chrisvoncsefalvay/vaers-outcomes huggingface dataset:
may have already missed the second dose appointment; Right arm sore; Cold; bad sinus of her nose; having a nasal drip, described as her nose is running; symptoms due to pollen; possible soreness when the arm is pressed or rubbed; dose was injected as described by the patient, describing the injection's location as the shoulder,the shoulder blade at the neck, and the right arm; This spontaneous case was reported by a patient and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (dose was injected as described by the patient, describing the injection's location as the shoulder,the shoulder blade at the neck, and the right arm), PRODUCT DOSE OMISSION ISSUE (may have already missed the second dose appointment), PAIN IN EXTREMITY (Right arm sore), NASOPHARYNGITIS (Cold) and SINUS DISORDER (bad sinus of her nose) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (dose was injected as described by the patient, describing the injection's location as the shoulder,the shoulder blade at the neck, and the right arm). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (may have already missed the second dose appointment), PAIN IN EXTREMITY (Right arm sore), NASOPHARYNGITIS (Cold), SINUS DISORDER (bad sinus of her nose), RHINORRHOEA (having a nasal drip, described as her nose is running), SEASONAL ALLERGY (symptoms due to pollen) and VACCINATION SITE PAIN (possible soreness when the arm is pressed or rubbed). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (dose was injected as described by the patient, describing the injection's location as the shoulder,the shoulder blade at the neck, and the right arm), PRODUCT DOSE OMISSION ISSUE (may have already missed the second dose appointment), NASOPHARYNGITIS (Cold), SINUS DISORDER (bad sinus of her nose), RHINORRHOEA (having a nasal drip, described as her nose is running), SEASONAL ALLERGY (symptoms due to pollen) and VACCINATION SITE PAIN (possible soreness when the arm is pressed or rubbed) outcome was unknown and PAIN IN EXTREMITY (Right arm sore) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. The patient states that she used alcohol on the arm for the symptom and was not laying on her right side because of the symptom. She also reports that she has not treated the nasal drip, except by blowing her runny nose. The patient states that she needed assistance in rescheduling her second appointment, as she does not know the exact date for which it was scheduled.
Pt recevied DTaP on 12/10/07 and today came to the office with Right thigh swollen with red/warm demarcated area.Pt was given Atarax and Epson salt soak 15-20 min 3 times per day for 3-5 days
Redness extending from shoulder to elbow and 4-5 inches across which was hot to touch
Pt dev episode of apnea w/cyanosis then noted puffiness of face & tongue somewhat swollen; ER & MD was contacted; admitted placed on apnea monitor & Keflex; Had inc WBC; Hosp x 3 days;
pt recvd vax for prophylaxis;1-1/2 wks later exp rash;to MD;exp also tightness in chest;2 episodes of breathing difficulty/wheezing per pt;adm to hosp;dx acute allergic rxn;c/o weakness over the lower extremities w/ pain over the hips,knees
7/8/99 child seen by MD for well child visit & shots;no illness noted @ time of office visit;child given vax 7/8/99;mom reported child had fever later that day but chose to watch then bring to MD;7/11/99 mom brought child to ER w/fever 106;
Left sided headache, insomnia, paresthesia, scattered, sporadic itching, generalized sense of discomfort.
pt c/o pain in lt shoulder @ site of Td inj; 1 hr p/inj then pt devel fever & h/a & pain worsen;
Tinnitus in both ears. Assessed by ENT. Hearing test shows high frequency hearing loss.
Chalky Taste in Mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Chalky Taste in Mouth) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     no medical history provided by reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced DYSGEUSIA (Chalky Taste in Mouth). At the time of the report, DYSGEUSIA (Chalky Taste in Mouth) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information provided.
injection received 3/31/2021 at 12:55 pm. no event until next morning, noticed spotting, menstrual bleeding. heavy bleeding started 4/2/2021, 12-13 days before any menstruation expected. VERY SEVERE mental health issues, sadness, hopelessness, irritibility that I do not normally experience with PMS normally. I also am extremely regular with my menstruation and have tracked my period for years, and it is always consistent. as of 4/5 still having very heavy bleeding and clotting, some cramping. bleeding is showing no signs of letting up and my period expected start date is around 4/13. I almost didn't want to say anything because it could be chalked up to hormones or stress but this has not happened to me before, and the emotional state I was in was very bad, not even taking into account the bleeding. I am a very pro science and pro data person so I was hesitant to mention anything at all, but feel like IF this is related this could be a huge risk for folks who have a history of depression and anxiety or post partum conditions. The best way I can describe it was deep hopelessness, something I had not felt since having post partum depression when my daughter was born, 7 years ago.
Myalgia & Arthralgia Narrative:  Reports gluteal pain since 12/28/20 #1 dose covid vaccine that has since resolved. Seen in ED 1/21/21 toradol injection administered. 1/25/21 reports lle calf pain u/s done normal findings. Report paresthesia to l foot and has h/o DM II and peripheral neuropathy
Severe chills, sweating lasting 24 hours. Also, my back was covered in itchy bumps that lasted for several days.  Fatigue. No treatment, just went to bed.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 13-MAY-2016, the patient was vaccinated with improperly stored VARIVAX (which had a lot # of L042264 and an expiration date of 26-OCT-2017; however, dose, dosage number, route of administration and anatomical location were not reported). Information regarding concomitant therapies was not provided. The vaccines experienced a temperature excursion of 10 F for a time frame of 3 hours and 16 minutes. Reportedly, no previous temperature excursions had occurred and the aforementioned one was called out due to a data logger. Despite being vaccinated with such an improperly stored vaccine, no adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
unspecified adverse reaction; This spontaneous report has been received from a physician via company representative and refers to the physician's mother-in-law, a female patient of unknown age.      The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On an unknown date (reported as years ago), the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, frequency, route of administration, lot number, and expiration date were not reported) as prophylaxis.         On an unknown date (reported as years ago), the patient had an unspecified adverse reaction. At the reporting time, the outcome of the adverse reaction was unknown.    The causal relationship between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the event was not reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2002USA008023:
LACK OF APPETITE (FORCING HERSELF TO EAT AND DRINK); BODY ACHES; UNABLE TO MOVE (CAN'T GO TO THE  BATHROOM); FEVER; NAUSEA; EXTREME FATIGUE; BAD HEADACHE; This spontaneous report received from a physician concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-OCT-2021, the patient experienced lack of appetite (forcing herself to eat and drink). On 05-OCT-2021, the patient experienced body aches. On 05-OCT-2021, the patient experienced unable to move (can't go to the bathroom). On 05-OCT-2021, the patient experienced fever. On 05-OCT-2021, the patient experienced nausea. On 05-OCT-2021, the patient experienced extreme fatigue. On 05-OCT-2021, the patient experienced bad headache. Laboratory data included: Body temperature (NR: not provided) 104 F, 103 or 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, body aches, nausea, extreme fatigue, bad headache, lack of appetite(forcing herself to eat and drink), and unable to move (can't go to the bathroom). This report was non-serious.
Delivery of moderna vial lot 032B21A at refrigerator temperature, Office was unware that vial was not shipped frozen, staff put vial back into freezer; The dose was given beyound 30days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The dose was given beyound 30days) and PRODUCT TEMPERATURE EXCURSION ISSUE (Delivery of moderna vial lot 032B21A at refrigerator temperature, Office was unware that vial was not shipped frozen, staff put vial back into freezer) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 939906) for COVID-19 vaccination.     It was unknown if patient ever have tested/diagnosed positive for Covid-19. The acute illnesses at time of vaccination or 1 month before vaccination were unknown. Patient did not have chronic or long standing health conditions.  Concurrent medical conditions included Drug allergy.   On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 27-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The dose was given beyound 30days). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Delivery of moderna vial lot 032B21A at refrigerator temperature, Office was unware that vial was not shipped frozen, staff put vial back into freezer). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The dose was given beyound 30days) and PRODUCT TEMPERATURE EXCURSION ISSUE (Delivery of moderna vial lot 032B21A at refrigerator temperature, Office was unware that vial was not shipped frozen, staff put vial back into freezer) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PRODUCT TEMPERATURE EXCURSION ISSUE (Delivery of moderna vial lot 032B21A at refrigerator temperature, Office was unware that vial was not shipped frozen, staff put vial back into freezer) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (The dose was given beyound 30days).    No concomitant medication information was provided. On 16-Jun-2021, moderna vial (lot 032B21A) were delivered at refrigerator temperature.  The reporter stated that the office was unaware that vial was not shipped frozen and staff put vial back into freezer when arrived on morning of 16-Jun-2021. Transport temperature was between 2 to 8 degrees Celsius for couple of hours. Vial was then set out on 27-Aug-2021 to thaw for one hour to room temperature. Dose of 0.5 ml then given to patient on 27-Aug-2021. Per moderna one re-freeze was ok, but can not be given beyond 30 days. This dose was beyond that time.  Patient had no signs or symptoms of any adverse reactions to the injection given. No treatment medication were provided. Patient did not seek medical care. Reporter stated that Moderna can not guarantee that patient received full protection against the covid-19 virus.   This case was linked to MOD-2022-539750 (Patient Link).
States both arms hurt-ache to bones. L arm-flu bruised R arm-Pneumonia warm to touch-pt states knot-none-felt-went to MD.
Patient was confused and was not able to move her feet and could not ambulate, was brought to the ED.
Triangular rash at the injection site the size of her pointing finger; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (Triangular rash at the injection site the size of her pointing finger) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced INJECTION SITE RASH (Triangular rash at the injection site the size of her pointing finger). At the time of the report, INJECTION SITE RASH (Triangular rash at the injection site the size of her pointing finger) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Extreme arm tenderness, unable to raise left arm, sharp pain upon pressing with hard pressure, and lower left arm muscle (deltoid) is hard, but not raised, red, bruised, or hot.
No adverse effects; a patient was administered a dose of improperly stored VARlVAX; Information has been received from a nurse, referring to a patient of unknown age and gender. Information about medical history and concurrent condition was unknown. Concomitant medication included sterile diluent. It could not be determined if the sterile diluent was properly stored.  On 14-OCT-2019, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S015460, expiration date: 20-MAY-2021; dose and strength were unknown) subcutaneously for prophylaxis.  The vaccine was exposed to temperature of -11.5 Celsius degrees for 76 hours. There was no previous temperature excursion. A digital data logger was involved. No adverse effects were reported.
PATIENT RECEIVED PFIZER COVID-19 VACCINE AND UPON STANDING UP, SHE FELL DIRECTLY TO THE FLOOR.
3 Im, 1 sq given, pt went to front desk and mother noticed red area from right arm, MCV 4 given and on other arm, left, SQ where Varicella was given. Both area's looked like child had scratched them child denied any scratching. Vital taken, normal when left. Left with BENADRYL instruct.
This spontaneous report was received from a register nurse, refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. The register nurse informed that on an unknown date the patients received doses of GARDASIL. (Strength, dosage, route, lot# and expiration date were not reported), that were improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Arthralgia, Diarrhea, FATIGUE, CHILLS, WAKING UP SWEATING MULTIPLE TIMES, NASAL CONGESTION AND SORE THROAT Narrative:
Rec'd H1N1 injection, 5 min later with bright red rash like hives on both cheeks extending to both ears.  No swelling.  Benadryl 12.5 mg po given.  Parent left office prior to end of observation period to wait in pharmacy.
Day after vaccine migraine all day with nausea and vomiting. Unable to go to work. Headache for about 2 more days.  8/27/2021 went to the Dr with rash on back and along pantline.
Erythema with streaking. Fever, lymphangitis, adenopathy. Dx: cellulitis. Tx Keflex 500mg bid x 14 days/Tylenol/Motrin.
red rash around COVID moderna injection site and a hard lump appeared a week and a half after injection.
Malaise; This case was reported by a pharmacist via call center representative and described the occurrence of malaise in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced malaise. On an unknown date, the outcome of the malaise was recovered/resolved.   It was unknown if the reporter considered the malaise to be related to Shingrix.  Additional details were reported as follows: The age at the vaccination was not reported. The pharmacist reported that he received a dose of Shingrix and experienced malaise for a couple days afterwards. The case has been linked to the case US2019157513, reported by same reporter.
Patient reported a rash about 8 inches in diameter that felt warm and was sore for about 3-4 days after the shot was given. She did report to her family doctor who recommended BENADRYL and ibuprofen and that the patient wait the full 6 months before getting the second dose in the opposite arm. She did come in on 12/31/18 for her second dose and got it in her right arm. I followed up with her on 1/2/19 and she reported a 2 inch rash but that the pain from the shot was already gone, she had been using BENADRYL and ibuprofen again post shot.
patient received the pfizer bivalent vaccine instead of the primary series for pfizer for his first COVID vaccine. MA incorrectly read the verified the order against the vaccine before giving. no s/sxs following administration error.
Headache, Arthralgia, nasal congestion and runny nose Narrative:  Other Relevant History:
First dose 1 of shingrix in 2019 never got the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No other details of patient / vaccine/ health care professional was provided. The reporter consent to follow up.
Cold feet and toes on both feet, but primarily the right.  Extra layers did not resolve symptom.  Unknown when situation will resolve.
Heart arrhythmias. Weakness. Fatigue. Dizziness Heart pain. Visit to the Emergency Room. Visits to the cardiologists.
Red itchy raised welt at injection site. Welt is gradually receding over time but is still visible one week later. Finger joints on left hand are slightly swollen and sore also.
Due to mal-function of syringe, the dose didn't get in patient's arm instead it went into eyes of; Due to mal-function of syringe, the dose didn't get in patient's arm instead it went into eyes of; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INCORRECT DOSE ADMINISTERED (Due to mal-function of syringe, the dose didn't get in patient's arm instead it went into eyes of) and DEVICE MALFUNCTION (Due to mal-function of syringe, the dose didn't get in patient's arm instead it went into eyes of) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 dosage form. On 30-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Due to mal-function of syringe, the dose didn't get in patient's arm instead it went into eyes of) and DEVICE MALFUNCTION (Due to mal-function of syringe, the dose didn't get in patient's arm instead it went into eyes of). At the time of the report, INCORRECT DOSE ADMINISTERED (Due to mal-function of syringe, the dose didn't get in patient's arm instead it went into eyes of) and DEVICE MALFUNCTION (Due to mal-function of syringe, the dose didn't get in patient's arm instead it went into eyes of) had resolved. Not Provided      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 product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: This report refers to a case of incorrect dose administered, device malfunction for mRNA-1273, lot # 018B21A with no associated AEs.
I started feeling somewhat feverish on Wednesday evening very odd fever, on the following morning I experienced sore throat and headache so I took a home Covid test and it was positive and one hour later I took another home test and it was positive also.
Initial information received on 16-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 12 years old male patient who received 0.5 ml dose of expired vaccine FLUZONE QUADRIVALENT (lot UT5954NA and expiration date 30-Jun-2018) via unknown route in unknown administration site on 15-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used. It was not reported if patients had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
On the evening of day 8  (February 5) I developed one large hive at and proceeding below the vaccination site on my left arm.  It was hot, red, raised, and for the first 12-16 hours, hard to the touch.   It has diminished slightly but is still present this evening, day 13.  Ihave treated it with NSAIDs for the inflammation and sime OTC hydrocortisone cream. I understand this is known as ?COVID arm? and is not serious, but felt you should have the data. I participated in vsafe but that ended before this symptom started.
Moderna COVID-19 Vaccine  Worsening of preexisting pain related conditions (carpal tunnel, tendonitis, back, and knees) in under a 24hr period of receiving the vaccine.  The pain isn't new but every existing pain is more intense.  In regards to my carpal tunnel my hands and fingers feel especially stiff and sore, more so then when I usually have a flair up of pain under normal conditions.