chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Suspected COVID-19
Clinical narrative: REVACCINATION WITH DIFFERENT COVID-19 VACCINE; GOT COVID; This spontaneous report received from a consumer through social media, via a company representative concerned a 96-year-old female of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient had previously received two doses of covid-19 vaccine (unspecified manufacturer) (dose number in series 1) (form of admin, route of admin and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported was administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine (unspecified manufacturer) (dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (unspecified manufacturer) (suspension for injection, route of admin and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 total was administered for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 2). The batch number was not reported. Per procedure, no follow-up will be requested for this case. Age at time of vaccination 10 decade old. No concomitant medications were reported. On an unspecified date in DEC-2022, the patient got covid (suspected covid-19 infection) and was really sick (dose number in series 2). It was reported as, "My mom 96, got Covid had all shots and boosters, and she is really sick. Scared for her". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the got covid and revaccination with different covid-19 vaccine was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000264968.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Decreased appetite, Oral discomfort, Paraesthesia oral
Clinical narrative: TINGLING AROUND LIPS (CERTAIN THINGS INTENSIFIES IT LIKE CERTAIN COLOGNES, FOOD, TERMITE SPRAY); BURNING SENSATION  ALL THE WAY AROUND LIPS AND ON TONGUE (HAD NO BLISTERS AND NO PHYSICAL SIGNS); NUMEROUS CHEST BRONCHITIS (AND RELATED BREATHING PROBLEMS); COULD NOT EAT ANYTHING; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included: 2 sinus infections, and concurrent conditions included: seasonal springtime allergies (As she got older, it got better.), asthma (As a child, had asthma.), and periodically had bronchitis (once or twice a year). The patient was previously treated with fluticasone propionate for seasonal springtime allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 67 years old. No concomitant medications were reported. On APR-2021, the patient experienced burning sensation all the way around lips and on tongue (had no blisters and no physical signs). On APR-2021, the patient experienced numerous chest bronchitis (and related breathing problems). On APR-2021, the patient experienced could not eat anything. On an unspecified date, the patient experienced tingling around lips (certain things intensifies it like certain colognes, food, termite spray). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not eat anything, had not recovered from tingling around lips (certain things intensifies it like certain colognes, food, termite spray), and the outcome of burning sensation all the way around lips and on tongue (had no blisters and no physical signs) and numerous chest bronchitis (and related breathing problems) was not reported. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Peripheral swelling, Physical examination, Scan
Clinical narrative: SWELLING BELOW ELBOW (LOWER ONE); SWELLING IN UPPER ARM (AROUND WHERE THE VACCINE WAS GIVEN); This spontaneous report received from a patient concerned a 66-year-old female. The patient's weight was 168 pounds, and height was 64 inches. The patient's concurrent conditions included: hypertension, drug allergy (Chloroquine), non-smoker, and non-alcohol user, and other pre-existing medical conditions included: There was no drug abuse or illicit drug usage for patient. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, 1 total administered on 04-APR-2021 to left arm for covid-19 prophylaxis. The product was stored in appropriate temperature conditions and was it properly stored from receipt to administration. Age at time of vaccination 66 years old. Patient takes blood pressure medication and supplements. On 16-APR-2021, the patient experienced swelling below elbow (lower one) and swelling in upper arm (around where the vaccine was given) and she called her primary care physician, and who asked her to go to the emergency room (Dose number in series 1). On 17-APR-2022, patient went to hospital (emergency room) where test was conducted, Laboratory data included: Physical examination which showed patient did not have any blood clot, and Scan (scanned left arm) showed patient did not have any blood clot. The patient reported the swelling was still a little bit there, the upper one and the lower one disappeared after some time. On 10-DEC-2021, the patient received booster dose with Pfizer Biontech Covid-19 Vaccine (tozinameran), (Dose number in series 2), (form of admin, route of admin, and batch number and expiry date were not reported) dose was not reported, administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling below elbow (lower one) and was recovering from swelling in upper arm (around where the vaccine was given). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: GOING TO DIE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis.  It was unknown whether the patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced going to die (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of going to die was not reported. This report was non-serious.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Feeling hot, Rash, Urticaria
Clinical narrative: clothes that make me warm or hot; small rash all along the axillary border that appeared very inflamed; hives/broke out in whelps under my armpits that hurt and itched a lot; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (clothes that make me warm or hot), RASH (small rash all along the axillary border that appeared very inflamed) and URTICARIA (hives/broke out in whelps under my armpits that hurt and itched a lot) in a 65-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no.) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: ARMOUR THYROID. Past adverse reactions to the above products included Thyroid disorder with ARMOUR THYROID. Concurrent medical conditions included Hashimoto's thyroiditis.    On 13-Oct-2022, 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 05-Nov-2022, the patient experienced RASH (small rash all along the axillary border that appeared very inflamed) and URTICARIA (hives/broke out in whelps under my armpits that hurt and itched a lot). On an unknown date, the patient experienced FEELING HOT (clothes that make me warm or hot). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, FEELING HOT (clothes that make me warm or hot) outcome was unknown and RASH (small rash all along the axillary border that appeared very inflamed) and URTICARIA (hives/broke out in whelps under my armpits that hurt and itched a lot) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported patient receive any other vaccines in the 4 weeks prior to COVID-19. About 3 weeks later, approximately 05-Nov-2022, patient broke out in helps under armpits that hurt and itched a lot. It soon developed into a small rash all along the axillary border that appeared very inflamed. It was somewhat better there as it was intermittent, but it was all over patient torso, anterior and posterior. It gets worse if patient had on clothes that make warm or hot. Patient had never had hives before and patient very healthy 65-year-old. Patient did not had symptoms of Hypothyroid with the medication and had again never had hives.  It was very uncomfortable and only controlled somewhat with antihistamines and topical hydrocortisone ointment or cream   This case was linked to US-MODERNATX, INC.-MOD-2022-693148 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-693148:case (reporter)
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: husband received only 1st shot of the Moderna COVID19 vaccine Vaccination Provider told the patient that the second dose was not available at the moment; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (husband received only 1st shot of the Moderna COVID19 vaccine Vaccination Provider told the patient that the second dose was not available at the moment) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (husband received only 1st shot of the Moderna COVID19 vaccine Vaccination Provider told the patient that the second dose was not available at the moment) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (husband received only 1st shot of the Moderna COVID19 vaccine Vaccination Provider told the patient that the second dose was not available at the moment) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (husband received only 1st shot of the Moderna COVID19 vaccine Vaccination Provider told the patient that the second dose was not available at the moment).    It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller's husband received only 1st shot of the Moderna COVID19 vaccine  Vaccination Provider told the patient that the second dose was not available at the moment agent provided information from Vaccines org . Concomitant medications were not reported.  No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No Adverse Event; bivalent was given in the 0.3 ml instead of the 0.5 ml to a patient; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (bivalent was given in the 0.3 ml instead of the 0.5 ml to a patient) and NO ADVERSE EVENT (No Adverse Event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .3 milliliter. On 28-Dec-2022, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced UNDERDOSE (bivalent was given in the 0.3 ml instead of the 0.5 ml to a patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, UNDERDOSE (bivalent was given in the 0.3 ml instead of the 0.5 ml to a patient) 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 assessment was provided for UNDERDOSE (bivalent was given in the 0.3 ml instead of the 0.5 ml to a patient).    No concomitant drug information was provided. It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine. No treatment drug information was provided.
Sex: M
Vaccine: COVID19-2
Symptoms: Death
Clinical narrative: found dead; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (found dead) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetic.    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. Death occurred on an unknown date The cause of death was not reported. 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 did not provide any causality assessments.   Concomitant medication was not reported. Patient got the booster shot found dead in the morning. Treatment drug was not reported.  Company comment: This is a spontaneous case regarding a male patient of an unknown age, with concurrent medical condition of diabetes, who died after receiving mRNA-1273.222 bivalent vaccine (Original/Omicron BA.4/5). The event Death  (seriousness criteria death and medically significant) occurred on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. According to the report, patient received the booster shot and was found dead in the morning. No further details were disclosed. Concurrent medical condition of diabetes remains a confounding factor. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-692839 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case regarding a male patient of an unknown age, with concurrent medical condition of diabetes, who died after receiving mRNA-1273.222 bivalent vaccine (Original/Omicron BA.4/5). The event Death  (seriousness criteria death and medically significant) occurred on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. According to the report, patient received the booster shot and was found dead in the morning. No further details were disclosed. Concurrent medical condition of diabetes remains a confounding factor. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-692839:Master case; Reported Cause(s) of Death: unknown cause of death
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: covid symptoms, sneezing, coughing, more mucous, nausea, malaise, more respiratory problems,results confirmed that he had Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid symptoms, sneezing, coughing, more mucous, nausea, malaise, more respiratory problems,results confirmed that he had Covid) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     The patient's past medical history included Dental surgery NOS on 29-Dec-2022.    On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022,  after starting , the patient experienced COVID-19 (covid symptoms, sneezing, coughing, more mucous, nausea, malaise, more respiratory problems,results confirmed that he had Covid). At the time of the report, COVID-19 (covid symptoms, sneezing, coughing, more mucous, nausea, malaise, more respiratory problems,results confirmed that he had Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2022, SARS-CoV-2 test: (Positive) Covid test on10-Jan-2022, and results confirmed that he had Covid on Tuesday, 11-Jan-2022..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: administered with a 2nd dose of the COVID-19 Vaccine Bivalent on 29Dec2022. HCP mentioned the 1st dose of the bivalent was given on 22Sep2022; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (administered with a 2nd dose of the COVID-19 Vaccine Bivalent on 29Dec2022. HCP mentioned the 1st dose of the bivalent was given on 22Sep2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown 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 22-Sep-2022, 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 29-Dec-2022, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .5 milliliter. On 29-Dec-2022, the patient experienced EXTRA DOSE ADMINISTERED (administered with a 2nd dose of the COVID-19 Vaccine Bivalent on 29Dec2022. HCP mentioned the 1st dose of the bivalent was given on 22Sep2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (administered with a 2nd dose of the COVID-19 Vaccine Bivalent on 29Dec2022. HCP mentioned the 1st dose of the bivalent was given on 22Sep2022) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (administered with a 2nd dose of the COVID-19 Vaccine Bivalent on 29Dec2022. HCP mentioned the 1st dose of the bivalent was given on 22Sep2022).    Patient was inadvertently administered with a 2nd dose of the COVID-19 Vaccine Bivalent on 29-Dec-2022.  HCP mentioned the 1st dose of the bivalent was given on 22-Sep-2022.  HCP mentioned patient did not reported any adverse event after the vaccine was given.  It was unknown if patient experienced any adverse event after previous doses of the vaccine. No concomitant medications were reported. No treatment medications were reported.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; only had the Moderna Bivalent vaccine at the time and administered it on 22Nov2022; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (only had the Moderna Bivalent vaccine at the time and administered it on 22Nov2022) and NO ADVERSE EVENT (No adverse event) in a 32-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On 22-Nov-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Nov-2022, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (only had the Moderna Bivalent vaccine at the time and administered it on 22Nov2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (only had the Moderna Bivalent vaccine at the time and administered it on 22Nov2022) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (only had the Moderna Bivalent vaccine at the time and administered it on 22Nov2022).    Concomitant medications were not reported.                                       No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 3 doses of primary series vaccine administered after the 30 day beyond use date.; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 doses of primary series vaccine administered after the 30 day beyond use date.) and NO ADVERSE EVENT (No Adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 doses of primary series vaccine administered after the 30 day beyond use date.) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 doses of primary series vaccine administered after the 30 day beyond use date.) had not resolved 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (3 doses of primary series vaccine administered after the 30 day beyond use date.).    No concomitant medication was reported. No treatment medication was reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Gait inability, Limb discomfort
Clinical narrative: I can't walk, I can't put weight on it/left leg went out /I went down to the floor/I walk with a limp/I am wrapped up now with a belt and support hose just so I can try to walk/have support hose coming up my leg/ I'm walking with a I stick here; it messed up my left thigh, from my knees, back of my knees to hip; I got left belts wrapped around my thighs just so I can stand up; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (I can't walk, I can't put weight on it/left leg went out /I went down to the floor/I walk with a limp/I am wrapped up now with a belt and support hose just so I can try to walk/have support hose coming up my leg/ I'm walking with a I stick here), LIMB DISCOMFORT (it messed up my left thigh, from my knees, back of my knees to hip) and DYSSTASIA (I got left belts wrapped around my thighs just so I can stand up) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 prophylaxis.     Patient had no COVID diagnosis.  Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (Lot: 050E21A.) on 08-Oct-2021. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE. Concurrent medical conditions included Allergy and Blood pressure high (Patient was taking blood pressure medicines.).    On 14-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT INABILITY (I can't walk, I can't put weight on it/left leg went out /I went down to the floor/I walk with a limp/I am wrapped up now with a belt and support hose just so I can try to walk/have support hose coming up my leg/ I'm walking with a I stick here), LIMB DISCOMFORT (it messed up my left thigh, from my knees, back of my knees to hip) and DYSSTASIA (I got left belts wrapped around my thighs just so I can stand up). At the time of the report, GAIT INABILITY (I can't walk, I can't put weight on it/left leg went out /I went down to the floor/I walk with a limp/I am wrapped up now with a belt and support hose just so I can try to walk/have support hose coming up my leg/ I'm walking with a I stick here), LIMB DISCOMFORT (it messed up my left thigh, from my knees, back of my knees to hip) and DYSSTASIA (I got left belts wrapped around my thighs just so I can stand up) 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.   It was reported that patient was taking blood pressure medicines.  No treatment medication was provided.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Pharmacist is calling to report that 2 adult patients received Expired Bivalent booster beyond 12 hours post puncture.Dose administered >12(US) hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that 2 adult patients received Expired Bivalent booster beyond 12 hours post puncture.Dose administered >12(US) hours post puncture) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Dec-2022, 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 28-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that 2 adult patients received Expired Bivalent booster beyond 12 hours post puncture.Dose administered >12(US) hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that 2 adult patients received Expired Bivalent booster beyond 12 hours post puncture.Dose administered >12(US) hours post puncture) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that 2 adult patients received Expired Bivalent booster beyond 12 hours post puncture.Dose administered &gt;12(US) hours post puncture).    Concomitant product use was not provided by the reporter.  On 21-Dec-2022 2.5 ml vials were initially stored in the refrigerator.  On 27-Dec-2022 at 2:30 P.M, vial was first punctured.  On 28-Dec-2022 11:30 A.M vaccine was administered  Vial was exposed to room temperature (8° to 25°C or 46° to 77°F) for 21 hours.  Vial did not undergo any temperature excursions.  Treatment information was not provided.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-693180:Master case (patient 1 of 1)
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Myalgia, Nausea
Clinical narrative: Patient cannot eat or drink water; body aches; nausea / sick to stomach; This spontaneous case was reported by a patient and describes the occurrence of FEEDING DISORDER (Patient cannot eat or drink water), MYALGIA (body aches) and NAUSEA (nausea / sick to stomach) in a 91-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 2, Primary Series), PFIZER BIONTECH COVID-19 VACCINE (Dose 1 and Primary Series). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 28-Dec-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Dec-2022, the patient experienced FEEDING DISORDER (Patient cannot eat or drink water), MYALGIA (body aches) and NAUSEA (nausea / sick to stomach). At the time of the report, FEEDING DISORDER (Patient cannot eat or drink water), MYALGIA (body aches) and NAUSEA (nausea / sick to stomach) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Patient had received her first Moderna Covid-19 booster dose as the bivalent dose.  It was reported that patient had not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient reported that she then needed to end the interview as she wanted to call a Pharmacy associated with her Pharmacy.   Treatment medication was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in refrigerator on 01-Nov-2022 and was administered after 30 day use by date; No adverse event; received doses from the same lot number #015h22a administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received doses from the same lot number #015h22a administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 01-Nov-2022 and was administered after 30 day use by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015h22a) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, 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. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received doses from the same lot number #015h22a administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 01-Nov-2022 and was administered after 30 day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received doses from the same lot number #015h22a administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 01-Nov-2022 and was administered after 30 day use by date) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (received doses from the same lot number #015h22a administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 01-Nov-2022 and was administered after 30 day use by date).    No concomitant medications were reported.   The vial size reported was 2.5 milliliter. The vial was initially stored in refrigerator on 01-Nov-2022. The vial did not undergo any temperature excursion.   No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-693246, US-MODERNATX, INC.-MOD-2022-693247, US-MODERNATX, INC.-MOD-2022-693248, US-MODERNATX, INC.-MOD-2022-693249, US-MODERNATX, INC.-MOD-2022-693250 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-693249:Original Case : MOD-2022-692559 US-MODERNATX, INC.-MOD-2022-693248:Original Case : MOD-2022-692559 US-MODERNATX, INC.-MOD-2022-693247:Original Case : MOD-2022-692559 US-MODERNATX, INC.-MOD-2022-693250:Original Case : MOD-2022-692559 US-MODERNATX, INC.-MOD-2022-693246:Original Case : MOD-2022-692559
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Vaccination error
Clinical narrative: No Adverse event; the patient has had 2 Pfizer doses, 2 primary Moderna Monovalent 0.5 mL doses that clinic administered; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION ERROR (the patient has had 2 Pfizer doses, 2 primary Moderna Monovalent 0.5 mL doses that clinic administered) and NO ADVERSE EVENT (No Adverse event) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 053C21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (dose 1) on 22-Apr-2021 and PFIZER BIONTECH COVID-19 VACCINE (dose 2) on 18-May-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.   On 15-Jun-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Jul-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 15-Jun-2021, the patient experienced VACCINATION ERROR (the patient has had 2 Pfizer doses, 2 primary Moderna Monovalent 0.5 mL doses that clinic administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, VACCINATION ERROR (the patient has had 2 Pfizer doses, 2 primary Moderna Monovalent 0.5 mL doses that clinic 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 assessment was provided for VACCINATION ERROR (the patient has had 2 Pfizer doses, 2 primary Moderna Monovalent 0.5 mL doses that clinic administered).    It was reported that Pfizer was administered as dose 5 after the 2 Moderna doses on 2-Dec-2021. No concomitant medications was reported.  It was unknown whether patient received any other vaccines in 4 weeks prior to COVID-19 vaccine. Certified Medical Assistant reported that a patient informed that she hadn't received any previous vaccines, so clinic administered 2 Moderna primary doses to the patient. Upon review of vaccine database at a later date, the patient had 2 Pfizer doses, 2 primary Moderna Monovalent 0.5 ml doses that clinic administered, followed by another Pfizer. They are unable to determine dose given by the database nor location Patient had no reaction. No treatment drug details was reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: 196 patients received 0.25mL of Moderna COVID-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna COVID-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown 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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna COVID-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna COVID-19 Vaccine, Bivalent) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna COVID-19 Vaccine, Bivalent).    No concomitant medication was reported.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-689916 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up information received: Patient age group and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689916:
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: 196 patients received 0.25mL of Moderna COVID-19 Vaccine, Bivalent; No adverse event; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Dec-2022 and was forwarded to Moderna on 28-Dec-2022.    This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna COVID-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown 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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna COVID-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna COVID-19 Vaccine, Bivalent) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna COVID-19 Vaccine, Bivalent).    No concomitant medication was reported.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-689916 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up information received: Patient age group and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689916:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: 196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event) in an adult patient of an unknown 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 UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant drug information was provided. It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine. No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow-up included I-narrative updated.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: 196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown 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 UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-689916 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live significant follow up include data updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689916:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event) 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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event). At the time of the report, UNDERDOSE (patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for UNDERDOSE (patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant medication was provided by reporter. No treatment medication was provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live Significant follow up