chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; 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. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805020, expiry: unknown) dose was not reported, 1 total administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The patient also received non-company suspect vaccine included: BNT 162 (Dose number in series 2) (form of admin, route of admin were not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on 29-DEC-2021 for prophylactic vaccination. On 17-JAN-2022, the patient started experiencing sniffly nose. Followed by on 18-JAN-2022, experienced sore throat, sinus congestion, headache, and body aches coded as suspected covid-19 infection and suspected clinical vaccination failure (Dose number in series 1). Laboratory data included: COVID-19 rapid POC (Point-of-care) (Binaxnow) test (NR: not provided) Positive. It was reported that symptoms were not resolved yet (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint number: 90000212818.; Sender's Comments: V0: 20220133895-covid-19 vaccine ad26.cov2.s- suspected clinical vaccination failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Off label use, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; ADMINISTRATION OF EXPIRED VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned an 80 year old female of unspecified race and ethnicity. Initial information was processed with the additional information received on 20-JAN-2022. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, 1 total, administered on 07-OCT-2021 for prophylactic vaccination (administration of expired vaccine and off label use). No concomitant medications were reported.  On an unspecified date, the patient passed away due to positive COVID-19 (coronavirus disease of 2019) (suspected covid-19 infection). The reporter did not know the date of death or when the patient was confirmed to have a positive case of COVID-19. The reporter also did not know if the patient was confirmed to be positive for COVID-19 by PCR (polymerase chain reaction) or by another type of test. It was unspecified if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died from suspected covid-19 infection and outcome of the administration of expired vaccine and off label use was not reported. This report was serious (Death). This report was associated with product quality complaint: 90000212906. The suspected product quality complaint has been confirmed to be voided (did not meet criteria as vaccine was already expired when the consumer received the vaccine) based on the valuation/investigation performed. This case, from the same reporter is linked to 20220136322.; Sender's Comments: V0 20220136393-COVID-19 VACCINE AD26.COV2.S-suspected covid-19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: SUSPECTED COVID-19 INFECTION
Sex: M
Vaccine: COVID19
Symptoms: Nephrolithiasis, Ocular icterus
Clinical narrative: KIDNEY STONES; EYES WERE TURNING YELLOW; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date the patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced kidney stones, and eyes were turning yellow (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the eyes were turning yellow and kidney stones was not reported. On an unspecified date, the patient received mrna 1273 (Dose number in series 2) (form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for prophylactic vaccination. No adverse events were reported following administration of  mrna 1273 (dose number in series 2). This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220114730 and 20220136407.; Sender's Comments: V0: 20220137233- Covid-19 vaccine ad26.cov2.s- Kidney stones. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest
Clinical narrative: HEART STOPPED; This spontaneous report received from a consumer concerned a 33 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient had history of obesity, enlarged heart, and heart issue. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered 1 in total on 23-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 05-APR-2021 (13 days after vaccination), the patient's heart stopped. Patient's mother also received the shot on same day. She was told that his son's heart stopped. She wanted to know if vaccine was not safe for obese persons or people with heart issues. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died as his heart stopped on 05-Apr-2021. This report was serious (Death).; Sender's Comments: V0:20220139574-COVID-19 VACCINE AD26.COV2.S- Heart stopped This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned 11 patients of unknown race and ethnic origin. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry date: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced suspected clinical vaccination failure, and suspected covid-19 infection. On 12-JAN-2022 reporter stated that, that is how I got it. There were 25 people both vaccinated and not vaccinated and 3 people not feeling well that did not say anything and came to the christmas gathering and 13 of the 25 we ended up getting tested and positive for covid and maybe even more than 13 because a lot of them thought it was just a cold and I told them no it is covid. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000213503. This case, from the same reporter is linked to 20220108630 and 20220108126.; Sender's Comments: V0:20220140548 -COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Product complaint, Vaccination site haemorrhage
Clinical narrative: INSTANTLY STARTED TO BLEED ENOUGH THAT IT WAS RUNNING DOWN ARM; THE VIAL WAS GELATINOUS WITH LOTS OF BUBBLES; BECAME VERY ILL; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 185519, expiry: UNKNOWN) dose was not reported, administered on 18-JAN-2022 for prophylactic vaccination. No concomitant medications were reported.  On JAN-2022, the patient experienced became very ill. On 18-JAN-2022, the patient experienced instantly started to bleed enough that it was running down arm, and the vial was gelatinous with lots of bubbles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the instantly started to bleed enough that it was running down arm, became very ill and the vial was gelatinous with lots of bubbles was not reported. This report was non-serious. This case is associated with product quality complain number: 90000213424.
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Poor quality product administered
Clinical narrative: This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 12-JAN-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced vial was used beyond the 8 hours travel time (out of specification product use), and off label use. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vial was used beyond the 8 hours travel time (out of specification product use) and off label use was not reported. This report was non-serious.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Laboratory test, Palpitations
Clinical narrative: This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient never had problems with her heart. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: 23-AUG-2021) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced heart palpitations that come and go. Laboratory data (dates unspecified) included: EKG (NR: not provided) Not reported, and Lab test (NR: not provided) not reported. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart palpitations that come and go on NOV-2021. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: ELEVATED HEART RATE; MUSCLES FELT LIKE ATROPHIED; SWEATS; DRY HEAVING; CHILLS; WEAKNESS IN LEG; DIARRHEA; SEVERE HEADACHE THAT WAS FROM SHOULDERS TO BACK OF HEAD LIKE HIT WITH A 2 BY 4 (LINGERING PERMEANT HEADACHE IN THE BACK OF HEAD); FEVER (102); NAUSEA; FATIGUE; SEVERE ARM PAIN AND COULD NOT LIFT ARM; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's past medical history included: migraines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, expiry: UNKNOWN) dose was not reported, administered on 25-SEP-2021 10:30 for prophylactic vaccination. No concomitant medications were reported.  On 25-SEP-2021, the patient experienced severe arm pain and could not lift arm. On 26-SEP-2021, the patient experienced elevated heart rate, muscles felt like atrophied, sweats, dry heaving, chills, weakness in leg, diarrhea, severe headache that was from shoulders to back of head like hit with a 2 by 4 (lingering permeant headache in the back of head), fever (102), nausea, and fatigue. Laboratory data included: Body temperature (NR: not provided) 102. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) 71, 80's/88, 90's. Treatment medications (dates unspecified) included: acetylsalicylic acid/caffeine/paracetamol/salicylamide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscles felt like atrophied, sweats, dry heaving, chills, diarrhea, fever (102), nausea, and fatigue, and severe arm pain and could not lift arm, and weakness in leg on 27-SEP-2021, and had not recovered from severe headache that was from shoulders to back of head like hit with a 2 by 4 (lingering permeant headache in the back of head), and elevated heart rate. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Hyperhidrosis, Muscle atrophy, Muscular weakness
Clinical narrative: ELEVATED HEART RATE; MUSCLES FELT LIKE ATROPHIED; SWEATS; DRY HEAVING; CHILLS; WEAKNESS IN LEG; DIARRHEA; SEVERE HEADACHE THAT WAS FROM SHOULDERS TO BACK OF HEAD LIKE HIT WITH A 2 BY 4 (LINGERING PERMEANT HEADACHE IN THE BACK OF HEAD); FEVER (102); NAUSEA; FATIGUE; SEVERE ARM PAIN AND COULD NOT LIFT ARM; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's past medical history included: migraines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, expiry: UNKNOWN) dose was not reported, administered on 25-SEP-2021 10:30 for prophylactic vaccination. No concomitant medications were reported.  On 25-SEP-2021, the patient experienced severe arm pain and could not lift arm. On 26-SEP-2021, the patient experienced elevated heart rate, muscles felt like atrophied, sweats, dry heaving, chills, weakness in leg, diarrhea, severe headache that was from shoulders to back of head like hit with a 2 by 4 (lingering permeant headache in the back of head), fever (102), nausea, and fatigue. Laboratory data included: Body temperature (NR: not provided) 102. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) 71, 80's/88, 90's. Treatment medications (dates unspecified) included: acetylsalicylic acid/caffeine/paracetamol/salicylamide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscles felt like atrophied, sweats, dry heaving, chills, diarrhea, fever (102), nausea, and fatigue, and severe arm pain and could not lift arm, and weakness in leg on 27-SEP-2021, and had not recovered from severe headache that was from shoulders to back of head like hit with a 2 by 4 (lingering permeant headache in the back of head), and elevated heart rate. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia, Retching
Clinical narrative: ELEVATED HEART RATE; MUSCLES FELT LIKE ATROPHIED; SWEATS; DRY HEAVING; CHILLS; WEAKNESS IN LEG; DIARRHEA; SEVERE HEADACHE THAT WAS FROM SHOULDERS TO BACK OF HEAD LIKE HIT WITH A 2 BY 4 (LINGERING PERMEANT HEADACHE IN THE BACK OF HEAD); FEVER (102); NAUSEA; FATIGUE; SEVERE ARM PAIN AND COULD NOT LIFT ARM; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's past medical history included: migraines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, expiry: UNKNOWN) dose was not reported, administered on 25-SEP-2021 10:30 for prophylactic vaccination. No concomitant medications were reported.  On 25-SEP-2021, the patient experienced severe arm pain and could not lift arm. On 26-SEP-2021, the patient experienced elevated heart rate, muscles felt like atrophied, sweats, dry heaving, chills, weakness in leg, diarrhea, severe headache that was from shoulders to back of head like hit with a 2 by 4 (lingering permeant headache in the back of head), fever (102), nausea, and fatigue. Laboratory data included: Body temperature (NR: not provided) 102. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) 71, 80's/88, 90's. Treatment medications (dates unspecified) included: acetylsalicylic acid/caffeine/paracetamol/salicylamide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscles felt like atrophied, sweats, dry heaving, chills, diarrhea, fever (102), nausea, and fatigue, and severe arm pain and could not lift arm, and weakness in leg on 27-SEP-2021, and had not recovered from severe headache that was from shoulders to back of head like hit with a 2 by 4 (lingering permeant headache in the back of head), and elevated heart rate. This report was non-serious.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea exertional, Gait disturbance, Headache
Clinical narrative: SHORTNESS OF BREATH WHEN WALKING FROM ONE ROOM TO ANOTHER; CHEST PAIN; DIFFICULTY WALKING/WANTING TO JUST LAY DOWN; HEADACHE; This spontaneous report received from a consumer concerned a 19 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: 11-APR-2022) dose was not reported, administered on 21-JAN-2022 for prophylactic vaccination. No concomitant medications were reported. On JAN-2022, treatment medications included: paracetamol. On 21-JAN-2022, the patient experienced shortness of breath when walking from one room to another, chest pain, difficulty walking/wanting to just lay down, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath when walking from one room to another, headache, chest pain, and difficulty walking/wanting to just lay down. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Skin wrinkling
Clinical narrative: This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced more wrinkles on hands and forearms. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from more wrinkles on hands and forearms. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Gait disturbance
Clinical narrative: TROUBLE WALKING; 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. No past medical history or concurrent conditions were 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 prophylactic vaccination. 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 trouble walking. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of trouble walking was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Gait disturbance, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Could hardly walk), CHILLS (Chilling and shivering/She used 7 blankets and was still freezing) and MYALGIA (Body aches) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination. No Medical History information was reported. On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (Could hardly walk), CHILLS (Chilling and shivering/She used 7 blankets and was still freezing) and MYALGIA (Body aches). At the time of the report, GAIT DISTURBANCE (Could hardly walk), CHILLS (Chilling and shivering/She used 7 blankets and was still freezing) and MYALGIA (Body aches) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant product use was provided. It was reported that about 12 hours later, the patient experienced chilling and shivering. No treatment medication was provided. This case was linked to MOD-2022-456356, MOD-2022-456359 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Gait disturbance, Myalgia, Peripheral swelling, Pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Could hardly walk), CHILLS (Chilling and shivering/She used 7 blankets and was still freezing) and MYALGIA (Body aches) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination. No Medical History information was reported. On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (Could hardly walk), CHILLS (Chilling and shivering/She used 7 blankets and was still freezing) and MYALGIA (Body aches). At the time of the report, GAIT DISTURBANCE (Could hardly walk), CHILLS (Chilling and shivering/She used 7 blankets and was still freezing) and MYALGIA (Body aches) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant product use was provided. It was reported that about 12 hours later, the patient experienced chilling and shivering. No treatment medication was provided. This case was linked to MOD-2022-456356, MOD-2022-456359 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Gait disturbance, Myalgia
Clinical narrative: Veins on top part of her feet bulged really big; Severe itching on bottom of her feet and palms of her hands; Body aches; After after Booster again she experienced chilling and shivering/She used 7 blankets and was still freezing.; could hardly walk.; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (could hardly walk.), PERIPHERAL SWELLING (Veins on top part of her feet bulged really big), PRURITUS (Severe itching on bottom of her feet and palms of her hands), MYALGIA (Body aches) and CHILLS (After after Booster again she experienced chilling and shivering/She used 7 blankets and was still freezing.) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 010M20A and 025J202A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced GAIT DISTURBANCE (could hardly walk.), MYALGIA (Body aches) and CHILLS (After after Booster again she experienced chilling and shivering/She used 7 blankets and was still freezing.). On 14-Nov-2021, the patient experienced PERIPHERAL SWELLING (Veins on top part of her feet bulged really big) and PRURITUS (Severe itching on bottom of her feet and palms of her hands). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE (BENADRYL ITCH RELIEF) for Itching, at an unspecified dose and frequency. In October 2021, GAIT DISTURBANCE (could hardly walk.), MYALGIA (Body aches) and CHILLS (After after Booster again she experienced chilling and shivering/She used 7 blankets and was still freezing.) had resolved. At the time of the report, PERIPHERAL SWELLING (Veins on top part of her feet bulged really big) outcome was unknown and PRURITUS (Severe itching on bottom of her feet and palms of her hands) was resolving.            No concomitant medications were reported  Other treatment medication includes steroid pack  Patient stated that It only happened at night and now it was periodically   This case was linked to MOD-2022-456330, MOD-2022-456356 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Gait disturbance, Myalgia, Peripheral swelling, Pruritus
Clinical narrative: Veins on top part of her feet bulged really big; Severe itching on bottom of her feet and palms of her hands; Body aches; After after Booster again she experienced chilling and shivering/She used 7 blankets and was still freezing.; could hardly walk.; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (could hardly walk.), PERIPHERAL SWELLING (Veins on top part of her feet bulged really big), PRURITUS (Severe itching on bottom of her feet and palms of her hands), MYALGIA (Body aches) and CHILLS (After after Booster again she experienced chilling and shivering/She used 7 blankets and was still freezing.) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 010M20A and 025J202A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced GAIT DISTURBANCE (could hardly walk.), MYALGIA (Body aches) and CHILLS (After after Booster again she experienced chilling and shivering/She used 7 blankets and was still freezing.). On 14-Nov-2021, the patient experienced PERIPHERAL SWELLING (Veins on top part of her feet bulged really big) and PRURITUS (Severe itching on bottom of her feet and palms of her hands). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE (BENADRYL ITCH RELIEF) for Itching, at an unspecified dose and frequency. In October 2021, GAIT DISTURBANCE (could hardly walk.), MYALGIA (Body aches) and CHILLS (After after Booster again she experienced chilling and shivering/She used 7 blankets and was still freezing.) had resolved. At the time of the report, PERIPHERAL SWELLING (Veins on top part of her feet bulged really big) outcome was unknown and PRURITUS (Severe itching on bottom of her feet and palms of her hands) was resolving.            No concomitant medications were reported  Other treatment medication includes steroid pack  Patient stated that It only happened at night and now it was periodically   This case was linked to MOD-2022-456330, MOD-2022-456356 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Nausea, Seizure
Clinical narrative: Atrial Fibrillation; Seizure; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Atrial Fibrillation) and SEIZURE (Seizure) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A,NDC80777-273-10) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Atrial fibrillation (Patient gets Atrial fibrillation periodically.).    On 21-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced ATRIAL FIBRILLATION (Atrial Fibrillation) (seriousness criterion medically significant), SEIZURE (Seizure) (seriousness criterion medically significant) and NAUSEA (Nauseous). In February 2021, SEIZURE (Seizure) had resolved. At the time of the report, ATRIAL FIBRILLATION (Atrial Fibrillation) and NAUSEA (Nauseous) outcome was unknown.            No concomitant product was provided. No treatment information was provided.  Patient does not have a seizure before. They called 911 but seizure was over-with shortly before they arrived. Company comment: This Spontaneous case concerns a 78-year-old, male patient, with medical history of atrial fibrillation, who experienced the unexpected, serious (Medically significant) and AESI of atrial fibrillation and seizure, among others. The patient developed atrial fibrillation and seizure after 1 day of receiving the second dose of mRNA-1273 vaccine. It was reported that the patient had episodes of atrial fibrillation before, however, it was the first time he experienced a seizure. Patient's age and the with medical history of atrial fibrillation remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events atrial fibrillation and seizure were automatically upgraded as a Serious event as per IME list and kept as serious as per medical judgement, despite they were reported as non-serious.; Sender's Comments: This Spontaneous case concerns a 78-year-old, male patient, with medical history of atrial fibrillation, who experienced the unexpected, serious (Medically significant) and AESI of atrial fibrillation and seizure, among others. The patient developed atrial fibrillation and seizure after 1 day of receiving the second dose of mRNA-1273 vaccine. It was reported that the patient had episodes of atrial fibrillation before, however, it was the first time he experienced a seizure. Patient's age and the with medical history of atrial fibrillation remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events atrial fibrillation and seizure were automatically upgraded as a Serious event as per IME list and kept as serious as per medical judgement, despite they were reported as non-serious.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: started having dizzies spells when they move their head, like if they are reading and move head around, or when they laid down at night and head hit the pillow at night, their health otherwise is fine; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (started having dizzies spells when they move their head, like if they are reading and move head around, or when they laid down at night and head hit the pillow at night, their health otherwise is fine) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 001B21A and 008B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (started having dizzies spells when they move their head, like if they are reading and move head around, or when they laid down at night and head hit the pillow at night, their health otherwise is fine). At the time of the report, DIZZINESS (started having dizzies spells when they move their head, like if they are reading and move head around, or when they laid down at night and head hit the pillow at night, their health otherwise is fine) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported.  No treatment medication details was reported.  It was reported that when they move their head, like if they are reading and move head around, or when they laid down at night and head hit the pillow at night, their health otherwise was fine   This case was linked to MOD-2021-400114 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2022: Follow-up received on 24-Jan-2022 contains significant information: Causality updated from related to not related for all event.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 20-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced COVID-19 (tested positive). On 14-Jan-2022, COVID-19 (tested positive) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. Treatment medications were not reported. Sender's Comments: This is a spontaneous case concerning a 52-year-old male patient with no reported medical history, who experienced the non-serious unexpected AESI event of COVID-19. The event occurred approximately 15 days after the first dose of mRNA-1273 vaccine administration and recovered in 12 days. Causality for the event of COVID-19 was not applicable. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Chills, Headache, Myalgia, Pain in extremity
Clinical narrative: Mild sore arm; Arthritis gets to acting up as I get going; Mild chills; Mild body ache; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Mild sore arm), ARTHRITIS (Arthritis gets to acting up as I get going), CHILLS (Mild chills), MYALGIA (Mild body ache) and HEADACHE (Headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 027CZ0A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis (Arthritis in knees).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jan-2022 at 9:30 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced PAIN IN EXTREMITY (Mild sore arm), ARTHRITIS (Arthritis gets to acting up as I get going), CHILLS (Mild chills), MYALGIA (Mild body ache) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Mild sore arm), CHILLS (Mild chills), MYALGIA (Mild body ache) and HEADACHE (Headache) had not resolved and ARTHRITIS (Arthritis gets to acting up as I get going) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Fibromyalgia, Poor quality sleep
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FIBROMYALGIA (Felt her fibromyalgia (musculoskeletal pain) more amplified than before taking vaccine) and POOR QUALITY SLEEP (She is also experiencing poorer sleep quality) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 vaccination. Concurrent medical conditions included Fibromyalgia. In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FIBROMYALGIA (Felt her fibromyalgia (musculoskeletal pain) more amplified than before taking vaccine) and POOR QUALITY SLEEP (She is also experiencing poorer sleep quality). At the time of the report, FIBROMYALGIA (Felt her fibromyalgia (musculoskeletal pain) more amplified than before taking vaccine) and POOR QUALITY SLEEP (She is also experiencing poorer sleep quality) outcome was unknown. No concomitant medication were provided. No treatment details were provided. It was reported that the patient felt her fibromyalgia more amplified than before taking vaccine and it happened more frequently when the weather changes. Company comment: This case concerns a female patient of an unknown age with relevant medical history of Fibromyalgia, who experienced non-serious unexpected worsening of Fibromyalgia and poorer sleep quality after the second dose of mRNA-1273. The events occurred in an unknown temporal relationship to vaccine administration. Treatment information was not disclosed and outcome is unknown. The nature of underlying Fibromyalgia remains a major confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Sender's Comments: This case concerns a female patient of an unknown age with relevant medical history of Fibromyalgia, who experienced non-serious unexpected worsening of Fibromyalgia and poorer sleep quality after the second dose of mRNA-1273. The events occurred in an unknown temporal relationship to vaccine administration. Treatment information was not disclosed and outcome is unknown. The nature of underlying Fibromyalgia remains a major confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 96.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: He stated the man contracted COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (He stated the man contracted COVID-19) in a 96-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced COVID-19 (He stated the man contracted COVID-19) (seriousness criterion hospitalization). The patient was hospitalized from sometime in December 2021 to 10-Jan-2022 due to COVID-19. At the time of the report, COVID-19 (He stated the man contracted COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.         No Concomitant medications were provided.  The caller stated the patient still testing positive on PCR tests and active for COVID-19 per PCR tests and patient has not yet received the Moderna booster dose.  Treatment Information was not provided.  Company comment: This case concerns a 96-year-old, male patient with no medical history reported, who experienced the unexpected event of COVID 19, which required hospitalization. The events occurred after two doses of mRNA-1273. As reported, the patient was hospitalized from sometime in December 2021 to 10-Jan-2022 due to COVID-19. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.    Most recent FOLLOW-UP information incorporated above includes: On 18-Jan-2022: Case upgraded to serious, Event seriousness criteria hospitalization added, lab test, Reporter information and dosage details updated.; Sender's Comments: This case concerns a 96-year-old, male patient with no medical history reported, who experienced the unexpected event of COVID 19, which required hospitalization. The events occurred after two doses of mRNA-1273. As reported, the patient was hospitalized from sometime in December 2021 to 10-Jan-2022 due to COVID-19. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Tested positive for Covid) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for Covid). At the time of the report, COVID-19 (Tested positive for Covid) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Tested positive for COVID. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient received monoclonal infusion treatment for COVID-19. Concomitant products were not provided. Company comment: This case concerns a patient with no medical history reported, who experienced the unexpected n0n serious event of COVID 19. The event occurred after second dose of mRNA-1273. As reported the patient tested positive for COVID 19 and vas treated with monoclonal antibodies. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This case concerns a patient with no medical history reported, who experienced the unexpected n0n serious event of COVID 19. The event occurred after second dose of mRNA-1273. As reported the patient tested positive for COVID 19 and vas treated with monoclonal antibodies. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got COVID-19 in the beginning of January and still has symptoms) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Atrial fibrillation (significant health issues). In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced COVID-19 (got COVID-19 in the beginning of January and still has symptoms). At the time of the report, COVID-19 (got COVID-19 in the beginning of January and still has symptoms) had not resolved. Concomitant and Treatment information were not provided. Reporter did not allow further contact. Company comment: This case concerns a 70-year-old, female patient with no relevant medical history, who experienced the unexpected non serious event of COVID-19. The events occurred approximately 7 months after the second dose of mRNA-1273. The patient was vaccinated with two doses of mRNA-1273 however, no exact administration dates were provided. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This case concerns a 70-year-old, female patient with no relevant medical history, who experienced the unexpected non serious event of COVID-19. The events occurred approximately 7 months after the second dose of mRNA-1273. The patient was vaccinated with two doses of mRNA-1273 however, no exact administration dates were provided. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.