chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Electric shock sensation, Inflammation, Injury, Mass
Clinical narrative: FELT LIKE HAD A MINI STROKE; SWELLING ON THE FEET/ FINGER PRINTS SWOLLEN; VEINS GET REALLY THICK AND FAT; HANDS, FEET AND FACE WERE ON FIRE; SWELLING ON FACE; PATIENT'S LEFT HAND GOT INFLAMED; THE INSIDE OF RIGHT ELBOW WAS HUGE LUMP; INJURY; FELT A BOLT, A SHOCK THAT WENT INTO RIGHT ELBOW AND PINKY; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient never had blood disorders and autoimmune disorders. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201AZ1A or 201A21A, expiry: unknown) dose was not reported, 1 total, administered on 16-AUG-2021 to right arm for covid-19 prophylaxis. No concomitant medications were reported.  On 16-AUG-2021, after the vaccination, patient had an injury at the moment. It was reported that, when patient got the injection, she felt a bolt, a shock that went into right elbow and pinky. On 21-AUG-2021 (5 days later), patient reported on the inside of right elbow was huge lump. Patient thought that was a swollen gland, a lymph node. It was the size of a walnut for 12 months. On 26-AUG-2021 (5 days after that), patient's left hand got inflamed and was swollen, red, shiny, glossy, puffy and weird looking. On 28-AUG-2021 (couple of days later), patient had swelling to the feet then face (swollen face) and it just kept accelerating. Patient saw a doctor (had physician office visit) and said that was from the vaccine, but did not know what to do about it (no diagnosis given by doctor). On an unspecified date, patient's hands, feet and face were on fire, it was hard to walk or touch things, veins got really thick and fat. Patient went to get fingerprints but they could not do it as they were swollen. Patients left side was worse. On an unspecified date, patient felt like she had a mini stroke from left eye to the entire side of body.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from the inside of right elbow was huge lump on AUG-2022, and the outcome of felt a bolt, a shock that went into right elbow and pinky, hands, feet and face were on fire, felt like had a mini stroke, injury, patient's left hand got inflamed, veins get really thick and fat, swelling on face and swelling on the feet/ finger prints swollen was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221252136- Felt like ministroke. The event has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Oedema peripheral, Swelling face, Transient ischaemic attack, Vein disorder
Clinical narrative: FELT LIKE HAD A MINI STROKE; SWELLING ON THE FEET/ FINGER PRINTS SWOLLEN; VEINS GET REALLY THICK AND FAT; HANDS, FEET AND FACE WERE ON FIRE; SWELLING ON FACE; PATIENT'S LEFT HAND GOT INFLAMED; THE INSIDE OF RIGHT ELBOW WAS HUGE LUMP; INJURY; FELT A BOLT, A SHOCK THAT WENT INTO RIGHT ELBOW AND PINKY; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient never had blood disorders and autoimmune disorders. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201AZ1A or 201A21A, expiry: unknown) dose was not reported, 1 total, administered on 16-AUG-2021 to right arm for covid-19 prophylaxis. No concomitant medications were reported.  On 16-AUG-2021, after the vaccination, patient had an injury at the moment. It was reported that, when patient got the injection, she felt a bolt, a shock that went into right elbow and pinky. On 21-AUG-2021 (5 days later), patient reported on the inside of right elbow was huge lump. Patient thought that was a swollen gland, a lymph node. It was the size of a walnut for 12 months. On 26-AUG-2021 (5 days after that), patient's left hand got inflamed and was swollen, red, shiny, glossy, puffy and weird looking. On 28-AUG-2021 (couple of days later), patient had swelling to the feet then face (swollen face) and it just kept accelerating. Patient saw a doctor (had physician office visit) and said that was from the vaccine, but did not know what to do about it (no diagnosis given by doctor). On an unspecified date, patient's hands, feet and face were on fire, it was hard to walk or touch things, veins got really thick and fat. Patient went to get fingerprints but they could not do it as they were swollen. Patients left side was worse. On an unspecified date, patient felt like she had a mini stroke from left eye to the entire side of body.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from the inside of right elbow was huge lump on AUG-2022, and the outcome of felt a bolt, a shock that went into right elbow and pinky, hands, feet and face were on fire, felt like had a mini stroke, injury, patient's left hand got inflamed, veins get really thick and fat, swelling on face and swelling on the feet/ finger prints swollen was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221252136- Felt like ministroke. The event has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ALMOST DIED; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced almost died. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of almost died was not reported. This report was non-serious. This case, from the same reporter is linked to 20221252705.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19 pneumonia
Clinical narrative: COVID TURNED INTO PNEUMONIA; This spontaneous report received from a patient via a company representative via social media (J and J Corporate) concerned a patient of unspecified age, sex, race and ethnicity. Initial information was processed along with additional information on 27-DEC-2022. The patient's weight was 115 (unspecified unit) and height was 170.18 centimeters. The patient's pre-existing medical conditions included: Patient ate healthy and take care of him/herself. No obesity or other risk factors. The patient was previously received with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of 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 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced covid which turned into pneumonia (Dose number in series 2). It was reported as "my friends don't have any of those factors and still have had it bad. I've had the vaccines and had a severe case of Covid and it turned into pneumonia. I'm 5'7 and weigh 115. I eat healthy and take care of myself. No obesity or other risk factorssave it!! " The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid turned into pneumonia was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20221257349. This report was associated with product quality complaint: 90000264778.; Sender's Comments: V0: 20221257371- covid turned into pneumonia. The event is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect. Therefore, this event is considered inconsistent with vaccine administration.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID; This spontaneous report received from a consumer via a company representative concerned multiple patients. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000264793. This case, from the same reporter is linked to 20221257674 and 20221258686.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEAD; This spontaneous report received from a consumer via social media via a company representative concerned multiple patients of an unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients died from unknown cause of death. It was unknown if an autopsy was performed. It was reported that, "I tried to warned as many people that would listen to me, not to take those dangerous shots very few people would listen to me, and some are dead now for not doing so. One lady (Not in my Sunday School Class, but is a church member), had two miscarriages after taking them. Everyone (53 members) in my Sunday School class took the shots, even though I warned them good not to take the shots Almost everyone in my class has had COVID since taking the shots They are now mighty quite about it all, when they announce that a member of our class now has COVID Some have had COVID the second time around, and they are filled up with those dangerous chemicals and man made viruses, that they allowed stupid doctors to give to them. When I was warning them, some of them said stupid things to me for not being protected, and risking other people's lives by catching it, and spreading it I don't hear a peep out of any of them now I did my research and I listened to "Real Doctors" Less". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20221257582.; Sender's Comments: V0: 20221257674 -dead. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: HEART PROBLEMS; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. 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, batch number and expiry were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced heart problems. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart problems. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Breast pain
Clinical narrative: SEVERE BREAST PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: autoimmune disorder. The patient experienced joint pain when treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced severe breast pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe breast pain was not reported. This report was non-serious. This case, involving the same patient is linked to 20221257637.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SAME THING HAPPENED (ADVERSE EVENT); This spontaneous report received from a patient via a company representative via social media (J and J Corporate) concerned a patient of unspecified age, sex, race and ethnicity. 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, 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 administered for covid-19 prophylaxis. It was not reported whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1, unspecified manufacturer). The patient received 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 administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced same thing happened (adverse event) (dose number in series 2). Reporter stated that, "I had the same thing happen with my booster". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of same thing happened (adverse event) was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: COUGH; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cough. This report was non-serious. This case, from the same reporter is linked to 20221258056 and 20221258060.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (pfizer) concerned a 41 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, 1 total, administered at left arm on 11-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 40 years old. No concomitant medications were reported.   The patient also received non-company suspect vaccine Spikevax (elasomeran) (Dose number in series 2) (form of admin and route of admin was not reported, batch number: 027HZ1B expiry: unknown) dose was not reported, administered at left arm on 20-NOV-2021 for covid-19 prophylaxis which was associated with revaccination with different covid-19 vaccine (Dose number in series 2). On an unspecified date in 2022, the patient had covid-19 (suspected covid-19 infection) for which she received non company suspect drug as paxlovid (form of admin and route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, administered from 07-DEC-2022 to 11-DEC-2022 for covid-19. On 15-DEC-2022, the patient experienced covid rebound (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable and with paxlovid was drug withdrawn. The patient had not recovered from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Gait inability
Clinical narrative: COULD NOT WALK 4 DAYS; This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis.  The patient could not walk for 6 days after with first dose of covid-19 vaccine ad26. cov2. s (Dose number in series 1). The patient recovered from could not walk for 6 days. The patient additionally received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient could not walk 4 days after dose 2 (Dose number in series 2) Reporter stated, "I could not walk x 6 days after 1 and then 4 days after 2 shot, scarey, very scarey" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of could not walk 4 days was not reported. This report was non-serious. This case, involving the same patient is linked to 20221257284.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Moderna Covid-19 Bivalent were administered BUD (17Dec2022) on 19Dec2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 Bivalent were administered BUD (17Dec2022) on 19Dec2022) 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)) (batch no. 019H22A, 15H22A) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Lot: 015H22A - 4 doses Administered on 19Dec2022 to 4 patients. (BUD 16Dec2022) **HCP consents to providing initials & DOB of recipients via email pending approval from superiors.     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 EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 Bivalent were administered BUD (17Dec2022) on 19Dec2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 Bivalent were administered BUD (17Dec2022) on 19Dec2022) 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 (Moderna Covid-19 Bivalent were administered BUD (17Dec2022) on 19Dec2022).    No concomitant medication information was provided.  It was reported that Moderna Covid-19 Bivalent were administered BUD (17Dec2022) on 19Dec2022 & 20Dec2022 Lot: 019H22A - Administered on 20Dec2022 to 3 patients (BUD 17Dec2022) , Lot: 015H22A - 4 doses Administered on 19Dec2022 to 4 patients. (BUD 16Dec2022)    No treatment medications were provided
Age: 1.5
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Inappropriate schedule of product administration, No adverse event
Clinical narrative: Inappropriate schedule of vaccine received a 3rd dose of the primary series instead of the bivalent vaccine; 18 month old son probably received a 3rd dose of the primary series instead of the bivalent vaccine but the vaccination provider wasn't sure of this potential administration error; No Adverse Event; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine received a 3rd dose of the primary series instead of the bivalent vaccine), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (18 month old son probably received a 3rd dose of the primary series instead of the bivalent vaccine but the vaccination provider wasn't sure of this potential administration error) and NO ADVERSE EVENT (No Adverse Event) in an 18-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     It was unknown regarding relevant medical history/conditions, allergy, concomitant diseases and risk factor.     On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine received a 3rd dose of the primary series instead of the bivalent vaccine), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (18 month old son probably received a 3rd dose of the primary series instead of the bivalent vaccine but the vaccination provider wasn't sure of this potential administration error) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine received a 3rd dose of the primary series instead of the bivalent vaccine), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (18 month old son probably received a 3rd dose of the primary series instead of the bivalent vaccine but the vaccination provider wasn't sure of this potential administration error) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.            No concomitant medications details were reported.  It was unknown if patient received vaccines in the 4 weeks prior to COVID-19 vaccine. Moderna was not authorized to communicate with the vaccine recipient's primary healthcare professional regarding this notification. Safety team did not had consent for follow-up. Caregiver stated her 18 month old son probably received a third dose of the primary series instead of the bivalent vaccine but the vaccination provider wasn't sure of this potential administration error. There are no additional details available. It was unknown if the patient experienced any AEs.  No treatment medications details were reported.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Overdose
Clinical narrative: Moderna COVID-19 vaccine at 0.5 ml instead of 0.25ml dose; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of OVERDOSE (Moderna COVID-19 vaccine at 0.5 ml instead of 0.25ml dose) and NO ADVERSE EVENT (No Adverse Event) in a 6-year-old female patient 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.     The patient's past medical history included FLU.    On 22-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) .5 milliliter. On an unknown date, the patient experienced OVERDOSE (Moderna COVID-19 vaccine at 0.5 ml instead of 0.25ml dose) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, OVERDOSE (Moderna COVID-19 vaccine at 0.5 ml instead of 0.25ml dose) 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 OVERDOSE (Moderna COVID-19 vaccine at 0.5 ml instead of 0.25ml dose).    No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Placed in fridge Nov. 15Administered today; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Placed in fridge Nov. 15Administered today) 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. AS7167B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-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 23-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Placed in fridge Nov. 15Administered today) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Placed in fridge Nov. 15Administered today) 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 (Placed in fridge Nov. 15Administered today).    No concomitant medication information was reported. No treatment medication information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Antibodies got lower after receiving the bivalent vaccine; This spontaneous case was reported by a non-health professional and describes the occurrence of IMMUNISATION REACTION (Antibodies got lower after receiving the bivalent vaccine) 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 IMMUNISATION REACTION (Antibodies got lower after receiving the bivalent vaccine). At the time of the report, IMMUNISATION REACTION (Antibodies got lower after receiving the bivalent vaccine) outcome was unknown.        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 unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; an expired Moderna COVID-19 bivalent vaccine was administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (an expired Moderna COVID-19 bivalent vaccine was administered) 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. AS7162B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-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 16-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 (an expired Moderna COVID-19 bivalent vaccine was administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (an expired Moderna COVID-19 bivalent vaccine was administered) 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 (an expired Moderna COVID-19 bivalent vaccine was administered).    No concomitant medications were reported.  It was reported  that an expired Moderna COVID-19 bivalent vaccine was administered to 1 or 2 patients on 16-Dec-2022.which was placed in the refrigerator on 2-NOV-2022 and best use date was 2-Dec-2022.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; Patient administered pediatric monovalent vaccine instead of bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient administered pediatric monovalent vaccine instead of bivalent booster) 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. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient administered pediatric monovalent vaccine instead of bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient administered pediatric monovalent vaccine instead of bivalent booster) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient administered pediatric monovalent vaccine instead of bivalent booster).    This case contains information for the 11th of 16 adult patients described by the reporter. No concomitant product reported by reporter. No treatment medication reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-692175 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-692175 case
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, Inappropriate schedule of product administration, No adverse event
Clinical narrative: due to interval between 1st and 2nd primary doses, they administered 0.25 Moderna monovalent booster on 20May2022; patient received 0.25 dose and not a full second dose; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (due to interval between 1st and 2nd primary doses, they administered 0.25 Moderna monovalent booster on 20May2022), ACCIDENTAL UNDERDOSE (patient received 0.25 dose and not a full second dose) and NO ADVERSE EVENT (No adverse event) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 20-May-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (due to interval between 1st and 2nd primary doses, they administered 0.25 Moderna monovalent booster on 20May2022), ACCIDENTAL UNDERDOSE (patient received 0.25 dose and not a full second dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (due to interval between 1st and 2nd primary doses, they administered 0.25 Moderna monovalent booster on 20May2022), ACCIDENTAL UNDERDOSE (patient received 0.25 dose and not a full second dose) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (due to interval between 1st and 2nd primary doses, they administered 0.25 Moderna monovalent booster on 20May2022) and ACCIDENTAL UNDERDOSE (patient received 0.25 dose and not a full second dose).    No concomitant medication information was reported. No treatment medication information was reported.  The first primary dose was given on 28Oc2021, upon reviewing the states data base, the patient received 0.25 dose and not a full second dose. HCP contacted the administering pharmacy and was told that due to interval between 1st and 2nd primary doses, they administered 0.25 Moderna monovalent booster on 20May2022 instead of 2nd primary dose. HCP was seeking guidance as what she was told did not seem correct.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: they got the main vaccine over a year ago and then In the hospital got a lot of transfusion; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (they got the main vaccine over a year ago and then In the hospital got a lot of transfusion) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) 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) Unknown. On an unknown date, the patient experienced IMMUNISATION REACTION (they got the main vaccine over a year ago and then In the hospital got a lot of transfusion). At the time of the report, IMMUNISATION REACTION (they got the main vaccine over a year ago and then In the hospital got a lot of transfusion) 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.   No concomitant and treatment medications were reported. Patient was having concern about blood transfusion and Moderna vaccine.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: patient with 26years old has tested positive for COVID19 on 22Dec2022; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Dec-2022 and was forwarded to Moderna on 27-Dec-2022.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (patient with 26years old has tested positive for COVID19 on 22Dec2022) in a 25-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.    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 22-Dec-2022, the patient experienced COVID-19 (patient with 26years old has tested positive for COVID19 on 22Dec2022). At the time of the report, COVID-19 (patient with 26years old has tested positive for COVID19 on 22Dec2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Dec-2022, SARS-CoV-2 test: Positive.     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 did not provide any causality assessments.   No concomitant medications were reported.  It was stated that a patient has tested positive for COVID19 on 22-Dec-2022 who previously received 3 doses of the Moderna COVID19 vaccine.  No treatment medications were reported.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No Adverse Event; They gave the patient a bivalent booster today 23Dec2022, but he already received it a month ago on unknown date/getting two doses of the bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (They gave the patient a bivalent booster today 23Dec2022, but he already received it a month ago on unknown date/getting two doses of the bivalent booster) and NO ADVERSE EVENT (No Adverse Event) in a 62-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-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) .5 milliliter. On 23-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (They gave the patient a bivalent booster today 23Dec2022, but he already received it a month ago on unknown date/getting two doses of the bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXTRA DOSE ADMINISTERED (They gave the patient a bivalent booster today 23Dec2022, but he already received it a month ago on unknown date/getting two doses of the bivalent booster) 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 (They gave the patient a bivalent booster today 23Dec2022, but he already received it a month ago on unknown date/getting two doses of the bivalent booster).    No concomitant medications were reported. The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Information about previous COVID-19 vaccination was unknown. They were wondering if there were any concerns that the patient should be expecting from getting two doses of the bivalent booster. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: We had some doses of Moderna bivalent that had a fridge expiration date of 12/14/22 (we don't have ultra-cold storage) and one was mistakenly given to a patient this morning; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We had some doses of Moderna bivalent that had a fridge expiration date of 12/14/22 (we don't have ultra-cold storage) and one was mistakenly given to a patient this morning) 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. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (We had some doses of Moderna bivalent that had a fridge expiration date of 12/14/22 (we don't have ultra-cold storage) and one was mistakenly given to a patient this morning) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We had some doses of Moderna bivalent that had a fridge expiration date of 12/14/22 (we don't have ultra-cold storage) and one was mistakenly given to a patient this morning) 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 (We had some doses of Moderna bivalent that had a fridge expiration date of 12/14/22 (we don't have ultra-cold storage) and one was mistakenly given to a patient this morning).    No concomitant medications were reported.  It was reported you receive any other vaccines in the 4 weeks prior to COVID-19 vaccine as unknown.  No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; My husband had a Moderna Booster last week Friday (16Dec2022). Then Pharmacy called him yesterday (22Dec2022) & said that he got the wrong dose, that he got the pediatric dose for 6yr to 11yrs.; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (My husband had a Moderna Booster last week Friday (16Dec2022). Then Pharmacy called him yesterday (22Dec2022) & said that he got the wrong dose, that he got the pediatric dose for 6yr to 11yrs.) and NO ADVERSE EVENT (No adverse event) in a 0-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-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 16-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (My husband had a Moderna Booster last week Friday (16Dec2022). Then Pharmacy called him yesterday (22Dec2022) & said that he got the wrong dose, that he got the pediatric dose for 6yr to 11yrs.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (My husband had a Moderna Booster last week Friday (16Dec2022). Then Pharmacy called him yesterday (22Dec2022) & said that he got the wrong dose, that he got the pediatric dose for 6yr to 11yrs.) had resolved 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 (My husband had a Moderna Booster last week Friday (16Dec2022). Then Pharmacy called him yesterday (22Dec2022) &amp; said that he got the wrong dose, that he got the pediatric dose for 6yr to 11yrs).    No concomitant medications were reported.  No treatment medications were reported.