chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: HEARING LOSS; This spontaneous report received from a patient via social media 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Patient was on a diuretic and an antihistamine for about a month with no change. Previously had a course of steroid tablets (no effect) and three steroid shots in the eardrum. On an unspecified date, the patient experienced hearing loss. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hearing loss was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210905661 -covid-19 vaccine ad26.cov2.s- hearing loss. 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).
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Illness, Paraesthesia
Clinical narrative: VERY MILD TINGLING FEELING THROUGHOUT THE BODY; VERY MILD NUMBNESS FEELING THROUGHOUT THE BODY; HEADACHE; SICK; This spontaneous report received from a patient concerned a 40 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: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 31-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-AUG-2021, the patient experienced sick. On 31-AUG-2021, the patient experienced headache. On 01-SEP-2021, the patient experienced very mild tingling feeling throughout the body. On 01-SEP-2021, the patient experienced very mild numbness feeling throughout the body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, sick, very mild tingling feeling throughout the body and very mild numbness feeling throughout the body was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: AFTER VACCINATION PSORIASIS BREAKOUT WORSE AND SPREADING; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriasis, and other pre-existing medical conditions included: Patient had history of psoriasis in his late 20's. The patient stated It would flare up and stayed in the same areas. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 21-SEP-2021) dose was not reported, administered on 26-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced after vaccination psoriasis breakout worse and spreading. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of after vaccination psoriasis breakout worse and spreading was not reported. This report was non-serious.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 17 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, and expiry: 11-DEC-2021) dose was not reported, administered on 02-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-SEP-2021, the patient experienced off label use. On 02-SEP-2021, the patient experienced inappropriate age at vaccine administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and inappropriate age at vaccine administration was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: LOWER LEG PAIN; 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. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-APR-2021, the patient experienced lower leg pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lower leg pain on 16-APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210525539.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: SWEATING PROFUSELY; This spontaneous report received from a patient concerned a 71 year old male. The patient's height, and weight were not reported. The patient's past medical history included: car accident, and coma, and concurrent conditions included: no alcohol use, and smoker, and other pre-existing medical conditions included: The Patient have No known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 23-JUN-2021) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the patient experienced profusely sweating. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from profusely sweating. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: SORE ARM; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol use, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies and no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 02-SEP-2021, the patient experienced sore arm. On 02-SEP-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and sore arm. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea exertional, Respiration abnormal
Clinical narrative: DEVELOPED BREATHING ISSUES; SHORTNESS OF BREATH AND LABORED BREATHING ON EXERTION, PATIENT LET IT GO UNTIL IT BECAME EXTREMELY PROBLEMATIC; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: mild hypertension, and cholesterol, and other pre-existing medical conditions included: Patient was in reasonably good health. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported 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 developed breathing issues, and shortness of breath and labored breathing on exertion, patient let it go until it became extremely problematic. Treatment medications (dates unspecified) included: salbutamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath and labored breathing on exertion, patient let it go until it became extremely problematic, and the outcome of developed breathing issues was not reported. This report was non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Head discomfort, Pain
Clinical narrative: HEAVINESS OF HEAD; BODY ACHE; CHILLS; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was not pregnant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. Concomitant medications included metformin.  On 01-SEP-2021, the patient experienced heaviness of head. On 01-SEP-2021, the patient experienced body ache. On 01-SEP-2021, the patient experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heaviness of head, chills, and body ache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER OF 101.8F FOR TWO DAYS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported 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 fever of 101.8f for two days. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever of 101.8f for two days. This report was non-serious. This case, from the same reporter is linked to 20210905680.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered
Clinical narrative: ADMINISTRATION OF VACCINE 1 HOUR PAST RECOMMENDED STORAGE TIME; This spontaneous report received from a health care professional concerned a 34 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027, expiry: 29-SEP-2021) dose was not reported, administered on 02-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-SEP-2021, the patient experienced administration of vaccine 1 hour past recommended storage time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of vaccine 1 hour past recommended storage time was not reported. This report was non-serious. This case, from the same reporter is linked to 20210905756 and 20210905816.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: ADMINISTRATION OF VACCINE 1 HOUR PAST RECOMMENDED STORAGE TIME; This spontaneous report received from a health care professional concerned a 34 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027, expiry: 29-SEP-2021) dose was not reported, administered on 02-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-SEP-2021, the patient experienced administration of vaccine 1 hour past recommended storage time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of vaccine 1 hour past recommended storage time was not reported. This report was non-serious. This case, from the same reporter is linked to 20210905756 and 20210905816.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Skin disorder
Clinical narrative: WEIRD DARK AND LIGHT SPOTS ON SKIN LIKE BRUISES, VARYING SIZES, DARKEST BETWEEN BONES IN HAND AND TOES ESPECIALLY, LARGEST ON THUMB, BOTH ARMS AND FEET AND TURNS INTO FUNNY BROWNISH/ PURPLE COLOR; ON AND OFF DIZZINESS; This spontaneous report received from a patient concerned an 89 year old female. The patient's weight was 160 pounds, and height was 64 inches. The patient's past medical history included: swollen throat, and skin reaction, and concurrent conditions included: scarring on the lungs, allergic to sulfa drugs, allergic to most antibiotics, penicillin allergy, non alcohol user, non smoker, skin tan, and small vein in legs, and other pre-existing medical conditions included: Patient always had a lot of trouble with shots. Patient tan easily. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 22-JUL-2021 for prophylactic vaccination. Concomitant medications included diphenhydramine hydrochloride for allergic reaction. On 23-JUL-2021, the patient experienced on and off dizziness. On 30-AUG-2021, the patient experienced weird dark and light spots on skin like bruises, varying sizes, darkest between bones in hand and toes especially, largest on thumb, both arms and feet and turns into funny brownish/ purple color. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from on and off dizziness, and weird dark and light spots on skin like bruises, varying sizes, darkest between bones in hand and toes especially, largest on thumb, both arms and feet and turns into funny brownish/ purple color. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Lymph node pain, Neck pain
Clinical narrative: lymph nodes till feel sore to this day; Sore arm and shoulder/soreness from neck to elbow; headaches for nearly 3 weeks; Sore arm and shoulder/soreness from neck to elbow; Sore arm and shoulder/soreness from neck to elbow; Fatigue for 3 weeks; injection site still itches to this day; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Sore arm and shoulder/soreness from neck to elbow), PAIN IN EXTREMITY (Sore arm and shoulder/soreness from neck to elbow), VACCINATION SITE PRURITUS (injection site still itches to this day), LYMPH NODE PAIN (lymph nodes till feel sore to this day) and ARTHRALGIA (Sore arm and shoulder/soreness from neck to elbow) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fish allergy and Drug allergy (allergy to codiene). Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) from 15-Jan-2020 to an unknown date for Stress and Anxiety.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced NECK PAIN (Sore arm and shoulder/soreness from neck to elbow), PAIN IN EXTREMITY (Sore arm and shoulder/soreness from neck to elbow), LYMPH NODE PAIN (lymph nodes till feel sore to this day), ARTHRALGIA (Sore arm and shoulder/soreness from neck to elbow) and HEADACHE (headaches for nearly 3 weeks). In March 2021, the patient experienced FATIGUE (Fatigue for 3 weeks). In 2021, the patient experienced VACCINATION SITE PRURITUS (injection site still itches to this day). On 31-Mar-2021, HEADACHE (headaches for nearly 3 weeks) had resolved. In 2021, FATIGUE (Fatigue for 3 weeks) had resolved. At the time of the report, NECK PAIN (Sore arm and shoulder/soreness from neck to elbow), PAIN IN EXTREMITY (Sore arm and shoulder/soreness from neck to elbow) and VACCINATION SITE PRURITUS (injection site still itches to this day) had not resolved and LYMPH NODE PAIN (lymph nodes till feel sore to this day) and ARTHRALGIA (Sore arm and shoulder/soreness from neck to elbow) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medication reported. Patients shoulder and arm were extremely sore since first vaccine. shoulder and lymph nodes till feel sore to this day, 19-Aug-2021. It was getting better slowly. When she first got the vaccine it was sore from her neck to elbow to the point she could not touch it for a week. The headaches for nearly 3 weeks. fatigue for 3 weeks  injection site still itches to this day. Patient received the 1st dose on 09-Mar-2021at 01:00 pm.     This case was linked to MOD-2021-079907 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pruritus
Clinical narrative: lymph nodes till feel sore to this day; Sore arm and shoulder/soreness from neck to elbow; headaches for nearly 3 weeks; Sore arm and shoulder/soreness from neck to elbow; Sore arm and shoulder/soreness from neck to elbow; Fatigue for 3 weeks; injection site still itches to this day; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Sore arm and shoulder/soreness from neck to elbow), PAIN IN EXTREMITY (Sore arm and shoulder/soreness from neck to elbow), VACCINATION SITE PRURITUS (injection site still itches to this day), LYMPH NODE PAIN (lymph nodes till feel sore to this day) and ARTHRALGIA (Sore arm and shoulder/soreness from neck to elbow) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fish allergy and Drug allergy (allergy to codiene). Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) from 15-Jan-2020 to an unknown date for Stress and Anxiety.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced NECK PAIN (Sore arm and shoulder/soreness from neck to elbow), PAIN IN EXTREMITY (Sore arm and shoulder/soreness from neck to elbow), LYMPH NODE PAIN (lymph nodes till feel sore to this day), ARTHRALGIA (Sore arm and shoulder/soreness from neck to elbow) and HEADACHE (headaches for nearly 3 weeks). In March 2021, the patient experienced FATIGUE (Fatigue for 3 weeks). In 2021, the patient experienced VACCINATION SITE PRURITUS (injection site still itches to this day). On 31-Mar-2021, HEADACHE (headaches for nearly 3 weeks) had resolved. In 2021, FATIGUE (Fatigue for 3 weeks) had resolved. At the time of the report, NECK PAIN (Sore arm and shoulder/soreness from neck to elbow), PAIN IN EXTREMITY (Sore arm and shoulder/soreness from neck to elbow) and VACCINATION SITE PRURITUS (injection site still itches to this day) had not resolved and LYMPH NODE PAIN (lymph nodes till feel sore to this day) and ARTHRALGIA (Sore arm and shoulder/soreness from neck to elbow) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medication reported. Patients shoulder and arm were extremely sore since first vaccine. shoulder and lymph nodes till feel sore to this day, 19-Aug-2021. It was getting better slowly. When she first got the vaccine it was sore from her neck to elbow to the point she could not touch it for a week. The headaches for nearly 3 weeks. fatigue for 3 weeks  injection site still itches to this day. Patient received the 1st dose on 09-Mar-2021at 01:00 pm.     This case was linked to MOD-2021-079907 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine, Illness, Incorrect dose administered, Swelling
Clinical narrative: he was swelling; felt sick for a whole day; it appears as if he is reacting to allergies in a more significant way than he has ever reacted to / after the second shot, he has been waking up and the allergies are really getting to him / the allergies are a constant thing; received both shots in April2021 (about 2-3 weeks apart); This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (he was swelling), ILLNESS (felt sick for a whole day), ALLERGY TO VACCINE (it appears as if he is reacting to allergies in a more significant way than he has ever reacted to / after the second shot, he has been waking up and the allergies are really getting to him / the allergies are a constant thing) and INCORRECT DOSE ADMINISTERED (received both shots in April2021 (about 2-3 weeks apart)) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included EPINEPHRINE (PRIMATENE [EPINEPHRINE]) for Allergy, VITAMIN C [ASCORBIC ACID] and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced SWELLING (he was swelling), ILLNESS (felt sick for a whole day), ALLERGY TO VACCINE (it appears as if he is reacting to allergies in a more significant way than he has ever reacted to / after the second shot, he has been waking up and the allergies are really getting to him / the allergies are a constant thing) and INCORRECT DOSE ADMINISTERED (received both shots in April2021 (about 2-3 weeks apart)). At the time of the report, SWELLING (he was swelling), ILLNESS (felt sick for a whole day) and ALLERGY TO VACCINE (it appears as if he is reacting to allergies in a more significant way than he has ever reacted to / after the second shot, he has been waking up and the allergies are really getting to him / the allergies are a constant thing) outcome was unknown and INCORRECT DOSE ADMINISTERED (received both shots in April2021 (about 2-3 weeks apart)) had resolved.            Patient took first dose vaccine on same month of April about 2-3 weeks prior to second dose. No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: significant follow received and contains events outcome updated to recovered.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Nausea, Oropharyngeal pain, Pruritus
Clinical narrative: intermittent Hives/urticaria; raised red rash that would disappear after a few minutes; Itchy; felt washed out; mild sore throat; low grade fever of 100 degrees Farenheight; slight nausea; sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (intermittent Hives/urticaria), OROPHARYNGEAL PAIN (mild sore throat), PYREXIA (low grade fever of 100 degrees Farenheight), NAUSEA (slight nausea) and FATIGUE (felt washed out) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0020A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (codeine,monistat,robaxin). Concomitant products included VACCINIUM SPP. (CRANBERRY [VACCINIUM SPP.]) for UTI, COLECALCIFEROL (VIT D3) and PYRIDOXINE HYDROCHLORIDE (VIT B6) for an unknown indication.    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore injection site arm). On 02-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (mild sore throat), PYREXIA (low grade fever of 100 degrees Farenheight) and NAUSEA (slight nausea). On 03-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (felt washed out). On 25-Apr-2021, the patient experienced RASH ERYTHEMATOUS (raised red rash that would disappear after a few minutes) and PRURITUS (Itchy). In May 2021, the patient experienced URTICARIA (intermittent Hives/urticaria). On 05-Feb-2021, VACCINATION SITE PAIN (sore injection site arm) had resolved. On 03-Mar-2021, OROPHARYNGEAL PAIN (mild sore throat), PYREXIA (low grade fever of 100 degrees Farenheight) and NAUSEA (slight nausea) had resolved. On 04-Mar-2021, FATIGUE (felt washed out) had resolved. On 25-Apr-2021, RASH ERYTHEMATOUS (raised red rash that would disappear after a few minutes) and PRURITUS (Itchy) had resolved. At the time of the report, URTICARIA (intermittent Hives/urticaria) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 100 (High) Low grade Fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient took Multi vitamin gummy.  No treatment medications were provided.   This case was linked to MOD-2021-238997.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up report is Non significant report include reporter email information were added. On 18-Aug-2021: Follow up report received on 18-AUG-2021 with new medical history added. new concomitant medication added. new events added.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash erythematous, Urticaria, Vaccination site pain
Clinical narrative: intermittent Hives/urticaria; raised red rash that would disappear after a few minutes; Itchy; felt washed out; mild sore throat; low grade fever of 100 degrees Farenheight; slight nausea; sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (intermittent Hives/urticaria), OROPHARYNGEAL PAIN (mild sore throat), PYREXIA (low grade fever of 100 degrees Farenheight), NAUSEA (slight nausea) and FATIGUE (felt washed out) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0020A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (codeine,monistat,robaxin). Concomitant products included VACCINIUM SPP. (CRANBERRY [VACCINIUM SPP.]) for UTI, COLECALCIFEROL (VIT D3) and PYRIDOXINE HYDROCHLORIDE (VIT B6) for an unknown indication.    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore injection site arm). On 02-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (mild sore throat), PYREXIA (low grade fever of 100 degrees Farenheight) and NAUSEA (slight nausea). On 03-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (felt washed out). On 25-Apr-2021, the patient experienced RASH ERYTHEMATOUS (raised red rash that would disappear after a few minutes) and PRURITUS (Itchy). In May 2021, the patient experienced URTICARIA (intermittent Hives/urticaria). On 05-Feb-2021, VACCINATION SITE PAIN (sore injection site arm) had resolved. On 03-Mar-2021, OROPHARYNGEAL PAIN (mild sore throat), PYREXIA (low grade fever of 100 degrees Farenheight) and NAUSEA (slight nausea) had resolved. On 04-Mar-2021, FATIGUE (felt washed out) had resolved. On 25-Apr-2021, RASH ERYTHEMATOUS (raised red rash that would disappear after a few minutes) and PRURITUS (Itchy) had resolved. At the time of the report, URTICARIA (intermittent Hives/urticaria) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 100 (High) Low grade Fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient took Multi vitamin gummy.  No treatment medications were provided.   This case was linked to MOD-2021-238997.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up report is Non significant report include reporter email information were added. On 18-Aug-2021: Follow up report received on 18-AUG-2021 with new medical history added. new concomitant medication added. new events added.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 20-May-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant products and Treatment medication were reported.   This case was linked to MOD-2021-200231, MOD-2021-245676, MOD-2021-245668 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Aug-2021: Follow up received, contains gender updated, dosage regimen details updated and race updated.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nervous system disorder
Clinical narrative: Hypoaesthesia; neurological problem s for the past 5 months; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Hypoaesthesia) and NERVOUS SYSTEM DISORDER (neurological problem s for the past 5 months) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced HYPOAESTHESIA (Hypoaesthesia). In 2021, the patient experienced NERVOUS SYSTEM DISORDER (neurological problem s for the past 5 months). At the time of the report, HYPOAESTHESIA (Hypoaesthesia) and NERVOUS SYSTEM DISORDER (neurological problem s for the past 5 months) had not resolved.            Concomitant product use was not provided by the reporter.  Had multiple pathological and biopsy test.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Follow up received contains event of neurological disorder and action taken updated from unknown to not applicable.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Covid rash on her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Covid rash on her arm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TOLTERODINE L-TARTRATE (DETROL) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Covid rash on her arm). At the time of the report, VACCINATION SITE RASH (Covid rash on her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided (after first dose).  The patient was going through menopause. She was having bladder problems before.   This case was linked to MOD-2021-250643 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: Non-significant Follow-up included  narrative updated
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Dysgeusia, Headache, Inappropriate schedule of product administration
Clinical narrative: Chest pain; Palpitation; Everything she tried to eat tasted like metal; Unusual headache; Fever of 102.7; Vomiting until the next day; Did not receive 2nd dose between 25-35 days after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), PALPITATIONS (Palpitation), DYSGEUSIA (Everything she tried to eat tasted like metal), HEADACHE (Unusual headache) and PYREXIA (Fever of 102.7) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jul-2021, the patient experienced CHEST PAIN (Chest pain), PALPITATIONS (Palpitation), DYSGEUSIA (Everything she tried to eat tasted like metal), HEADACHE (Unusual headache), PYREXIA (Fever of 102.7) and VOMITING (Vomiting until the next day). 06-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive 2nd dose between 25-35 days after the 1st dose). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 06-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive 2nd dose between 25-35 days after the 1st dose) had resolved. On 07-Jul-2021, VOMITING (Vomiting until the next day) had resolved. At the time of the report, CHEST PAIN (Chest pain), PALPITATIONS (Palpitation), DYSGEUSIA (Everything she tried to eat tasted like metal), HEADACHE (Unusual headache) and PYREXIA (Fever of 102.7) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jul-2021, Body temperature: 102.7 (High) 102.7.         No concomitant products were reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow up received and it contains no new information
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia, Vomiting
Clinical narrative: Chest pain; Palpitation; Everything she tried to eat tasted like metal; Unusual headache; Fever of 102.7; Vomiting until the next day; Did not receive 2nd dose between 25-35 days after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), PALPITATIONS (Palpitation), DYSGEUSIA (Everything she tried to eat tasted like metal), HEADACHE (Unusual headache) and PYREXIA (Fever of 102.7) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jul-2021, the patient experienced CHEST PAIN (Chest pain), PALPITATIONS (Palpitation), DYSGEUSIA (Everything she tried to eat tasted like metal), HEADACHE (Unusual headache), PYREXIA (Fever of 102.7) and VOMITING (Vomiting until the next day). 06-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive 2nd dose between 25-35 days after the 1st dose). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 06-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive 2nd dose between 25-35 days after the 1st dose) had resolved. On 07-Jul-2021, VOMITING (Vomiting until the next day) had resolved. At the time of the report, CHEST PAIN (Chest pain), PALPITATIONS (Palpitation), DYSGEUSIA (Everything she tried to eat tasted like metal), HEADACHE (Unusual headache) and PYREXIA (Fever of 102.7) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jul-2021, Body temperature: 102.7 (High) 102.7.         No concomitant products were reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow up received and it contains no new information
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Bradykinesia, Constipation, Feeling cold, Musculoskeletal stiffness
Clinical narrative: Stiffness all over; Constipation; Somehow my body seems to be slowing down; Felt cold; Loss of weight; Hair loss; blazing red itchy rash on my upper shot arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness all over), CONSTIPATION (Constipation), BRADYKINESIA (Somehow my body seems to be slowing down), FEELING COLD (Felt cold) and WEIGHT DECREASED (Loss of weight) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy. Concomitant products included METOPROLOL TARTRATE (METAPRO [METOPROLOL TARTRATE]) for TIA, CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDE (CANDEMOX [CANDESARTAN CILEXETIL;HYDROCHLOROTHIAZIDE]) for an unknown indication.   On 28-Jan-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced RASH PRURITIC (blazing red itchy rash on my upper shot arm). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness all over), CONSTIPATION (Constipation), BRADYKINESIA (Somehow my body seems to be slowing down), FEELING COLD (Felt cold), WEIGHT DECREASED (Loss of weight) and ALOPECIA (Hair loss). The patient was treated with METHYLCELLULOSE (CITRUCEL) for Constipation, at an unspecified dose and frequency. On 05-Mar-2021, RASH PRURITIC (blazing red itchy rash on my upper shot arm) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness all over), CONSTIPATION (Constipation) and BRADYKINESIA (Somehow my body seems to be slowing down) had not resolved, FEELING COLD (Felt cold) and WEIGHT DECREASED (Loss of weight) outcome was unknown and ALOPECIA (Hair loss) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Follow up received on 23 AUG 2021: Medical history, concomitant and treatment medications added, new events and outcomes were added
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Weight decreased
Clinical narrative: Stiffness all over; Constipation; Somehow my body seems to be slowing down; Felt cold; Loss of weight; Hair loss; blazing red itchy rash on my upper shot arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness all over), CONSTIPATION (Constipation), BRADYKINESIA (Somehow my body seems to be slowing down), FEELING COLD (Felt cold) and WEIGHT DECREASED (Loss of weight) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy. Concomitant products included METOPROLOL TARTRATE (METAPRO [METOPROLOL TARTRATE]) for TIA, CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDE (CANDEMOX [CANDESARTAN CILEXETIL;HYDROCHLOROTHIAZIDE]) for an unknown indication.   On 28-Jan-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced RASH PRURITIC (blazing red itchy rash on my upper shot arm). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness all over), CONSTIPATION (Constipation), BRADYKINESIA (Somehow my body seems to be slowing down), FEELING COLD (Felt cold), WEIGHT DECREASED (Loss of weight) and ALOPECIA (Hair loss). The patient was treated with METHYLCELLULOSE (CITRUCEL) for Constipation, at an unspecified dose and frequency. On 05-Mar-2021, RASH PRURITIC (blazing red itchy rash on my upper shot arm) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness all over), CONSTIPATION (Constipation) and BRADYKINESIA (Somehow my body seems to be slowing down) had not resolved, FEELING COLD (Felt cold) and WEIGHT DECREASED (Loss of weight) outcome was unknown and ALOPECIA (Hair loss) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Follow up received on 23 AUG 2021: Medical history, concomitant and treatment medications added, new events and outcomes were added
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Malaise, Product dose omission issue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (Diarrhea), MALAISE (Feeling sick) and PRODUCT DOSE OMISSION ISSUE (Not yet taken her second shot of Moderna Covid-19 Vaccine since 6Apr2021) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. Concurrent medical conditions included Food allergy and Drug allergy. On 06-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not yet taken her second shot of Moderna Covid-19 Vaccine since 6Apr2021). On 10-Apr-2021, the patient experienced DIARRHEA (Diarrhea) and MALAISE (Feeling sick). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) for Diarrhea, at an unspecified dose and frequency. At the time of the report, DIARRHEA (Diarrhea) and MALAISE (Feeling sick) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Not yet taken her second shot of Moderna Covid-19 Vaccine since 6Apr2021) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment information was reported. The patient took Pepto-Bismol and Kaopectate for the diarrhea, and an allergy pill. Side effects that were reported post vaccination were diarrhea and feeling sick for three weeks started 10-Apr-2021.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Functional gastrointestinal disorder, Headache, Pain in extremity
Clinical narrative: Stomach problems; Intestinal problems; Diarrhea; Bad headaches; Arm was hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was hurting), ABDOMINAL DISCOMFORT (Stomach problems), FUNCTIONAL GASTROINTESTINAL DISORDER (Intestinal problems), DIARRHOEA (Diarrhea) and HEADACHE (Bad headaches) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jul-2021, the patient experienced PAIN IN EXTREMITY (Arm was hurting). On 29-Jul-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach problems), FUNCTIONAL GASTROINTESTINAL DISORDER (Intestinal problems), DIARRHOEA (Diarrhea) and HEADACHE (Bad headaches). At the time of the report, PAIN IN EXTREMITY (Arm was hurting), ABDOMINAL DISCOMFORT (Stomach problems), FUNCTIONAL GASTROINTESTINAL DISORDER (Intestinal problems), DIARRHOEA (Diarrhea) and HEADACHE (Bad headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment product information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Didn't get the second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Didn't get the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Didn't get the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Didn't get the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported. No Treatment information was reported.  Reporter said that patient received the first dose of the Moderna COVID-19 on the first week of June and "life got in the way", the patient never received the second dose. When asked for clarification the caller said that the patient did not get the second dose because of work.  Upon follow up, the patient reported that the patient was doing fine, had received the second dose and the patient declined for follow up.   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: attached : narrative updated, Medication error ticked
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Mobility decreased, Vaccination site haemorrhage, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE, MOBILITY DECREASED, VACCINATION SITE PAIN, GAIT DISTURBANCE, and VACCINATION SITE PAIN in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jul-2021, the patient experienced VACCINATION SITE HAEMORRHAGE and VACCINATION SITE PAIN. On 03-Aug-2021, the patient experienced MOBILITY DECREASED, VACCINATION SITE PAIN, and GAIT DISTURBANCE. At the time of the report, VACCINATION SITE HAEMORRHAGE, MOBILITY DECREASED, VACCINATION SITE PAIN, and GAIT DISTURBANCE outcome was unknown and VACCINATION SITE PAIN had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No Relevant concomitant medications were provided. No Treatment information was provided. The patient received vaccine around 03:30 PM. She preferred injection in left arm, due to ongoing issues with right elbow. Regarding issues with her elbow, her physicians are in process of ruling out fracture vs tendonitis. The nurse had to use a cotton ball, because she bled when she got the injection.