chrisvoncsefalvay/vaers-outcomes huggingface dataset:
INCORRECT PRODUCT STORAGE; VACCINE GIVEN AFTER A TEMPERATURE EXCURSION COLLECTIVELY FOR 472 HOURS; This spontaneous report received from a health care professional concerned a 41 year old male. 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, batch number: 1855190 expiry: 24/9/2022) dose was not reported, administered on 07-MAR-2022 for covid-19 prophylaxis. The drug was associated with Medication error. Age at time of vaccination 41 years old. No concomitant medications were reported. On 07-MAR-2022, the patient experienced vaccine given after a temperature excursion collectively for 472 hours. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine given after a temperature excursion collectively for 472 hours and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220945831, 20220945933, 20220945957, 20220948245 and 20220948255.
Was feeling good at time of pneumonia vaccine. The day after experienced dyspnea, cough and went to the ER 1/17/17. Was transferred and hospitalized with severe pneumonia. WBC elevated for weeks (30+). Recent echo shows loss of heart function Ejection Fraction decreased to 10%.
Improper storage of product in use; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.      On 17-MAR-2021, the patient was vaccinated with one Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (lot number R036177, which has been verified to be valid, the expiration date was reported and validated as 08-OCT-2021), as prophylaxis (dose, dose number, route of administration, and anatomical site of vaccination were not provided).  The suspect vaccine was exposed to a temperature of 0 hours 30 minutes and 0 seconds (product storage error), as recorded by digital data logger. Additionally, a previous temperature excursion was reported of 46.4 degrees F for a time frame of 0 hours 30 minutes and 0 seconds. The reporter stated all the patients were asymptomatic.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA001297:
General rash from just below shoulder to just above elbow- slight "lump" at injection site.
Per hospital report patient received pediatric dose of Hepatitis A in place of Adult dose of Hepatitis A
Since the date of injection, pt. has had pain in her entire left arm (dull pain).
I had sneezing and coughing and felt like a bad head cold, I had the flu feeling, sore throat and lots of congestion. I saw the doctor the day after I tested positive, I home tested on Sunday and called my doctors office right away and got the medication for the Paxlovid. It got really severe but I think it would have been more severe and longer without the Paxlovid. Someone in the house hold had symptoms a couple days a heard of me and got COVID-19, so I assume I got it from her.
Numb cheek; Left arm was weak; left vision was messed up; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (Numb cheek), MUSCULAR WEAKNESS (Left arm was weak) and VISUAL IMPAIRMENT (left vision was messed up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 13L20X-4) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced HYPOAESTHESIA (Numb cheek), MUSCULAR WEAKNESS (Left arm was weak) and VISUAL IMPAIRMENT (left vision was messed up). On 03-Feb-2021, HYPOAESTHESIA (Numb cheek), MUSCULAR WEAKNESS (Left arm was weak) and VISUAL IMPAIRMENT (left vision was messed up) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact.
Pt came to ER c/o fever, generalized weakness, bilateral leg pain onset 1 day prior.
Patient identifiers obtained; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient identifiers obtained) in a 38-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient identifiers obtained). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient identifiers obtained) 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 did not provide any causality assessments.
feeling body aches after her first dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (feeling body aches after her first dose of the Moderna Covid-19 vaccine) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2022, the patient experienced MYALGIA (feeling body aches after her first dose of the Moderna Covid-19 vaccine). At the time of the report, MYALGIA (feeling body aches after her first dose of the Moderna Covid-19 vaccine) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No concomitant medications were reported.  The patient never went back to receive a second dose of Moderna COVID-19 vaccine. Patient received the vaccine in her left arm shoulder bicep muscle. No treatment details were reported.   Reporter did not allow further contact
Pt vaccinated with ENGERIX-B developed pain aching elbow to shoulder. Raised pimple type area with pus.
After my 2nd dose, I still feel the pain from the injection in my left arm occasionally.; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 41-year-old male patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), administered in left arm, administration date 23Aug2021 (Lot number: unknown) at the age of 41 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. The patient did not take any concomitant medications. Vaccination history included: Covid-19 vaccine manufacture unknown (DOSE 1, SINGLE, Lot Number: UNKNOWN, Anatomical Location: Left arm), administration date: 02Aug2021, when the patient was 41 years old, for COVID-19 immunisation.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 23Aug2021, outcome "not recovered", described as "After my 2nd dose, I still feel the pain from the injection in my left arm occasionally". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Case number PHEH2016US023461, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 24-year-old patient of an unknown gender. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701, expiry date: not reported) at a dose of 0.5 ml intramuscularly on 16 Feb 2016. It was reported that, the patient received FLUVIRIN that had been exposed to 8 to 10 temperature excursion and it was administered to unknown number of patients. No adverse event was reported following this medication error (incorrect product storage).
1) Testicular pain, aching affecting both testicles last 48 hours.  2) Flu like symptoms, aches malaise - no fever.
TIA - stroke occurred one week after second vaccine. Full stroke, loss of intelligent speech, dizzy, out of it, couldn't stand or function, resolved quickly. Required ER visit that day with Stroke Protocol enacted, head scans, etc and follow up the following week at a stroke clinic.
Redness and painful swelling at the injection site within 24 hours. Large itchy circular rash had since developed at the injection site about 6 days later (Covid arm).
Around 8:30 pm started having chills, 10:00 pm had a 101.4 fever, swollen arm, swollen lymph nodes. 8 am the next morning fever was at 99.9. Swelling, swollen lymph nodes, pain when using arm still persist.
Systemic: Patients blood pressure increased directly after receiving injection-Medium, Systemic: Hypertension-Medium, Additional Details: patient said she could tell directly after injection that her blood pressure increased. We monitored at store for 30 minutes. about 15 minutes after receiving her bp was 140/80 pulse 58. 30 minutes post injection she was 157/94. she decided to go home. i asked her to call and update me later in the day. i never heard from her again and we don't have a current phone # on file.
the patient has not had any side effects; a 15 year received PNEUMOVAX 23 by accident; This spontaneous report was received from a nurse concerning a 15-year-old patient. No concurrent condition, medical history, or concomitant therapy was reported.  On 16-DEC-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, dose, frequency, route, lot # and expiration date were unknown) for prophylaxis by accident (accidental exposure to product).  NO other issues or concerns were noted. The patient had not had any side effects at the reporting time.
Abnormal swelling around injection site.  Size of a baseball, hard, itchy and severe redness.  Unable to raise arm above head for several days.  As of today, 9/14 swelling is still prominent and still itchy
Information has been received from a pharmacy student concerning a female patient who in March 2008 ("6 months ago") received a dose of ZOSTAVAX (Merck) (lot number, route and injection site not reported).  On approximately 09-SEP-2008 ("within the past week"), 6 months after the vaccination, the patient developed "a zoster rash on her right side mid-section".  The patient sought medical attention via telephone.  At the time of reporting, she was not recovered from the event.  Follow-up information has been received from a questionnaire concerning the patient, a 79-year-old female who has a history of allergy to penicillin.  She received a dose of ZOSTAVAX (Merck) via subcutaneous route in her right arm on 14-JAN-2008 (previously reported as in March).  No rash occurred  the site of injection or elsewhere within 42 days of the vaccination.  Around 09-SEP-2008, she developed "a zoster rash on her right side mid-section".   Additional information has been requested.
2 severe nosebleeds (have never had a nosebleed in 94 yrs  = first on 27 - second on Mar.3
Vomiting (mild), Headache, Fever, Redness and Induration at site of injection.
Patient came to pharmacy to get his second dose of MMR. Medication was mixed properly but given IM instead of SQ. Patient had no known adverse event. Patient did not stay in store for 15 minutes after shot but called the store later and told a technician he was fine. Technician told him to stay on the phone because pharmacist wanted to speak with him but he hung up. Could not call patient back because he didn't leave his number.
Information has been received from a physician and an other health professional concerning a 49 year old female with chronic obstructive pulmonary disease, hypothyroid, migraines and depression and allergies to codeine, STADOL, morphine, sulfa and LORTAB who on 08-DEC-2006 at 8:30 was vaccinated intramuscularly in the right deltoid with a 0.5 mL second dose of Pneumovax 23 (Lot # 651401/0619F).  On the evening of 08-DEC-2006, the patient experienced pain in the right deltoid, shoulder and upper arm after receiving Pneumovax 23.  The patient sought unspecified medical attention.  The patient was treated prophylactically with KEFLEX 250 mg and DARVOCET for pain.  On 01-JAN-2007, the patient's arm was checked and no symptoms were noted or reported.  No product quality complaint was involved.  Additional information is not expected.
Dizziness, Headache, Myalgia, Pain in left arm around injection site Narrative:
Stabbing pain in both hands, followed by painful pins and needles and numbness both hands and forearms for about 4 days. Dizziness with losses of balance.
Fatigue lasting >24 hours, chills lasting >24 hours, nausea and vomiting lasting 5 hours. Treated with Tylenol.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Shakiness-Severe, Additional Details: pt has fear of needles, has fainted in the past with injections. patient went in and out of conciousness for about 15 seconds and then woke up, 911 was called and paramedics checked all vitals. he said he felt better and did not want to go to hospital wife drove him home.
soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at injection site) in a 73-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness at injection site). At the time of the report, VACCINATION SITE PAIN (soreness at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information were not provided by the reporter. Treatment information were not reported.
Information has been received from a Licensed Practical Nurse, concerning her 15 year old daughter, who in August 2009 "six months ago", was vaccinated with the first dose of GARDASIL (route and lot number not reported). On 10-FEB-2010, the patient was vaccinated with the third dose of GARDASIL (route and lot number not reported). Nurse reported that her daughter experienced a injection site reaction after the product was given. The nurse stated that her daughter had a "raised area that was hard and warm to touch and also looked like a bulls eye rash". The nurse stated that the rash was "almost gone" at the time of reporting. No reactions were reported after the first two doses of GARDASIL. Patient sought unspecified medical attention. Additional information has been requested.
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients; No Adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient 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 11-Jan-2023, 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 EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided    The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients).    No concomitant medications were reported. No treatment medications were reported.  This case contains information for the 68th of 100 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patients post temperature excursion; Poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     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. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome 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 assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    No Concomitant Medication were provided by reporter. No Treatment medication was provided by reporter. This case contains information for the 12th of 104 patient described by the reporter. It was reported that patient received the vaccine after excursion.   This case was linked to MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  MOD-2022-669791:Master case
Patient reports feeling slightly lightheaded. Patient placed on cot with feet elevated x 5 minutes. BP=100/73, P=86, R=18.  Patient reports having 2nd day of menstruation and not eating much for breakfast before work.  Patient reports no food allergies or other health conditions, offered patient saltine crackers and apple juice which patient consumed.  Patient reports symptoms resolved after 10 minutes. Patient requests to leave.
WEAKNESS; NO HIGH BLOOD PRESSURE; RAISED DOTS ON  FACE; RAISED DOTS ON CHEST; FEVER; CHILLS; HEADACHE; RUNNY NOSE; CHEST WARM TO TOUCH; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included heart failure, and sulfa drug, and concurrent conditions included smoker, and influenza. The patient was previously treated with losartan for heart failure, spironolactone for heart failure, metoprolol for heart failure, furosemide for heart failure, and levothyroxine for heart failure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced runny nose. On 09-MAR-2021, the subject experienced chest warm to touch. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021 12:00, the subject experienced raised dots on face. On 09-MAR-2021 12:00, the patient experienced raised dots on chest. On 09-MAR-2021 12:00, the patient experienced fever. On 09-MAR-2021 12:00, the patient experienced chills. On an unspecified date, the patient experienced weakness, and no high blood pressure. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) low (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, chills, and headache, had not recovered from raised dots on face, runny nose, weakness, chest warm to touch, and raised dots on chest, and the outcome of no high blood pressure was not reported. This report was non-serious.
11/7/21 presents to EC ED "with c/o abdominal pain, nausea and non bloody emesis with low grade fever of 100F". PMHx of "AKI, Barrett's esophagus, C difficile, Anxiety, pancreatitis secondary to alcohol abuse, HTN, HLD, and diverticulitis s/p robotic assisted sigmoid resection on 9/27"
Patient is not immunocompromise and was given a 4th Pfizer dose. Patient is fine no adverse reaction.
On October 1, 2020, the patient reported injection site soreness from the day of the vaccination until now. She has an appointment with her primary care physician this week with this chief complaint.
Began Covid-19 symptoms on 6/15/2021 and tested positive for covid-19 on 6/18/2021.
A fever of approximately 101 degrees took place approximately 12-14 hours after receiving vaccine. Fever varied from 99 degrees - 101 degrees for approximately 14 hours. Vomiting took place 3x over the course of the fever. Body aches and chills additionally took place for the duration of the fever. Headache and fatigue have taken place for 24 hours. Arm soreness has additionally taken place for 48 hours.