date, the outcome of the pain in arm, rash, feeling hot and cold, sweating, nausea and vomiting were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, rash, feeling hot and cold, sweating, nausea and vomiting to be related to Shingrix.  Additional details were provided as follows:  On Saturday, the patient received Shingrix vaccine in right arm and on Sunday the arm started hurting and developed a rash below injection site, was feeling cold and hot, sweating, had nausea and vomiting. The reporter did not consent to follow up.
Warmness and redness further down arm from injection site. Started showing within 48 hours.
Chest to neck rash= allergic reaction; Chest to neck rash= allergic reaction; Turned bright red from chest to halfway up face; face swelled up; 2 hour dry coughing fit resulting in persistent wet cough; tolerable headache; This is a spontaneous report from a contactable consumer. A 45-year-old female patient received Pfizer Covid 19 (BNT162B2) (Batch/Lot number: Unknown, Expiration date: Unknown), on 17Apr2021 at 11Am on left Arm as Dose 1 single for covid 19 immunization. Medical history included TBI (Traumatic Brain Injury) and known allergies: mushrooms and Aspirin from an unknown date. Concomitant medications were not reported. Past drug included Aspirin. On 5Apr2021 at 12 PM Patient experienced Chest to neck rash (allergic reaction), Turned bright red from chest to halfway up face, face swelled up, 12 hour dry coughing fit resulting in persistent wet cough, and tolerable headache. No therapeutic treatments were received. On an unspecified date the outcome of the events was reported as recovering.  Follow-up attempts completed. No further information expected.
Jaw clicks; Lock jaw; Slight pain upon opening her mouth; Arm sore; This spontaneous case was reported by a health care professional and describes the occurrence of JAW CLICKING (Jaw clicks), TRISMUS (Lock jaw), PAIN IN JAW (Slight pain upon opening her mouth) and PAIN IN EXTREMITY (Arm sore) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Thyroid disorder NOS and Fibromyalgia. Concomitant products included AMITRIPTYLINE for Fibromyalgia, AMLODIPINE for Hypertension, VITAMIN C [ASCORBIC ACID] for Immunodeficiency, VITAMIN D NOS for Immunodeficiency NOS, LEVOTHYROXINE for Thyroid disorder NOS.    On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced JAW CLICKING (Jaw clicks), TRISMUS (Lock jaw), PAIN IN JAW (Slight pain upon opening her mouth) and PAIN IN EXTREMITY (Arm sore). On 09-Jan-2021, PAIN IN EXTREMITY (Arm sore) had resolved. At the time of the report, JAW CLICKING (Jaw clicks), TRISMUS (Lock jaw) and PAIN IN JAW (Slight pain upon opening her mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment related information has been reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This case was reported by a other health professional via call center representative and described the occurrence of nausea in a adult patient who received ENGERIX B (batch number XM59T, expiry date unknown). In May 2017, the patient received ENGERIX B. In May 2017, less than a month after receiving ENGERIX B, the patient experienced nausea and vomiting. On an unknown date, the outcome of the nausea and vomiting were unknown. It was unknown if the reporter considered the nausea and vomiting to be related to ENGERIX B. Additional details were reported as follows: The case was received from a medical distributor. The patient was also an employee. The age at vaccination was not reported. This case was 4 of the 5 cases, reported by the same reporter.
Writhing with abdominal pain, one time emeses.  No fever.  Abdominal pain x 3 days on and off. Identical twin sibling with Maple Syrup Urine Disease and no symptoms.
Went to bed at 8:30 pm the night I received the second dose as I was extremely tired (02/25/21).  Woke up at 2:00 am and was a little achy, took 2 Motrin and went back to bed.  Woke up at normal time to go to work and had a little bit of a fever that lasted about two hours.  Very tired the rest of the day (02/26/21).  Symptoms were gone on 02/27/21.
Headache, body ache, fever, soar left arm at injection site, swelling in left underarm with discomfort, swelling of let side of neck with discomfort.
Injection started feeling sore and itchy with visual redness around site. Next day very swollen arm with extreme stabbing pain and numbness in fingers if left arm used. Second day swelling had reduced but redness had spread. Same on day three, redness spread. Started antibiotics on Day three of symptoms after doctor visit.
This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweats), PYREXIA (102F fever), CHILLS (some chills) and MYALGIA (some aches) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Surgery. Concurrent medical conditions included Diabetes. 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, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced HYPERHIDROSIS (sweats), PYREXIA (102F fever), CHILLS (some chills) and MYALGIA (some aches). At the time of the report, HYPERHIDROSIS (sweats), PYREXIA (102F fever), CHILLS (some chills) and MYALGIA (some aches) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102 F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. The concomitant medication was not provided. The treatment information was not provided. This case was linked to MOD-2021-066693.
pt recv vax 9JUN97 & 1997 pt devel itchy rash w/scabs that extended towards elbow;11SEP97 pt hosp & paralyzed on rt side of body & unable to chew, swallow, talk or walk;MRI revealed lesion on lt side of brain near ear & scattered lesions;
Child had swelling of left arm and hives.  No respiratory problems  vital signs same as before shot.  Pulse oximetry good.  Was given Benadryl. Oberved until 2:30 in the office. Had no respiratory symptoms
One hour post vaccination patient developed a rash on forearms and chest area. The rash caused itching. Later in the evening has some swelling about the face and eyes, patient took OTC Benadryl as instructed by her Personal Physician over the phone. Patient took Benadryl PO as directed by Personal Provider and has recovered from event.
Fairly severe aching in the back of neck starting about 10 minutes after receiving 2nd dose. This lasted through the next day when I started experiencing other "normal" side effects, including chills, mild headache, and fatigue.
Patient presented with shakiness/tremors about 15-20 min after receiving first dose of Moderna vaccine. Patient was alert and oriented. Patient representative stated patient does have issues with tremors, but not usually this bad. Patient rep also stated patient had history of heart issues and anxiety. Emergency services were called and patient was taken by ambulance for further evaluation.
This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) in a 71-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) for Rheumatoid arthritis. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and ADALIMUMAB (HUMIRA) (unknown route) 1 dosage form. and ADALIMUMAB (HUMIRA) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm). At the time of the report, PAIN IN EXTREMITY (Pain in arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.
It was reported to us today (7/27) that the patient started experiencing seizures last night.
Seizure, seen in the Emergency Department.  Dr requests to be reported as no other indications for seizure.
The day after injection the patient experienced flu like symptoms with fever, chills, muscle aches and sore injection site. About 30 hours after injection noted a patch of raised red bumpy rash about 2"x2".  Progressed over the next 24 hours, up the left side of his trunk. Raised , red, clustered bumps, slightly moist, tender to the touch. Itchy. Rash totally resolved after a few days.
Neuropathy in vaccinated arm a few minutes after receiving vaccination. Resolved within an hour.
Patient presented to the ED and was subsequently hospitalized for near syncope and AKI within 6 weeks of receiving covid vaccination.
Rash, Itching, Whelps, Redness, Swollen arm
last week i got sick as a dog; Initial information received on 12-Dec-2022 regarding an unsolicited valid  non-serious Social media case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who was diagnosed with last week i got sick as a dog after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer (dose, strength, frequency, formulation, route, batch number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination (immunization).  On an unknown date the patient diagnosed with a non-serious last week i got sick as a dog (illness) (unknown latency) following the administration of influenza vaccine.  It was reported "Since this is a public post on the Sanofi flu shot campaign Flu Shot Fridays we are assuming the consumer is referring to the Sanofi flu vaccine".  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown
A report has been received from a consumer via Health Authority concerning a 48 year old male patient. The patient's concomitant diseases and concomitant medications were not reported. On an unknown date the patient started receiving FLUMIST (intranasal). The patient experienced burning sensation, gait disturbance, limb discomfort, muscular weakness and fatigue. The action taken of FLUMIST was unknown. At the time of reporting, the event of burning sensation, gait disturbance, limb discomfort, muscular weakness and fatigue was ongoing. The events of burning sensation, fatigue, gait disturbance, limb discomfort and muscular weakness were considered as serious with the serious criteria of disability and important medical event by the reporter.
Vaccine 10/10/05. 10/12/05 Cough onset with fevers & chills worsened and persisted chronic and ongoing. Chokes and vomits.
Tested positive for covid. Initially started as allergy type symptoms typical this time of year. Took test just to be sure not covid, but was positive. Feels like I am drowning in mucus, very tight, heavy feeling in chest, coughing, never had a fever, mild chills, headache, blood oxygen levels vary from 94-98. Currently still sick on day 6. Was told to report when someone from VSAFE did a follow up call today.
Patient was inadvertently administed with the 11 days of expired vaccine that was initially stored in the refrigerator on 27 May 2022; Patient was inadvertently administed with the vaccine 11 days after expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was inadvertently administed with the vaccine 11 days after expiration date.) and PRODUCT STORAGE ERROR (Patient was inadvertently administed with the 11 days of expired vaccine that was initially stored in the refrigerator on 27 May 2022) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (primary series.) on 22-Feb-2021 and Pfizer (primary series.). Past adverse reactions to the above products included No adverse reaction with Pfizer and Pfizer.    On 31-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was inadvertently administed with the vaccine 11 days after expiration date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient was inadvertently administed with the 11 days of expired vaccine that was initially stored in the refrigerator on 27 May 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was inadvertently administed with the vaccine 11 days after expiration date.) and PRODUCT STORAGE ERROR (Patient was inadvertently administed with the 11 days of expired vaccine that was initially stored in the refrigerator on 27 May 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  The patient had no known allergies.It was unknown whether the patient had been diagnosed with/ tested positive for COVID 19. Acute and Chronic illness at the time of vaccination and up to one month before was reported as none.  Number of doses/vials administered were reported as one vial and the vial had not undergone any temperature excursions.  No treatment medication were reported.