chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Product temperature excursion issue; expired product administered; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (expired product administered) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (expired product administered). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (expired product administered) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant drugs reported. There was an excursion from their freezer on 01-Oct-2021. They used the excursion tool but there was no option for the excursion they experienced. The tool only gives options for excursions above one hour and not less than, so she does not knowhow to do the analysis. She stated that her team already knows the recommended temperatures and wanted to know if the vials were still okay to be used because they were administered to 118 patients. Concomitant medications were not provided. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-383410 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-383410:MASTER FILE
15 minutes after shot, pt reportedly had muscle stiffening in both arms, became diaphoretic, and was unable to actively contorl his arms.  Had mild shortness of breath, did not lose consciousness, symptoms resolved after 15 minutes.
This spontaneous case, initially received from Merck (reported to Merck by other non-health professional) on 16-Feb-2018, concerning a patient of unspecified age and gender. The patient's medical history and concomitant medication were unknown. On an unspecified date, the patient was administered with influenza vaccine, (anatomical location: arm, dose, route of administration, batch number and expiry date: not reported). On an unspecified date, the patient was administered with non-company suspect product PNEUMOVAX 23 (anatomical location: arm, dose, route of administration, batch number and expiry date: not reported) and Tdap IPV (anatomical location: arm, dose, route of administration, batch number and expiry date: not reported). It was reported that, the patient received Flu vaccine and PNEUMOVAX 23 at different sites in one arm and TDAP in one arm (explicitly coded as drug administered at inappropriate site). On an unspecified date, after vaccination, the patient experienced a rash on the arm at approximately five years ago. At the time of the report, the outcome of the event (injection site rash) was unknown. The reporter assessed the event as non-serious.
Patient had a possible anaphylaxis to FLUZONE. Patient said severe stomach pain and "hard to swallow". Began to try to vomit into trash can. Not much came up. I called 911 and patient was transported to ER.
Received shot on 5/17/2021 at 1:00...Within 20 to 30 minutes upon receiving the Pfizer COVID-19 vaccine, I experienced numbness on the right side of my entire body where the vaccine was given, also and pressure behind my right eye. Along with tingling on the right side of my body, headache, fatigue.  Called pharmacy and was advised by a man that it?s fairly common and that it would go away in 24-48 hours and if it didn?t then to seek medical care.   As of 12:40AM on 05/22/2021 it is better but still not back to fully 100%.  It is now been 4 days going on 5 and I still have loss of sensation on the right side of my body of approximately 5% (tingling).  Have not taken anything nor sought medical care. Even thought a visit to the ER was recommended, Patient said he could still mostly function.
Received vaccine after temperature excursion; Received vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Received vaccine after temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Received vaccine after temperature excursion) in a 26-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Received vaccine after temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Received vaccine after temperature excursion). On 18-Mar-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Received vaccine after temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Received vaccine after temperature excursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Started with a fever at 8:00 PM after receiving H1N1 vaccine at 3:00 PM. Also had severe body aches, headache and sore throat.  The headache and body aches has continued as of this time.  Has treated with Advil/Tylenol at the OTC doses.
10 minutes after injection in my left arm The right side of my face felt numb and was tingling. It felt like my right eye was swollen ( which it didn?t appear to be) also the numbness extended to my jaw Lasted about 15 minutes then slowly went away
Horrible headache, unable to sleep and headache next day.  Arm sore...expected that.  Could be hypothyroidism.
UNBEARABLE HEAD POUNDING; NAUSEA; VOMITING; LOW FEVER; FATIGUE; This spontaneous report received from a patient concerned a 61 year old  adult female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: unknown) dose was not reported, administered on 23-MAR-2021 14:37:00 for prophylactic vaccination. No concomitant medications were reported.  On 25-MAR-2021, the subject experienced fatigue. On 27-MAR-2021, the subject experienced low fever. 100 F. On 02-APR-2021, the patient woke up at 3am with unbearable head pounding for which the patient took 2 acetaminophen even after 15 min there was no relief so she took small amount of codeine around (1/3 of a 15mg tab) after 5-10 min the patient threw both meds and experienced nausea for which she took anti-nausea tab under her tongue but that did not released her nausea. The Patient could not take her medication due to nausea and vomiting.  At 10:30 am one of her family member took her to  Hospital in  and performed CT (computerized tomography) scan and PET (positron emission tomography) scan which are normal The Patient was hospitalized for 5 hours and received IV of a steroid (unspecified), Benadryl, anti-nausea (unspecified) and (unspecified) pain medication as a treatment CT scan and PET scan was normal based on which Doctor concluded that the side effects are due to J and J vaccine. Treatment medications included: codeine, diphenhydramine hydrochloride, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from unbearable head pounding, nausea, and vomiting on 02-APR-2021, fatigue on 26-MAR-2021, and low fever on 27-MAR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210452159-COVID-19 VACCINE AD26.COV2.S-headache. This event(s) is labeled per RSI and is therefore considered potentially related. 20210452159-COVID-19 VACCINE AD26.COV2.S-vomiting. This event(s) is considered not related. The event(s) has an unknown/unclear 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: CONMEDS-OTHER SUSPECT DRUGS
Initial misuse report received from a healthcare professional on 06 June 2013. An 11-year-old patient was given DAPTACEL instead of ADACEL. No adverse event was reported. List of documents held by sender: None
This case was reported by a pharmacist and described the occurrence of extra dose administered in a patient who received INFANRIX. Co-suspect products included BOOSTRIX. Concomitant products included INFANRIX. On an unknown date, the patient received INFANRIX at an unknown dose and BOOSTRIX at an unknown dose. On an unknown date, an unknown time after receiving INFANRIX and BOOSTRIX, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. Additional information: The pharmacist did not have any patient information. The patient has not experienced any adverse event yet. But an adult patient got a dose of INFANRIX from the clinic and later on the same day got a dose of BOOSTRIX or INFANRIX from the primary provider.
Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm pain). At the time of the report, PAIN IN EXTREMITY (Arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment medication was not provided by the reporter.
This spontaneous report as received from a pharmacist refers to a 60 year old female patient with asthma and hypercholesterolemia. No known allergies were reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (route of administration, dose, lot number, anatomical location was unknown). Concomitant medications were unspecified by reporter. The reporter stated that on an unknown date the patient had an injection site reaction, the patient's injection site was red and slightly swollen. She was also experiencing numbness in her hand and fingers. The patient was advised to take acetaminophen as needed. The outcome of the events was reported as not recovered/not resolved. The causality was unknown. No further information was provided. Additional information has been requested.
Syncope and fell on her hands and knees. No head trauma. No other injuries. BP 110/77, 85, O2 sat 96%. She was observed for 35 minutes. She felt better and went home.
patients that were vaccinated with this vaccine after the excursion; No adverse event; patients that were vaccinated with this vaccine after the excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion), POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event) in a 55-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension, Sleep apnea and Anxiety.    On 04-Oct-2022 at 1:30 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 04-Oct-2022 at 1:30 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion), POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion).    Concomitant products were not reported.  It was reported that moderna bivalent vaccine was administered after a temperature excursion. Patient did not reported any adverse events. Vaccine was not viable. It was unknown if the patient was ever diagnosed with or tested positive for Covid 19.   Treatment medications were not reported.
Child has had repeated episodes of rash with all vaccines 24-48 hr after vaccine again. Mother reported this to MD on 2/5/16.
Information has been received from a female patient who was a medical assistant and a physician concerning the patient who was vaccinated with her first dose of GARDASIL (lot number not available) on an unspecified date. Subsequently the patient developed a stiff neck after receiving the first dose of GARDASIL on an unspecified date. She recovered 3 days after injection. The patient sought unspecified medical attention. Follow up information was received from the 21 year old patient (medical assistant) who was vaccinated with her first dose of GARDASIL (lot #660616/0570X) on 18-FEB-2009. There were no concomitant vaccines or medications. She had no pertinent medical history other than an allergy to penicillin. The AE onset date was 19-FEB-2009. The condition was not disabling. According to the patient, she wasn't sure if the event had anything to do with the vaccine and indicated that she could have just slept wrong. The patient was planning on receiving her second dose of GARDASIL in April 2009 and would report if she again experienced a stiff neck. Additional information has been requested.
Headache, chills, body aches,  fever for over 24 hours, fatigue
Soreness in throat; Headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Soreness in throat) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ATORVASTATIN CALCIUM (LIPITOR) and GLIPIZIDE for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Soreness in throat) and HEADACHE (Headache). On 15-Jan-2021, OROPHARYNGEAL PAIN (Soreness in throat) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was provided.  No medical history information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: No new information.
Numbness in right pinky finger 20 minutes following injection. Within 50 minutes, experienced numbness in right hand all the way up to right elbow. Intermittent tingling present. Numbness continued consistently for 2 hours following vaccine administration, and was intermittent for the rest of the day. No numbness or tingling the following day 6/15.
Cancer; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (Cancer) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (Cancer) (seriousness criteria death and medically significant). The reported cause of death was Cancer. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NEOPLASM MALIGNANT (Cancer) to be related.    No concomitant medication was reported. Suspect product dosage text was reported as unknown. It was reported that cancer rates for jabbed Moderna Cancer patients was up 300 percent. No treatment medication was reported. This case contains information about 16th patient out of 25 patients.  Company comment:  This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the Fatal serious (due to medically significant) unexpected, event of Neoplasm malignant, which occurred after the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as part of COVID-19 vaccination schedule, dose number not provided. The patient died on an unknown date, and it is unknown whether an autopsy was performed. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-735987 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735987:Master case; Reported Cause(s) of Death: Cancer
On 3/23 I had maderna, on 4/24 the pharmacy gave me wrong 2nd does. They gave me Pfizer. They made an error. I am concerned because they have not contacted me with follow up info. I don?t know what to do.  Can you help me.
Post vaccine, a few hours later he had symptoms of an upper respiratory infection.  It evolved into a fairly intense headache for which he took some ibuprofen.  He had chills and fevers and felt very poorly.  At 7 AM on Saturday, April 24 he suffered excruciating substernal chest pain.  It was a burning sensation and it was so severe he wanted to die to relieve the pain. The pain was only minimally positional and it was nonpleuritic. He drove himself to the nearest hospital and even drove through some red lights to get there more quickly.  When he arrived he had ST elevation in the same leads with his early repolarization which was perhaps a millimeter or so higher than the EKG we did in February.  He had both an elevation of his troponin levels which were 5.07, 6.06, 5.72 and 5.73.  A CK was 195 with an MB of 41.2.  He was taken to the cath lab emergently.  no coronary disease.
this is one of two pt from this site to devel a 4 to 6inch area of swelling @ inj site immed p/vax;addtl info was recv 13NOV96;pt also devel a 6inch area of redness, hardness, & warmth @ inj site;pt recovered;
after vaccination, the staff realized that this patient was only 19 days post first vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (after vaccination, the staff realized that this patient was only 19 days post first vaccine) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (after vaccination, the staff realized that this patient was only 19 days post first vaccine). On 06-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (after vaccination, the staff realized that this patient was only 19 days post first vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
6 hours after vaccine: fever to 100.6, fatigue, body aches . Persisted through next day and evening. Resolved by 36h. Around 50 hours, son complaining of leg pain bilaterally causing difficult walking with suspected myositis (similar episode 2 years ago). Resolved in about 12 hours.
A couple hours after receiving the vaccine the patient's arm was swelling, red, hard, and hot. 7 days  after receiving the vaccine her arm was still itchy, blotchy, and red.
Information has been received from a nurse referring to five patients of unknown age and gender. The patients' pertinent medical history and concurrent condition were not reported. On unknown dates the patients were vaccinated with doses of improperly stored (Oka-Merck) PROQUAD (lot # L005293 with expiration date of 17-AUG-2016, dose, strength and route unknown). No adverse effects reported. Additional information has been requested.
My wife walked with a cane for three months after her last booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunisation. The following information was reported: GAIT DISTURBANCE (disability), outcome "unknown", described as "My wife walked with a cane for three months after her last booster".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Redness and heat on the right arm, 4 days. Shivering, achiness in muscles and joints, fatigue.
no additional AE details available; Improperly stored vaccine administered / temperature above 46F (62.8F); This spontaneous report was received from an unspecified reporter and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions or concomitant therapies were not reported.  On 07-SEP-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #1879864, expiration date: 19-OCT-2023; route of administration defaulted to oral, dose was not reported), that was improperly stored.  Storage and temperature excursion details: Temperature: above 46 degrees Fahrenheit (62.8 degrees Fahrenheit) Time frame: 8 hours 0 minutes and 0 seconds Previous temperature excursion? No  No additional adverse event (AE) details available.