chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Headache, Nausea
Clinical narrative: Adverse effects for both shots. Shot 1: April 1st @ 12:30PM. Lot ER8733. Sever pain on 5 spots on head and shoulder. Sever headache; fever, chills, nausea, red face that comes and goes. Symptoms lasted until April 13th.  Shot 2: April 22nd @ 8:05AM. Headache, nausea and fatigue began at 6:00PM on April 22nd. April 23rd through present: Severe fatigue; fever, chills, nausea, red face that comes and goes.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Adverse effects for both shots. Shot 1: April 1st @ 12:30PM. Lot ER8733. Sever pain on 5 spots on head and shoulder. Sever headache; fever, chills, nausea, red face that comes and goes. Symptoms lasted until April 13th.  Shot 2: April 22nd @ 8:05AM. Headache, nausea and fatigue began at 6:00PM on April 22nd. April 23rd through present: Severe fatigue; fever, chills, nausea, red face that comes and goes.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Pt reported mild dizziness. Denied other symptoms. Pt declined juice or water.  Pt reported feeling better and left to home with wife.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: FEVER; TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported . The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported 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 an unspecified date, the subject experienced fever, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and tired was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache, Nausea, Paraesthesia
Clinical narrative: CHEST PAIN; BILATERAL LEG SLEEPING AND LEFT ARM ALSO ASLEEP; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced chest pain. On APR-2021, the subject experienced bilateral leg sleeping and left arm also asleep. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced nausea. Treatment medications included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest pain, headache, nausea and bilateral leg sleeping and left arm also asleep was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: SORE ARM; SLIGHT FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-MAR-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 2021, the subject experienced sore arm. On 2021, the subject experienced slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight fever and sore arm was not reported. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Erythema, Feeling hot, Pain in extremity, Peripheral swelling
Clinical narrative: REDNESS OF THE LEFT ARM; SWELLING OF THE LEFT ARM; ITCHINESS OF THE LEFT ARM; HOT LEFT ARM IN TOUCH; LEG PAIN; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's past medical history included lymph node, and concurrent conditions included cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced redness of the left arm, swelling of the left arm, itchiness of the left arm, hot left arm in touch, and leg pain.  Laboratory data (dates unspecified) included: Blood test (NR: not provided) everything clear, and Diagnostic ultrasound (NR: not provided) everything clear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from redness of the left arm, swelling of the left arm, itchiness of the left arm, and leg pain, and the outcome of hot left arm in touch was not reported. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Ultrasound scan
Clinical narrative: REDNESS OF THE LEFT ARM; SWELLING OF THE LEFT ARM; ITCHINESS OF THE LEFT ARM; HOT LEFT ARM IN TOUCH; LEG PAIN; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's past medical history included lymph node, and concurrent conditions included cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced redness of the left arm, swelling of the left arm, itchiness of the left arm, hot left arm in touch, and leg pain.  Laboratory data (dates unspecified) included: Blood test (NR: not provided) everything clear, and Diagnostic ultrasound (NR: not provided) everything clear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from redness of the left arm, swelling of the left arm, itchiness of the left arm, and leg pain, and the outcome of hot left arm in touch was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS; ON AND OFF FEVER; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported 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 an unspecified date, the subject experienced chills, and on and off fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and on and off fever. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Seizure
Clinical narrative: Whole body convulsing all day; Not doing well after her Moderna vaccine; Tongue began to spasm  and hasn't quit/bad shape; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SEIZURE (Whole body convulsing all day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No recorded medical history).    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 SEIZURE (Whole body convulsing all day) (seriousness criterion medically significant), MALAISE (Not doing well after her Moderna vaccine) and MALAISE (Tongue began to spasm  and hasn't quit/bad shape). At the time of the report, SEIZURE (Whole body convulsing all day), MALAISE (Not doing well after her Moderna vaccine) and MALAISE (Tongue began to spasm  and hasn't quit/bad shape) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 12-Jan-2021: No specific follow-up information recorded. On 12-Jan-2021: No specific follow-up information recorded. On 12-Jan-2021: No specific follow-up information recorded. On 15-Jan-2021: No specific follow-up information recorded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Can not move my arm at all; Most painful vaccine iv'e ever gotten; 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 VACCINATION SITE MOVEMENT IMPAIRMENT (Can not move my arm at all) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse effect (No medical history 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, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Can not move my arm at all) (seriousness criterion disability) and VACCINATION SITE PAIN (Most painful vaccine iv'e ever gotten). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Can not move my arm at all) and VACCINATION SITE PAIN (Most painful vaccine iv'e ever gotten) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Case comment: Very limited information regarding these events has been provided at this time.  Further information has been requested.   Reporter did not allow further contact; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Disorientation, Dizziness, Dysphagia, Pruritus
Clinical narrative: had anaphylactic reaction after 12 days; itching; ringing in her head; wooziness; disorientation; trouble swallowing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (had anaphylactic reaction after 12 days) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy (History of reactions to food). Concomitant products included DIPHENHYDRAMINE for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced ANAPHYLACTIC REACTION (had anaphylactic reaction after 12 days) (seriousness criterion hospitalization), PRURITUS (itching), TINNITUS (ringing in her head), DIZZINESS (wooziness), DISORIENTATION (disorientation) and DYSPHAGIA (trouble swallowing). The patient was hospitalized on 14-Feb-2021 due to ANAPHYLACTIC REACTION. At the time of the report, ANAPHYLACTIC REACTION (had anaphylactic reaction after 12 days), PRURITUS (itching), TINNITUS (ringing in her head), DIZZINESS (wooziness), DISORIENTATION (disorientation) and DYSPHAGIA (trouble swallowing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Several days after the first Moderna vaccination on 14Feb2021, the husband reported that after dinner the patient experienced itching, ringing in her head, wooziness, trouble swallowing, and disorientation.  We called 911 and the ambulance came and took her to the hospital. time. At the emergency department, they did lot of tests, but negative result. On an unspecified date the patient was seen by an allergist and food allergies were ruled out by the allergist.  No additional treatment information was provided. Action taken was reported as unknown.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-081674 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Anaphylactic reaction captured in event tab as medically significant and the emergency department did lot of tests, but negative result.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-081674:Dose 1
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: had anaphylactic reaction after 12 days; itching; ringing in her head; wooziness; disorientation; trouble swallowing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (had anaphylactic reaction after 12 days) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy (History of reactions to food). Concomitant products included DIPHENHYDRAMINE for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced ANAPHYLACTIC REACTION (had anaphylactic reaction after 12 days) (seriousness criterion hospitalization), PRURITUS (itching), TINNITUS (ringing in her head), DIZZINESS (wooziness), DISORIENTATION (disorientation) and DYSPHAGIA (trouble swallowing). The patient was hospitalized on 14-Feb-2021 due to ANAPHYLACTIC REACTION. At the time of the report, ANAPHYLACTIC REACTION (had anaphylactic reaction after 12 days), PRURITUS (itching), TINNITUS (ringing in her head), DIZZINESS (wooziness), DISORIENTATION (disorientation) and DYSPHAGIA (trouble swallowing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Several days after the first Moderna vaccination on 14Feb2021, the husband reported that after dinner the patient experienced itching, ringing in her head, wooziness, trouble swallowing, and disorientation.  We called 911 and the ambulance came and took her to the hospital. time. At the emergency department, they did lot of tests, but negative result. On an unspecified date the patient was seen by an allergist and food allergies were ruled out by the allergist.  No additional treatment information was provided. Action taken was reported as unknown.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-081674 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Anaphylactic reaction captured in event tab as medically significant and the emergency department did lot of tests, but negative result.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-081674:Dose 1
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Itchy rash on chest, arm pits, neck, back, steadily spread until widespread on stomach, thighs; full body rash; Fine rash, like hives, like fine bumps all over; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash on chest, arm pits, neck, back, steadily spread until widespread on stomach, thighs; full body rash) and URTICARIA (Fine rash, like hives, like fine bumps all over) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 03iL20A) for COVID-19 vaccination.     The patient's past medical history included Allergy test (I have a history of topical allergies, the results of one allergy test is included.). Concurrent medical conditions included Allergy to chemicals (NA56 Quaternium 15, Formaldehyde, thiuram mix, ethyl cyanoacrylate, mercaptobenzothiazole, colophony, propolis), Allergy to topical drugs (Tixocortol 21 pivalate), Reaction to preservatives (methylisothiazolinone, methylchloroisothiazolinone together with methylisothiazolinone, methyldibromo glutaronitrile, Iodopropynyl butylcarbamate, 2-Bromo-2-nitropropane 1,3-diol, sorbic acid), Plastic sensitivity (plastics) and Topical adhesive reaction (adhesives, glues).   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH PRURITIC (Itchy rash on chest, arm pits, neck, back, steadily spread until widespread on stomach, thighs; full body rash) (seriousness criterion medically significant) and URTICARIA (Fine rash, like hives, like fine bumps all over) (seriousness criterion medically significant). At the time of the report, RASH PRURITIC (Itchy rash on chest, arm pits, neck, back, steadily spread until widespread on stomach, thighs; full body rash) and URTICARIA (Fine rash, like hives, like fine bumps all over) had not resolved.            Treatment was 6-day course of prednisone 10 milligrams in decreasing amounts, and then prednisone 20 milligrams for 16 days in decreasing amounts. The rash improved during treatment but returned when dose was decreased.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Consumer reported events met serious criteria of Intervention/Medically Important
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, CD4 lymphocytes decreased, Platelet count decreased
Clinical narrative: Her platelets went from 94 to 92; blood work showed low platelet and CD4 cell counts; This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT DECREASED (Her platelets went from 94 to 92) and CD4 LYMPHOCYTES DECREASED (blood work showed low platelet and CD4 cell counts) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 028L20A) for COVID-19 vaccination.     The patient's past medical history included Pacemaker insertion (cardiac) since an unknown date. Concurrent medical conditions included HIV positive, Diabetes and Bleeding (Her bleeding risk was so high at the moment that she had to cancel her pain shot.).   On 21-Jan-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) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PLATELET COUNT DECREASED (Her platelets went from 94 to 92) and CD4 LYMPHOCYTES DECREASED (blood work showed low platelet and CD4 cell counts) (seriousness criterion medically significant). At the time of the report, PLATELET COUNT DECREASED (Her platelets went from 94 to 92) and CD4 LYMPHOCYTES DECREASED (blood work showed low platelet and CD4 cell counts) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Blood test: abnormal (abnormal) abnormal. On 13-Apr-2021, Platelet count decreased: 92 (Low) Low.         No treatment information provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, this patient's concurrent medical conditions including viral infection (HIV) and diabetes may remain as confounders.  Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, this patient's concurrent medical conditions including viral infection (HIV) and diabetes may remain as confounders.  Further information has been requested.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: can't hear out of left ear; Ringing in both ears; Ringing in  the other ear that did not last long; Ringing in one ear that didn't last long; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (can't hear out of left ear) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced TINNITUS (Ringing in one ear that didn't last long). On 16-Apr-2021, the patient experienced TINNITUS (Ringing in  the other ear that did not last long). On 18-Apr-2021, the patient experienced TINNITUS (Ringing in both ears). On 20-Apr-2021, the patient experienced DEAFNESS UNILATERAL (can't hear out of left ear) (seriousness criterion medically significant). On 15-Apr-2021, TINNITUS (Ringing in one ear that didn't last long) had resolved. On 16-Apr-2021, TINNITUS (Ringing in  the other ear that did not last long) had resolved. At the time of the report, DEAFNESS UNILATERAL (can't hear out of left ear) and TINNITUS (Ringing in both ears) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Nausea, Pain in extremity, Paraesthesia
Clinical narrative: Numbness of face and lip; Face tingling; Felt sensitive to light; Nauseous; Really bad headache, left side of face; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness of face and lip) and PARAESTHESIA (Face tingling) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hysterectomy. Concurrent medical conditions included Shellfish allergy, Egg allergy, Food allergy (dairy) and Food allergy (different food when she was a child). Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 20-Apr-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). On 20-Apr-2021 at 12:00 PM, the patient experienced HEADACHE (Really bad headache, left side of face). On 21-Apr-2021, the patient experienced HYPOAESTHESIA (Numbness of face and lip) (seriousness criterion medically significant), PARAESTHESIA (Face tingling) (seriousness criterion medically significant), PHOTOPHOBIA (Felt sensitive to light) and NAUSEA (Nauseous). At the time of the report, HYPOAESTHESIA (Numbness of face and lip), PARAESTHESIA (Face tingling), PAIN IN EXTREMITY (Arm soreness), PHOTOPHOBIA (Felt sensitive to light), HEADACHE (Really bad headache, left side of face) and NAUSEA (Nauseous) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included ibuprofen.  Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship with the product use cannot be excluded.  Headache and nausea are consistent with the known safety profile of the product.; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship with the product use cannot be excluded.  Headache and nausea are consistent with the known safety profile of the product.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia
Clinical narrative: Numbness of face and lip; Face tingling; Felt sensitive to light; Nauseous; Really bad headache, left side of face; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness of face and lip) and PARAESTHESIA (Face tingling) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hysterectomy. Concurrent medical conditions included Shellfish allergy, Egg allergy, Food allergy (dairy) and Food allergy (different food when she was a child). Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 20-Apr-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). On 20-Apr-2021 at 12:00 PM, the patient experienced HEADACHE (Really bad headache, left side of face). On 21-Apr-2021, the patient experienced HYPOAESTHESIA (Numbness of face and lip) (seriousness criterion medically significant), PARAESTHESIA (Face tingling) (seriousness criterion medically significant), PHOTOPHOBIA (Felt sensitive to light) and NAUSEA (Nauseous). At the time of the report, HYPOAESTHESIA (Numbness of face and lip), PARAESTHESIA (Face tingling), PAIN IN EXTREMITY (Arm soreness), PHOTOPHOBIA (Felt sensitive to light), HEADACHE (Really bad headache, left side of face) and NAUSEA (Nauseous) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included ibuprofen.  Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship with the product use cannot be excluded.  Headache and nausea are consistent with the known safety profile of the product.; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship with the product use cannot be excluded.  Headache and nausea are consistent with the known safety profile of the product.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clots; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, 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 THROMBOSIS (Blood clots) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clots) was resolving.            The patient took the second vaccine on the 29th or 30th of March  Company Comment  Very limited information regarding this event has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-076604 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Chills, Deafness, Fatigue, Headache
Clinical narrative: Lost hearing; Machine noise, that is now a softer noise as of today; Ringing in the ear/tinnitus; Chills; Slight headache; More tired than normal; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Lost hearing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 026L70A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced DEAFNESS (Lost hearing) (seriousness criterion medically significant), TINNITUS (Machine noise, that is now a softer noise as of today), TINNITUS (Ringing in the ear/tinnitus), CHILLS (Chills), HEADACHE (Slight headache) and FATIGUE (More tired than normal). At the time of the report, DEAFNESS (Lost hearing), TINNITUS (Machine noise, that is now a softer noise as of today), CHILLS (Chills), HEADACHE (Slight headache) and FATIGUE (More tired than normal) outcome was unknown and TINNITUS (Ringing in the ear/tinnitus) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Acoustic stimulation tests: normal (normal) normal.         No concomitant medications were reported.  Her healthcare provider felt her symptoms were related to the vaccine. As of 22-Mar-2021 she still has ear symptoms that she describes to be "like a machine noise, that is now a softer noise". The patient is not pregnant and takes no routine medications. To treat her vaccine symptoms she took ibuprofen and aspirin as a treatment.  Ear, nose, and throat doctor and had a hearing test that had normal results. Sinuses were checked and were also clear. When asked was this present after her first dose which was on 9Feb2021 Lot Number:026L70A, she indicates no and that she only had a sore arm then. Both vaccine doses were given by the county health department and was given in her left upper arm. Second dose Lot Number: 022M20A.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Lost hearing; Machine noise, that is now a softer noise as of today; Ringing in the ear/tinnitus; Chills; Slight headache; More tired than normal; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Lost hearing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 026L70A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced DEAFNESS (Lost hearing) (seriousness criterion medically significant), TINNITUS (Machine noise, that is now a softer noise as of today), TINNITUS (Ringing in the ear/tinnitus), CHILLS (Chills), HEADACHE (Slight headache) and FATIGUE (More tired than normal). At the time of the report, DEAFNESS (Lost hearing), TINNITUS (Machine noise, that is now a softer noise as of today), CHILLS (Chills), HEADACHE (Slight headache) and FATIGUE (More tired than normal) outcome was unknown and TINNITUS (Ringing in the ear/tinnitus) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Acoustic stimulation tests: normal (normal) normal.         No concomitant medications were reported.  Her healthcare provider felt her symptoms were related to the vaccine. As of 22-Mar-2021 she still has ear symptoms that she describes to be "like a machine noise, that is now a softer noise". The patient is not pregnant and takes no routine medications. To treat her vaccine symptoms she took ibuprofen and aspirin as a treatment.  Ear, nose, and throat doctor and had a hearing test that had normal results. Sinuses were checked and were also clear. When asked was this present after her first dose which was on 9Feb2021 Lot Number:026L70A, she indicates no and that she only had a sore arm then. Both vaccine doses were given by the county health department and was given in her left upper arm. Second dose Lot Number: 022M20A.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Multiple sclerosis, SARS-CoV-2 antibody test
Clinical narrative: Very weak for about a week "worsening of multiple sclerosis"; Very weak for about a week; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MULTIPLE SCLEROSIS (Very weak for about a week "worsening of multiple sclerosis") in a 74-year-old male patient who received mRNA-1273 (batch nos. 001B21A and 006M21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included WARFARIN, METOPROLOL, OXYBUTYNIN and LEVOTHYROXINE for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273  (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced MULTIPLE SCLEROSIS (Very weak for about a week "worsening of multiple sclerosis") (seriousness criteria medically significant) and ASTHENIA (Very weak for about a week). On 20-Mar-2021, MULTIPLE SCLEROSIS (Very weak for about a week "worsening of multiple sclerosis") had resolved. At the time of the report, ASTHENIA (Very weak for about a week) outcome was unknown. Unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative. No treatment medications were reported. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.    Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle hypertrophy, Myalgia
Clinical narrative: 9 cm circumferance raised muscle; Deltoid muscle discomfort; This spontaneous case was reported by a health care professional and describes the occurrence of MUSCLE HYPERTROPHY (9 cm circumferance raised muscle) in a 69-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.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2020, the patient experienced MYALGIA (Deltoid muscle discomfort). On an unknown date, the patient experienced MUSCLE HYPERTROPHY (9 cm circumferance raised muscle) (seriousness criterion medically significant). At the time of the report, MUSCLE HYPERTROPHY (9 cm circumferance raised muscle) and MYALGIA (Deltoid muscle discomfort) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease, Drug level decreased
Clinical narrative: crohns disease aggravated; low level of humira in system; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of CROHN'S DISEASE (crohns disease aggravated) in a 47-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    No Medical History information was reported.   In 2020, the patient started ADALIMUMAB (HUMIRA) (unknown route) dosage form once a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CROHN'S DISEASE (crohns disease aggravated) (seriousness criterion medically significant) and DRUG LEVEL DECREASED (low level of humira in system). At the time of the report, CROHN'S DISEASE (crohns disease aggravated) and DRUG LEVEL DECREASED (low level of humira in system) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered CROHN'S DISEASE (crohns disease aggravated) to be probably related. No further causality assessment was provided for DRUG LEVEL DECREASED (low level of humira in system).    Action taken with mRNA-1273 in response to the events was not Applicable.  Concomitant products were not provided/unknown. Treatment medication were not reported/unknown.  Based on current available information and the temporal association between product use and he start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and he start date of the events a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Passed out; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) 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 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was unknown.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Influenza like illness, Malaise, Pain
Clinical narrative: shingles by her eye; real sick; real sick, severe flu-like symptoms; hurt so bad; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (shingles by her eye) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR), LISINOPRIL, CETIRIZINE and NAPROXEN for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.   On 13-Apr-2021, the patient experienced MALAISE (real sick), INFLUENZA LIKE ILLNESS (real sick, severe flu-like symptoms) and PAIN (hurt so bad). On 17-Apr-2021, the patient experienced HERPES ZOSTER (shingles by her eye) (seriousness criterion medically significant). At the time of the report, HERPES ZOSTER (shingles by her eye), MALAISE (real sick), INFLUENZA LIKE ILLNESS (real sick, severe flu-like symptoms) and PAIN (hurt so bad) outcome was unknown. Not Provided  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Treatment included valaciclovir hydrochloride, 1 GM 1 tab three times a day, erythromycin ointment in right eye three times daily and methylprednisolone Dose Pak.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, a causal relationship cannot be excluded. Some vaccines have been known to exacerbate latent herpes zoster.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Blister, Gastrointestinal pain, Herpes zoster, Neuralgia
Clinical narrative: swollen and tendered arm; swollen and tendered arm; nerve pain; sore gut; blisters due to shingles; Severe case of shingles; abdominal pain; kidney pain; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Severe case of shingles) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).   On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced HERPES ZOSTER (Severe case of shingles) (seriousness criterion medically significant), ABDOMINAL PAIN (abdominal pain) and RENAL PAIN (kidney pain). On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen and tendered arm), TENDERNESS (swollen and tendered arm), NEURALGIA (nerve pain), GASTROINTESTINAL PAIN (sore gut) and BLISTER (blisters due to shingles). At the time of the report, HERPES ZOSTER (Severe case of shingles), ABDOMINAL PAIN (abdominal pain), RENAL PAIN (kidney pain), PERIPHERAL SWELLING (swollen and tendered arm) and TENDERNESS (swollen and tendered arm) outcome was unknown and NEURALGIA (nerve pain), GASTROINTESTINAL PAIN (sore gut) and BLISTER (blisters due to shingles) had not resolved. Not Provided          No concomitant medications were reported. On 20APR2021, patient went to the emergency room. Patient is currently taking famciclovir 500 mg for his symptoms.  Company comment This case concerns a 76-year-old female with a serious unexpected event of herpes zoster, and nonserious unexpected abdominal pain, gastrointestinal pain, renal pain, peripheral swelling, tenderness, neuralgia, and blister. SAE onset 12 days after second dose mRNA-1273. Event outcomes ongoing or unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD21-81574, MODERNATX, INC.-MOD-2021-089399 (E2B Linked Report).; Sender's Comments: This case concerns a 76-year-old female with a serious unexpected event of herpes zoster, and nonserious unexpected abdominal pain, gastrointestinal pain, renal pain, peripheral swelling, tenderness, neuralgia, and blister. SAE onset 12 days after second dose mRNA-1273. Event outcomes ongoing or unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. MOD21-81574:Wife case MODERNATX, INC.-MOD-2021-089399:Husband case